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Introduction: First Nations are most at risk of developing end-stage kidney disease. Kidney transplantation is the best treatment option for these patients; however, First Nations donors are underrepresented. The aim of this study was to describe and understand barriers and facilitators of culturally safe organ transplantation and donation from the perspective of First Nations and Health Professionals in the Province of Quebec, Canada. Methods/Approach: This was a qualitative descriptive study using the decolonizing Two-Eyed Seeing approach. The sample consisted of First Nations people and health professionals living in Quebec, Canada, who have had an experience of organ transplantation or donation. Semi-structured interviews were conducted between May and September 2021 with 11 people, including 5 healthcare professionals and 6 First Nations people. Findings: This study enrolled 11 participants. Several individual and contextual factors influencing culturally safe organ transplantation and donation among First Nations people were identified: language barrier, impacts of relocation, lack of knowledge about transplantation, mistrust of the healthcare system, family support and accompaniment, and transplant testimonials. Discussion: This study identified several avenues for reinforcing culturally safe transplantation and donation among First Nations, including the presence of a companion in medical consultations, focusing on access to culturally safe accommodation and sharing transplant testimonials. Further work in partnership with First Nations is needed to improve access to culturally safe organ transplantation.
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BACKGROUND: Critical illness requiring invasive mechanical ventilation can precipitate important functional disability, contributing to multidimensional morbidity following admission to an intensive care unit (ICU). Early in-bed cycle ergometry added to usual physiotherapy may mitigate ICU-acquired physical function impairment. METHODS: We randomly assigned 360 adult ICU patients undergoing invasive mechanical ventilation to receive 30 minutes of early in-bed Cycling + Usual physiotherapy (n=178) or Usual physiotherapy alone (n=182). The primary outcome was the Physical Function ICU Test-scored (PFIT-s) at 3 days after discharge from the ICU (the score ranges from 0 to 10, with higher scores indicating better function). RESULTS: Cycling began within a median (interquartile range) of 2 (1 to 3) days of starting mechanical ventilation; patients received 3 (2 to 5) cycling sessions for a mean (±standard deviation) of 27.2 ± 6.6 minutes. In both groups, patients started Usual physiotherapy within 2 (2 to 4) days of mechanical ventilation and received 4 (2 to 7) Usual physiotherapy sessions. The duration of Usual physiotherapy was 23.7 ± 15.1 minutes in the Cycling + Usual physiotherapy group and 29.1 ± 13.2 minutes in the Usual physiotherapy group. No serious adverse events occurred in either group. Among survivors, the PFIT-s at 3 days after discharge from the ICU was 7.7 ± 1.7 in the Cycling + Usual physiotherapy group and 7.5 ± 1.7 in the Usual physiotherapy group (absolute difference, 0.23 points; 95% confidence interval, -0.19 to 0.65; P=0.29). CONCLUSIONS: Among adults receiving mechanical ventilation in the ICU, adding early in-bed Cycling to usual physiotherapy did not improve physical function at 3 days after discharge from the ICU compared with Usual physiotherapy alone. Cycling did not cause any serious adverse events. (Funded by the Canadian Institutes of Health Research and others; ClinicalTrials.gov numbers, NCT03471247 [full randomized clinical trial] and NCT02377830 [CYCLE Vanguard 46-patient internal pilot].).
Subject(s)
Critical Illness , Intensive Care Units , Physical Therapy Modalities , Respiration, Artificial , Humans , Respiration, Artificial/adverse effects , Female , Male , Middle Aged , Aged , Critical Illness/therapy , Ergometry/methods , AdultABSTRACT
BACKGROUND: Whether proton-pump inhibitors are beneficial or harmful for stress ulcer prophylaxis in critically ill patients undergoing invasive ventilation is unclear. METHODS: In this international, randomized trial, we assigned critically ill adults who were undergoing invasive ventilation to receive intravenous pantoprazole (at a dose of 40 mg daily) or matching placebo. The primary efficacy outcome was clinically important upper gastrointestinal bleeding in the intensive care unit (ICU) at 90 days, and the primary safety outcome was death from any cause at 90 days. Multiplicity-adjusted secondary outcomes included ventilator-associated pneumonia, Clostridioides difficile infection, and patient-important bleeding. RESULTS: A total of 4821 patients underwent randomization in 68 ICUs. Clinically important upper gastrointestinal bleeding occurred in 25 of 2385 patients (1.0%) receiving pantoprazole and in 84 of 2377 patients (3.5%) receiving placebo (hazard ratio, 0.30; 95% confidence interval [CI], 0.19 to 0.47; P<0.001). At 90 days, death was reported in 696 of 2390 patients (29.1%) in the pantoprazole group and in 734 of 2379 patients (30.9%) in the placebo group (hazard ratio, 0.94; 95% CI, 0.85 to 1.04; P = 0.25). Patient-important bleeding was reduced with pantoprazole; all other secondary outcomes were similar in the two groups. CONCLUSIONS: Among patients undergoing invasive ventilation, pantoprazole resulted in a significantly lower risk of clinically important upper gastrointestinal bleeding than placebo, with no significant effect on mortality. (Funded by the Canadian Institutes of Health Research and others; REVISE ClinicalTrials.gov number, NCT03374800.).
Subject(s)
Critical Illness , Pantoprazole , Proton Pump Inhibitors , Respiration, Artificial , Humans , Pantoprazole/therapeutic use , Pantoprazole/adverse effects , Pantoprazole/administration & dosage , Respiration, Artificial/adverse effects , Male , Middle Aged , Female , Proton Pump Inhibitors/therapeutic use , Proton Pump Inhibitors/adverse effects , Proton Pump Inhibitors/administration & dosage , Aged , Gastrointestinal Hemorrhage/prevention & control , 2-Pyridinylmethylsulfinylbenzimidazoles/therapeutic use , 2-Pyridinylmethylsulfinylbenzimidazoles/adverse effects , 2-Pyridinylmethylsulfinylbenzimidazoles/administration & dosage , Peptic Ulcer/prevention & control , Intensive Care Units , Pneumonia, Ventilator-Associated/prevention & control , Double-Blind Method , Stress, Physiological , AdultABSTRACT
INTRODUCTION: Most solid organ transplants originate from donors meeting criteria for death by neurological criteria (DNC). Within the organ donor, physiological responses to brain death increase the risk of ischaemia reperfusion injury and delayed graft function. Donor preconditioning with calcineurin inhibition may reduce this risk. METHODS AND ANALYSIS: We designed a multicentre placebo-controlled pilot randomised trial involving nine organ donation hospitals and all 28 transplant programmes in the Canadian provinces of Ontario and Québec. We planned to enrol 90 DNC donors and their approximately 324 organ recipients, totalling 414 participants. Donors receive an intravenous infusion of either tacrolimus 0.02 mg/kg over 4 hours prior to organ retrieval, or a matching placebo, while monitored in an intensive care unit for any haemodynamic changes during the infusion. Among all study organ recipients, we record measures of graft function for the first 7 days in hospital and we will record graft survival after 1 year. We examine the feasibility of this trial with respect to the proportion of all eligible donors enrolled and the proportion of all eligible transplant recipients consenting to receive a CINERGY organ transplant and to allow the use of their health data for study purposes. We will report these feasibility outcomes as proportions with 95% CIs. We also record any barriers encountered in the launch and in the implementation of this trial with detailed source documentation. ETHICS AND DISSEMINATION: We will disseminate trial results through publications and presentations at participating sites and conferences. This study has been approved by Health Canada (HC6-24-c241083) and by the Research Ethics Boards of all participating sites and in Québec (MP-31-2020-3348) and Clinical Trials Ontario (Project #3309). TRIAL REGISTRATION NUMBER: NCT05148715.
Subject(s)
Calcineurin Inhibitors , Delayed Graft Function , Kidney Transplantation , Tissue Donors , Adult , Female , Humans , Male , Brain Death , Calcineurin Inhibitors/administration & dosage , Calcineurin Inhibitors/therapeutic use , Delayed Graft Function/prevention & control , Graft Survival/drug effects , Immunosuppressive Agents/administration & dosage , Immunosuppressive Agents/therapeutic use , Multicenter Studies as Topic , Ontario , Pilot Projects , Quebec , Randomized Controlled Trials as Topic , Tacrolimus/therapeutic use , Tacrolimus/administration & dosageABSTRACT
OBJECTIVE: To characterise sex and gender-based analysis (SGBA) and diversity metric reporting, representation of female/women participants in acute care trials and temporal changes in reporting before and after publication of the 2016 Sex and Gender Equity in Research guideline. DESIGN: Systematic review. DATA SOURCES: We searched MEDLINE for trials published in five leading medical journals in 2014, 2018 and 2020. STUDY SELECTION: Trials that enrolled acutely ill adults, compared two or more interventions and reported at least one clinical outcome. DATA ABSTRACTION AND SYNTHESIS: 4 reviewers screened citations and 22 reviewers abstracted data, in duplicate. We compared reporting differences between intensive care unit (ICU) and cardiology trials. RESULTS: We included 88 trials (75 (85.2%) ICU and 13 (14.8%) cardiology) (n=111 428; 38 140 (34.2%) females/women). Of 23 (26.1%) trials that reported an SGBA, most used a forest plot (22 (95.7%)), were prespecified (21 (91.3%)) and reported a sex-by-intervention interaction with a significance test (19 (82.6%)). Discordant sex and gender terminology were found between headings and subheadings within baseline characteristics tables (17/32 (53.1%)) and between baseline characteristics tables and SGBA (4/23 (17.4%)). Only 25 acute care trials (28.4%) reported race or ethnicity. Participants were predominantly white (78.8%) and male/men (65.8%). No trial reported gendered-social factors. SGBA reporting and female/women representation did not improve temporally. Compared with ICU trials, cardiology trials reported significantly more SGBA (15/75 (20%) vs 8/13 (61.5%) p=0.005). CONCLUSIONS: Acute care trials in leading medical journals infrequently included SGBA, female/women and non-white trial participants, reported race or ethnicity and never reported gender-related factors. Substantial opportunity exists to improve SGBA and diversity metric reporting and recruitment of female/women participants in acute care trials. PROSPERO REGISTRATION NUMBER: CRD42022282565.
Subject(s)
Critical Care , Humans , Female , Male , Critical Care/statistics & numerical data , Periodicals as Topic/statistics & numerical data , Sex Factors , Journal Impact Factor , Clinical Trials as Topic , Gender Equity , CardiologyABSTRACT
BACKGROUND: The amount of same-day surgery has increased markedly worldwide in recent decades, but there remains limited evidence on chronic postsurgical pain in this setting. METHODS: This study assessed pain 90 days after ambulatory surgery in an international, multicenter prospective cohort study of patients at least 45 yr old with comorbidities or at least 65 yr old. Pain was assessed using the Brief Pain Inventory. Chronic postsurgical pain was defined as a change of more than 1 point in self-rated average pain at the surgical site between baseline and 90 days, and moderate to severe chronic postsurgical pain was defined as a score greater than 4 in self-rated average pain at the surgical site at 90 days. Risk factors for chronic postsurgical pain were identified using multivariable logistic regression. RESULTS: Between November 2021 and January 2023, a total of 2,054 participants were included, and chronic postsurgical pain occurred in 12% of participants, of whom 93.1% had new chronic pain at the surgical site (i.e., participants without pain before surgery). Moderate to severe chronic postsurgical pain occurred in 9% of overall participants. Factors associated with chronic postsurgical pain were active smoking (odds ratio, 1.82; 95% CI, 1.20 to 2.76), orthopedic surgery (odds ratio, 4.7; 95% CI, 2.24 to 9.7), plastic surgery (odds ratio, 4.3; 95% CI, 1.97 to 9.2), breast surgery (odds ratio, 2.74; 95% CI, 1.29 to 5.8), vascular surgery (odds ratio, 2.71; 95% CI, 1.09 to 6.7), and ethnicity (i.e., for Hispanic/Latino ethnicity, odds ratio, 3.41; 95% CI, 1.68 to 6.9 and for First Nations/native persons, odds ratio, 4.0; 95% CI, 1.05 to 15.4). CONCLUSIONS: Persistent postsurgical pain after same-day surgery is common, is usually moderate to severe in nature, and occurs mostly in patients without chronic pain before surgery.
Subject(s)
Ambulatory Surgical Procedures , Chronic Pain , Pain, Postoperative , Humans , Pain, Postoperative/epidemiology , Female , Prospective Studies , Male , Risk Factors , Chronic Pain/epidemiology , Middle Aged , Aged , Incidence , Cohort Studies , Ambulatory Surgical Procedures/adverse effects , Pain Measurement/methods , Pain Measurement/statistics & numerical dataABSTRACT
BACKGROUND: Donor interventions, including medications, protocols, and medical devices administered to donors, can enhance transplantable organ quality and quantity and maximize transplantation success. However, there is paucity of high-quality evidence about their effectiveness, in part because of ethical, practical, and regulatory challenges, and lack of guidance about conduct of donor intervention randomized controlled trials (RCTs). METHODS: With the vision to develop authoritative guidance for conduct of donor intervention RCTs, we convened a workshop of Canadian-United Kingdom experts in organ donation and transplantation ethics, research, and policy to identify stakeholders, explore unique challenges, and develop research agenda to inform future work in this promising field. RESULTS: Donor intervention trials should consider perspectives of broad group of stakeholders including donors, transplant recipients, and their families; researchers in donation and transplantation; research ethics boards; and healthcare providers and administrators involved in donation and transplantation. Unique challenges include (1) research ethics (living versus deceased status of the donor at the time of intervention, intervention versus outcomes assessment in different individuals, harm-benefit analysis in donors versus recipients, consent, and impact on research bystanders); (2) outcome data standardization and linkage; and (3) regulatory and governance considerations. CONCLUSIONS: Donor intervention RCTs hold potential to benefit organ transplantation outcomes but face unique research ethics, outcome data, and regulatory challenges. By developing research agenda to address these challenges, our workshop was an important first step toward developing Canada-United Kingdom guidance for donor intervention RCTs that are poised to improve the quality and availability of transplantable organs.
Subject(s)
Organ Transplantation , Randomized Controlled Trials as Topic , Tissue Donors , Tissue and Organ Procurement , Humans , United Kingdom , Canada , Randomized Controlled Trials as Topic/ethics , Randomized Controlled Trials as Topic/standards , Organ Transplantation/ethics , Tissue Donors/ethics , Tissue Donors/supply & distribution , Tissue and Organ Procurement/ethics , Tissue and Organ Procurement/standards , Stakeholder Participation , Research Design/standardsABSTRACT
Intensive care unit healthcare workers (ICU HCW) are at risk of mental health disorders during emerging disease outbreaks. Numerous cross-sectional studies have reported psychological distress, anxiety, and depression amongst ICU HCW during the COVID-19 pandemic. However, few studies have followed HCW longitudinally, and none of these have examined the association between COVID-19 workload and mental health. We conducted a longitudinal cohort study of 309 Canadian ICU HCW from April 2020 to August 2020, during the 1st wave of the COVID-19 pandemic. Psychological distress was assessed using the General Health Questionnaire 12-item scale (GHQ-12) at 3 timepoints: during the acceleration phase of the 1st wave (T1), the deceleration phase of the 1st wave (T2), and after the 1st wave had passed (T3). Clinically relevant psychological distress, defined as a GHQ-12 score ≥ 3, was identified in 64.7% of participants at T1, 41.0% at T2, and 34.6% at T3. Psychological distress was not associated with COVID-19 workload at T1. At T2, psychological distress was associated with the number of COVID-19 patients in the ICU (odds ratio [OR]: 1.06, 95% confidence interval [CI]: 1.00, 1.13) while at T3, when COVID-19 patient numbers were low, it was associated with the number of weekly hospital shifts with COVID-19 exposure (OR: 1.33, 95% CI: 1.09, 1.64). When analyzed longitudinally in a mixed effects model, pandemic timepoint was a stronger predictor of psychological distress (OR: 0.24, 95% CI: 0.15, 0.40 for T2 and OR: 0.16, 95% CI: 0.09, 0.27 for T3) than COVID-19 workload. Participants who showed persistent psychological distress at T3 were compared with those who showed recovery at T3. Persistent psychological distress was associated with a higher number of weekly shifts with COVID-19 exposure (OR: 1.97, 95% CI:1.33, 3.09) but not with a higher number of COVID-19 patients in the ICU (OR: 0.86, 95% CI: 0.76, 0.95). In summary, clinically relevant psychological distress was observed in a majority of ICU HCW during the acceleration phase of the 1st wave of the COVID-19 pandemic but decreased rapidly as the 1st wave progressed. Persistent psychological distress was associated with working more weekly shifts with COVID-19 exposure but not with higher numbers of COVID-19 patients in the ICU. In future emerging disease outbreaks, minimizing shifts with direct disease exposure may help alleviate symptoms for individuals with persistent psychological distress.
Subject(s)
COVID-19 , Psychological Distress , Humans , Longitudinal Studies , Pandemics , Cross-Sectional Studies , Workload , COVID-19/epidemiology , Canada/epidemiology , Cohort Studies , Health Personnel , Intensive Care Units , Depression/epidemiologyABSTRACT
Background and Purpose: The purpose of this article is to document the development and validation process of an instrument adapted for French-speaking nurses and to measure the occurrence of omitted nursing care (ONC) in the intensive care unit (ICU). Methods: An electronic Delphi panel, involving ICU nursing experts from the province of Quebec (Canada), was used to develop the intensive care unit omitted nursing care (ICU-ONC) instrument. For the validation process, an electronic cross-sectional survey was conducted. Results: A total of 564 nurses participated in the validation study. Exploratory factor analysis performed on 478 complete observations supports the presence of a single-factor structure for the 22-item ICU-ONC instrument. Coefficient alpha for the scale was .93, 95% confidence interval (CI) was [0.92, 0.94], item-partial total correlations ranged from .49 and .68, and the mean/median interitem correlations were .38 and .37, respectively. Moderate negative correlations were found between the ICU-ONC instrument overall score and two related constructs: nurses' perception of the quality as well as the safety of care. Conclusions: Our current understanding of ONC in the ICU is based on the results drawn from the administration of generic instruments to ICU nurses. The novel 22-item ICU-ONC instrument can help better estimate the occurrence of the phenomena in the ICU.
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Nurses , Nursing Staff, Hospital , Humans , Cross-Sectional Studies , Surveys and Questionnaires , Canada , Reproducibility of Results , Intensive Care UnitsABSTRACT
PURPOSE: Regional anesthesia may favour postoperative rehabilitation by inhibiting peripheral sensitization and secondary hyperalgesia. The literature on this subject is limited. In the present FUNCTION study, we sought to compare the functional recovery post orthopedic wrist surgery with regional versus general anesthesia. METHODS: We conducted a single-centre prospective observational cohort study in adult patients with a distal radial fracture. Functional recovery was assessed with validated psychometrics questionnaires (Quick Disabilities of Arm, Shoulder and Hand [QuickDASH] and Patient-Rated Wrist Evaluation [PRWE]), range of motion, and grip strength. We used a linear mixed regression model to assess the impact of the anesthesia technique on functional recovery. Postoperative pain and patient satisfaction were evaluated using a visual analog scale. RESULTS: We recruited 76 patients. At 12 weeks post surgery, there was no difference between the type of anesthesia and functional recovery with the QuickDASH (higher scores worse; regional anesthesia [RA], 22.7 vs general anesthesia [GA], 19.3; adjusted mean difference [aMD], -0.3; 95% confidence interval [CI], -9.6 to 9.0; P = 0.9) and PRWE (higher scores worse; RA group, 21.0 vs GA group, 20.5; aMD, -3.3; 95% CI, -12.1 to 5.6; P = 0.93) questionnaires. Range of motion, satisfaction, and postoperative pain were similar between groups. Right-hand grip strength was higher in the GA group. CONCLUSION: Regional anesthesia was not associated with improved functional recovery compared with general anesthesia. The dominance of the operated limb was a confusion factor in all evaluation modalities. Further research taking into account the dominance of the hand is necessary to establish the effects of regional anesthesia on functional recovery. STUDY REGISTRATION: ClinicalTrials.gov (NCT04541745); registered 9 September 2020.
RéSUMé: OBJECTIF: L'anesthésie régionale pourrait favoriser la rééducation postopératoire en inhibant la sensibilisation périphérique et l'hyperalgésie secondaire. La littérature à ce sujet est limitée. Dans la présente étude nommée FUNCTION, nous avons cherché à comparer la récupération fonctionnelle après une chirurgie orthopédique du poignet réalisée sous anesthésie régionale vs sous anesthésie générale. MéTHODE: Nous avons réalisé une étude de cohorte observationnelle prospective monocentrique auprès de patient·es adultes présentant une fracture radiale distale. La récupération fonctionnelle a été évaluée à l'aide de questionnaires psychométriques validés (questionnaires QuickDASH [Quick Disabilities of Arm, Shoulder and Hand] et PRWE [Patient-Rated Wrist Evaluation]), de l'amplitude des mouvements et de la force de préhension. Nous avons utilisé un modèle de régression linéaire mixte pour évaluer l'impact de la technique d'anesthésie sur la récupération fonctionnelle. La douleur postopératoire et la satisfaction des patient·es ont été évaluées à l'aide d'une échelle visuelle analogique. RéSULTATS: Nous avons recruté 76 personnes. Douze semaines après la chirurgie, il n'y avait aucune différence entre le type d'anesthésie et la récupération fonctionnelle selon le questionnaire QuickDASH (scores plus élevés les pires; anesthésie régionale [AR], 22,7 vs anesthésie générale [AG], 19,3; différence moyenne ajustée [DMa], −0,3; intervalle de confiance [IC] à 95 %, −9,6 à 9,0; P = 0,9) et PRWE (scores plus élevés les pires; groupe AR, 21,0 vs groupe AG, 20,5; DMa, −3,3; IC 95 %, −12,1 à 5,6; P = 0,93). L'amplitude des mouvements, la satisfaction et la douleur postopératoire étaient similaires entre les groupes. La force de préhension de la main droite était plus élevée dans le groupe AG. CONCLUSION: L'anesthésie régionale n'a pas été associée à une amélioration de la récupération fonctionnelle par rapport à l'anesthésie générale. La prédominance du membre opéré était un facteur de confusion dans toutes les modalités d'évaluation. D'autres recherches tenant compte du côté dominant au niveau des mains sont nécessaires pour déterminer les effets de l'anesthésie régionale sur la récupération fonctionnelle. ENREGISTREMENT DE L'éTUDE: ClinicalTrials.gov (NCT04541745); enregistrée le 9 septembre 2020.
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Importance: Blood collection for laboratory testing in intensive care unit (ICU) patients is a modifiable contributor to anemia and red blood cell (RBC) transfusion. Most blood withdrawn is not required for analysis and is discarded. Objective: To determine whether transitioning from standard-volume to small-volume vacuum tubes for blood collection in ICUs reduces RBC transfusion without compromising laboratory testing procedures. Design, Setting, and Participants: Stepped-wedge cluster randomized trial in 25 adult medical-surgical ICUs in Canada (February 5, 2019 to January 21, 2021). Interventions: ICUs were randomized to transition from standard-volume (n = 10â¯940) to small-volume tubes (n = 10â¯261) for laboratory testing. Main Outcomes and Measures: The primary outcome was RBC transfusion (units per patient per ICU stay). Secondary outcomes were patients receiving at least 1 RBC transfusion, hemoglobin decrease during ICU stay (adjusted for RBC transfusion), specimens with insufficient volume for testing, length of stay in the ICU and hospital, and mortality in the ICU and hospital. The primary analysis included patients admitted for 48 hours or more, excluding those admitted during a 5.5-month COVID-19-related trial hiatus. Results: In the primary analysis of 21â¯201 patients (mean age, 63.5 years; 39.9% female), which excluded 6210 patients admitted during the early COVID-19 pandemic, there was no significant difference in RBC units per patient per ICU stay (relative risk [RR], 0.91 [95% CI, 0.79 to 1.05]; P = .19; absolute reduction of 7.24 RBC units/100 patients per ICU stay [95% CI, -3.28 to 19.44]). In a prespecified secondary analysis (n = 27â¯411 patients), RBC units per patient per ICU stay decreased after transition from standard-volume to small-volume tubes (RR, 0.88 [95% CI, 0.77 to 1.00]; P = .04; absolute reduction of 9.84 RBC units/100 patients per ICU stay [95% CI, 0.24 to 20.76]). Median decrease in transfusion-adjusted hemoglobin was not statistically different in the primary population (mean difference, 0.10 g/dL [95% CI, -0.04 to 0.23]) and lower in the secondary population (mean difference, 0.17 g/dL [95% CI, 0.05 to 0.29]). Specimens with insufficient quantity for analysis were rare (≤0.03%) before and after transition. Conclusions and Relevance: Use of small-volume blood collection tubes in the ICU may decrease RBC transfusions without affecting laboratory analysis. Trial Registration: ClinicalTrials.gov Identifier: NCT03578419.
Subject(s)
Anemia , Blood Specimen Collection , Blood Transfusion , Female , Humans , Male , Middle Aged , Anemia/etiology , Anemia/therapy , Critical Care , Hemoglobins/analysis , Intensive Care Units , Blood Specimen Collection/methodsABSTRACT
BACKGROUND: This update summarizes key changes made to the protocol for the Frequency of Screening and Spontaneous Breathing Trial (SBT) Technique Trial-North American Weaning Collaborative (FAST-NAWC) trial since the publication of the original protocol. This multicenter, factorial design randomized controlled trial with concealed allocation, will compare the effect of both screening frequency (once vs. at least twice daily) to identify candidates to undergo a SBT and SBT technique [pressure support + positive end-expiratory pressure vs. T-piece] on the time to successful extubation (primary outcome) in 760 critically ill adults who are invasively ventilated for at least 24 h in 20 North American intensive care units. METHODS/DESIGN: Protocols for the pilot, factorial design trial and the full trial were previously published in J Clin Trials ( https://doi.org/10.4172/2167-0870.1000284 ) and Trials (https://doi: 10.1186/s13063-019-3641-8). As planned, participants enrolled in the FAST pilot trial will be included in the report of the full FAST-NAWC trial. In response to the onset of the coronavirus disease of 2019 (COVID-19) pandemic when approximately two thirds of enrollment was complete, we revised the protocol and consent form to include critically ill invasively ventilated patients with COVID-19. We also refined the statistical analysis plan (SAP) to reflect inclusion and reporting of participants with and without COVID-19. This update summarizes the changes made and their rationale and provides a refined SAP for the FAST-NAWC trial. These changes have been finalized before completion of trial follow-up and the commencement of data analysis. TRIAL REGISTRATION: Clinical Trials.gov NCT02399267.
Subject(s)
COVID-19 , Ventilator Weaning , Adult , Humans , Ventilator Weaning/methods , Critical Illness , Time Factors , North America , Respiration, Artificial , Randomized Controlled Trials as Topic , Multicenter Studies as TopicABSTRACT
Delirium is common after cardiac surgery and is associated with adverse outcomes. Administration of benzodiazepines before and after cardiac surgery is associated with delirium; guidelines recommend minimizing their use. Benzodiazepine administration during cardiac surgery remains common because of its recognized benefits. The Benzodiazepine-Free Cardiac Anesthesia for Reduction of Postoperative Delirium (B-Free) trial is a randomized cluster crossover trial evaluating whether an institutional policy of restricting intraoperative benzodiazepine administration (ie, ≥ 90% of patients do not receive benzodiazepines during cardiac surgery), as compared with a policy of liberal intraoperative benzodiazepine administration (ie, ≥ 90% of patients receive ≥ 0.03 mg/kg midazolam equivalent), reduces delirium. Hospitals performing ≥ 250 cardiac surgeries a year are included if their cardiac anesthesia group agrees to apply both benzodiazepine policies per their randomization, and patients are assessed for postoperative delirium every 12 hours in routine clinical care. Hospitals apply the restricted or liberal benzodiazepine policy during 12 to 18 crossover periods of 4 weeks each. Randomization for all periods takes place in advance of site startup; sites are notified of their allocated policy during the last week of each crossover period. Policies are applied to all patients undergoing cardiac surgery during the trial period. The primary outcome is the incidence of delirium at up to 72 hours after surgery. The B-Free trial will enroll ≥ 18,000 patients undergoing cardiac surgery at 20 hospitals across North America. Delirium is common after cardiac surgery, and benzodiazepines are associated with the occurrence of delirium. The B-Free trial will determine whether an institutional policy restricting the administration of benzodiazepines during cardiac surgery reduces the incidence of delirium after cardiac surgery. Clinicaltrials.gov registration number: NCT03928236 (First registered April 26, 2019).
L'état confusionnel est fréquent après une chirurgie cardiaque et il est associé à des complications. L'administration de benzodiazépines avant et après une chirurgie cardiaque est associée à l'état confusionnel; dans les lignes directrices, on recommande de réduire leur utilisation au minimum. L'administration de benzodiazépines pendant une chirurgie cardiaque demeure fréquente, en raison des leurs bienfaits reconnus. L'essai B-Free (Benzodiazepine-Free Cardiac Anesthesia for Reduction of Postoperative Delirium ou l'anesthésie sans benzodiazépine en contexte de chirurgie cardiaque pour la réduction de l'état confusionnel postopératoire) est un essai à répartition aléatoire par grappes et avec permutation, visant à évaluer si une politique institutionnelle de restriction de l'administration peropératoire de benzodiazépines (c.-à-d. que ≥ 90 % des patients ne reçoivent pas de benzodiazépines durant une chirurgie cardiaque) réduit l'état confusionnel, comparativement à une politique d'administration peropératoire libérale de benzodiazépines (c.-à-d. que ≥ 90 % des patients reçoivent ≥ 0,03 mg/kg d'équivalent du midazolam). Des hôpitaux effectuant au moins 250 chirurgies cardiaques par année sont inclus dans l'essai si leurs équipes d'anesthésie cardiaque acceptent d'appliquer les deux politiques relatives aux benzodiazépines en vertu de la répartition aléatoire et si les patients sont évalués toutes les 12 heures, en ce qui a trait à l'état confusionnel postopératoire, dans le cadre des soins cliniques habituels. Les hôpitaux mettent en Åuvre la politique d'administration restreinte ou libérale de benzodiazépines durant 12 à 18 périodes de permutation de 4 semaines chacune. La répartition aléatoire de l'ensemble des périodes a lieu avant le début de l'essai à l'hôpital; les établissements sont avisés de la politique qui leur est attribuée au cours de la dernière semaine de chaque période de permutation. Les politiques sont appliquées à tous les patients qui subissent une chirurgie cardiaque durant la période de l'essai. Le critère d'évaluation principal est l'incidence de l'état confusionnel dans les 72 heures suivant l'intervention chirurgicale. L'étude B-Free inclura au moins 18 000 patients qui subiront une chirurgie cardiaque dans 20 hôpitaux en l'Amérique du Nord. L'état confusionnel est fréquent après une chirurgie cardiaque, et les benzodiazépines sont associées à la survenue de l'état confusionnel. L'essai B-Free permettra de déterminer si une politique institutionnelle de restriction de l'administration de benzodiazépines durant une chirurgie cardiaque réduit l'incidence de l'état confusionnel après une telle chirurgie.Clinicaltrials.gov registration number: NCT03928236 (First registered April 26, 2019).
ABSTRACT
Background: Preconditioning deceased organ donors with calcineurin inhibitors (CNIs) may reduce ischemia-reperfusion injury to improve transplant outcomes. Methods: We searched MEDLINE, EMBASE, Cochrane Library, and conference proceedings for animal models of organ donation and transplantation, comparing donor treatment with CNIs with either placebo or no intervention, and evaluating outcomes for organ transplantation. Reviewers independently screened and selected studies, abstracted data, and assessed the risk of bias and clinical relevance of included studies. Where possible, we pooled results using meta-analysis; otherwise, we summarized findings descriptively. Results: Eighteen studies used various animals and a range of CNI agents and doses and evaluated their effects on a variety of transplant outcomes. The risk of bias and clinical applicability were poorly reported. Pooled analyses suggested benefit of CNI treatment on early graft function in renal transplants (3 studies; serum creatinine: ratio of means [RoM] 0.54; 95% confidence interval [CI], 0.34-0.86) but not for liver transplants (2 studies; serum alanine transaminase: RoM 0.61; 95% CI, 0.30-1.26; and serum aspartate aminotransferase: RoM 0.58; 95% CI, 0.26-1.31). We found no reduction in graft loss at 7 d (2 studies; risk ratio 0.54; 95% CI, 0.08-3.42). CNI treatment was associated with reduced transplant recipient levels of interleukin-6 (4 studies; RoM 0.36; 95% CI, 0.19-0.70), tumor necrosis factor-alpha (5 studies; RoM 0.36; 95% CI, 0.12-1.03), and cellular apoptosis (4 studies; RoM 0.30; 95% CI, 0.19-0.47). Conclusions: Although this compendium of animal experiments suggests that donor preconditioning with CNIs may improve early kidney graft function, the limited ability to reproduce a true clinical environment in animal experiments and to assess for risk of bias in these experiments is a serious weakness that precludes current clinical application.
ABSTRACT
Research on deceased organ donors has been hindered by concerns related to seeking research consent from transplant recipients. We undertook this qualitative study to elucidate solid organ transplant recipients views on organ donor research, their role in the consent for such research, and their preferences related to providing their data. We conducted interviews with 18 participants and three themes emerged from the data. The first centered around participant research literacy. The second described practical preferences of participating in research, and the third related to the connection between donor and recipient. We concluded that previously held views about the requirement for transplant recipients to have a consenting role in donor research is not always suitable.
Subject(s)
Tissue and Organ Procurement , Transplant Recipients , Humans , Tissue Donors , Qualitative Research , Literacy , Informed ConsentABSTRACT
INTRODUCTION: In-bed leg cycling with critically ill patients is a promising intervention aimed at minimising immobility, thus improving physical function following intensive care unit (ICU) discharge. We previously completed a pilot randomised controlled trial (RCT) which supported the feasibility of a large RCT. In this report, we describe the protocol for an international, multicentre RCT to determine the effectiveness of early in-bed cycling versus routine physiotherapy (PT) in critically ill, mechanically ventilated adults. METHODS AND ANALYSIS: We report a parallel group RCT of 360 patients in 17 medical-surgical ICUs and three countries. We include adults (≥18 years old), who could ambulate independently before their critical illness (with or without a gait aid), ≤4 days of invasive mechanical ventilation and ≤7 days ICU length of stay, and an expected additional 2-day ICU stay, and who do not fulfil any of the exclusion criteria. After obtaining informed consent, patients are randomised using a web-based, centralised system to either 30 min of in-bed cycling in addition to routine PT, 5 days per week, up to 28 days maximum, or routine PT alone. The primary outcome is the Physical Function ICU Test-scored (PFIT-s) at 3 days post-ICU discharge measured by assessors blinded to treatment allocation. Participants, ICU clinicians and research coordinators are not blinded to group assignment. Our sample size estimate was based on the identification of a 1-point mean difference in PFIT-s between groups. ETHICS AND DISSEMINATION: Critical Care Cycling to improve Lower Extremity (CYCLE) is approved by the Research Ethics Boards of all participating centres and Clinical Trials Ontario (Project 1345). We will disseminate trial results through publications and conference presentations. TRIAL REGISTRATION NUMBER: NCT03471247 (Full RCT); NCT02377830 (CYCLE Vanguard 46 patient internal pilot).
Subject(s)
Critical Illness , Respiration, Artificial , Adult , Humans , Adolescent , Critical Illness/therapy , Critical Care/methods , Intensive Care Units , Lower Extremity , Randomized Controlled Trials as Topic , Multicenter Studies as TopicABSTRACT
PURPOSE: Once difficult ventilation and intubation are declared, guidelines suggest the use of a supraglottic airway (SGA) as a rescue device to ventilate and, if oxygenation is restored, subsequently as an intubation conduit. Nevertheless, few trials have formally studied recent SGA devices in patients. Our objective was to compare the efficacy of three second-generation SGA devices as conduits for bronchoscopy-guided endotracheal intubation. METHODS: In this prospective, single-blinded three-arm randomized controlled trial, patients with an American Society of Anesthesiologists Physical Status of I-III undergoing general anesthesia were randomized to bronchoscopy-guided endotracheal intubation using AuraGain™, Air-Q® Blocker, or i-gel® devices. We excluded patients with contraindications to an SGA or drugs and who were pregnant or had a neck, spine, or respiratory anomaly. The primary outcome was intubation time, measured from SGA circuit disconnection to CO2 measurement. Secondary outcomes included ease, time, and success of SGA insertion; success of intubation on first attempt; overall intubation success; number of attempts to intubate; ease of intubation; and ease of SGA removals. RESULTS: One hundred and fifty patients were enrolled from March 2017 to January 2018. Median intubation times were similar across the three groups (Air-Q Blocker, 44 sec; AuraGain, 45 sec; i-gel, 36 sec; P = 0.08). The i-gel was faster to insert (i-gel: 10 sec; Air-Q Blocker, 16 sec; AuraGain, 16 sec; P < 0.001) and easier to insert (Air-Q Blocker vs i-gel, P = 0.001; AuraGain vs i-gel, P = 0.002). Success of SGA insertion, success of intubation, and number of attempts were similar. The Air-Q Blocker was easier to remove than the i-gel (P < 0.001). CONCLUSION: All three second-generation SGA devices performed similarly regarding intubation. Despite minor benefits of the i-gel, clinicians should select their SGA based on clinical experience. STUDY REGISTRATION: ClinicalTrials.gov (NCT02975466); registered on 29 November 2016.
RéSUMé: OBJECTIF: Une fois qu'une ventilation et une intubation difficiles sont déclarées, les lignes directrices préconisent le recours à un dispositif supraglottique comme modalité de sauvetage pour ventiler le patient et, si l'oxygénation est rétablie, être ensuite utilisé comme conduit d'intubation. Toutefois, peu d'études ont formellement analysé l'utilisation des dispositifs supraglottiques récents chez de véritbales patients. Notre objectif était de comparer l'efficacité de trois dispositifs supraglottiques de deuxième génération utilisés comme conduits pour l'intubation endotrachéale guidée par bronchoscopie. MéTHODE: Dans cette étude prospective randomisée contrôlée à trois bras et à simple insu, les patients de statut physique I-III selon l'American Society of Anesthesiologists bénéficiant d'une anesthésie générale ont été randomisés à recevoir une intubation endotrachéale guidée par bronchoscopie via les dispositifs AuraGain™, Air-Q® Blocker ou i-gel®. Nous avons exclu les patients présentant des contre-indications à l'utilisation d'un dispositif supraglottique ou aux médicaments, ainsi que les patientes enceintes et les patients présentant une anomalie au niveau du cou, de la colonne vertébrale ou des voies aériennes. Le critère d'évaluation principal était le temps d'intubation mesuré entre le moment de déconnexion du dispositif supraglottique du circuit et le moment de mesure du CO2. Les critères d'évaluation secondaires comprenaient la facilité, le délai et la réussite de l'insertion du dispositif supraglottique; la réussite de l'intubation à la première tentative; la réussite globale de l'intubation; le nombre de tentatives d'intubation; la facilité d'intubation; et la facilité de retrait du dispositif supraglottique. RéSULTATS: Cent cinquante patients ont été recrutés de mars 2017 à janvier 2018. Les délais d'intubation médians étaient similaires dans les trois groupes (Air-Q Blocker : 44 sec; AuraGain : 45 sec; i-gel : 36 sec; P = 0,08). L'i-gel était plus rapide à insérer (i-gel : 10 sec; Air-Q Blocker : 16 sec; AuraGain : 16 sec; P < 0,001) et plus facile à insérer (Air-Q Blocker vs i-gel : P = 0,001; AuraGain vs i-gel : P = 0,002). La réussite de l'insertion du dispositif supraglottique, la réussite de l'intubation et le nombre de tentatives étaient similaires. L'Air-Q Blocker était plus facile à retirer que l'i-gel (P < 0,001). CONCLUSION: Les trois dispositifs supraglottiques de deuxième génération ont tous affiché une performance similaire en matière d'intubation. Malgré des avantages mineurs de l'i-gel, les cliniciens devraient choisir leur dispositif supraglottique en fonction de leur expérience clinique. ENREGISTREMENT DE L'éTUDE: ClinicalTrials.gov (NCT02975466); enregistrée le 29 novembre 2016.
Subject(s)
Laryngeal Masks , Humans , Bronchoscopy , Prospective Studies , Intubation, Intratracheal , Airway ManagementABSTRACT
The objective of this review was to depict the physiological and clinical rationale for the use of vasopressin in hemodynamic support of organ donors. After summarizing the physiological, pharmacological concepts and preclinical findings, regarding vasopressin's pathophysiological impacts, we will present the available clinical data. DATA SOURCES: Detailed search strategies in PubMed, OVID Medline, and EMBASE were undertaken using Medical Subject Headings and Key Words. STUDY SELECTION: Physiological articles regarding brain death, and preclinical animal and human studies about the use of vasopressin or analogs, as an intervention in organ support for donation, were considered. DATA EXTRACTION: Two authors independently screened titles, abstracts, and full text of articles to determine eligibility. Data encompassing models, population, methodology, outcomes, and relevant concepts were extracted. DATA SYNTHESIS: Following brain death, profound reduction in sympathetic outflow is associated with reduced cardiac output, vascular tone, and hemodynamic instability in donors. In addition to reducing catecholamine needs and reversing diabetes insipidus, vasopressin has been shown to limit pulmonary injury and decrease systemic inflammatory response in animals. Several observational studies show the benefit of vasopressin on hemodynamic parameters and catecholamine sparing in donors. Small trials suggest that vasopressin increase organ procurement and have some survival benefit for recipients. However, the risk of bias is overall concerning, and therefore the quality of the evidence is deemed low. CONCLUSIONS: Despite potential impact on graft outcome and a protective effect through catecholamine support sparing, the benefit of vasopressin use in organ donors is based on low evidence. Well-designed observational and randomized controlled trials are warranted.