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1.
Intensive Care Med ; 49(11): 1305-1316, 2023 11.
Artigo em Inglês | MEDLINE | ID: mdl-37815560

RESUMO

BACKGROUND: There is controversy regarding the optimal renal-replacement therapy (RRT) modality for critically ill patients with acute kidney injury (AKI). METHODS: We conducted a secondary analysis of the STandard versus Accelerated Renal Replacement Therapy in Acute Kidney Injury (STARRT-AKI) trial to compare outcomes among patients who initiated RRT with either continuous renal replacement therapy (CRRT) or intermittent hemodialysis (IHD). We generated a propensity score for the likelihood of receiving CRRT and used inverse probability of treatment with overlap-weighting to address baseline inter-group differences. The primary outcome was a composite of death or RRT dependence at 90-days after randomization. RESULTS: We identified 1590 trial participants who initially received CRRT and 606 who initially received IHD. The composite outcome of death or RRT dependence at 90-days occurred in 823 (51.8%) patients who commenced CRRT and 329 (54.3%) patients who commenced IHD (unadjusted odds ratio (OR) 0.90; 95% confidence interval (CI) 0.75-1.09). After balancing baseline characteristics with overlap weighting, initial receipt of CRRT was associated with a lower risk of death or RRT dependence at 90-days compared with initial receipt of IHD (OR 0.81; 95% CI 0.66-0.99). This association was predominantly driven by a lower risk of RRT dependence at 90-days (OR 0.61; 95% CI 0.39-0.94). CONCLUSIONS: In critically ill patients with severe AKI, initiation of CRRT, as compared to IHD, was associated with a significant reduction in the composite outcome of death or RRT dependence at 90-days.


Assuntos
Injúria Renal Aguda , Terapia de Substituição Renal Contínua , Humanos , Injúria Renal Aguda/terapia , Estado Terminal/terapia , Diálise Renal , Terapia de Substituição Renal
2.
Science ; 381(6663): 1166-1167, 2023 Sep 15.
Artigo em Inglês | MEDLINE | ID: mdl-37708285

RESUMO

Highlights from the Science family of journals.

3.
J Emerg Nurs ; 49(4): 586-610, 2023 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-37074250

RESUMO

INTRODUCTION: This is a rapid review of the published evidence on the effectiveness of interventions for mitigating workplace violence against staff in hospital emergency departments. Focused on the specific needs of an urban emergency department in Canada, this project sought to address the question, "What interventions have evidence regarding effectiveness for addressing workplace patient/visitor violence toward staff in the emergency department?" METHODS: Following Cochrane Rapid Review methods, 5 electronic databases (MEDLINE via PubMed, Cochrane CENTRAL, Embase, PsycINFO, CINAHL) and Google Scholar were searched in April 2022 for intervention studies to reduce or mitigate workplace violence against staff in hospital emergency departments. Critical appraisal was conducted using Joanna Briggs Institute tools. Key study findings were synthesized narratively. RESULTS: Twenty-four studies (21 individual studies, 3 reviews) were included in this rapid review. A variety of strategies for reducing and mitigating workplace violence were identified and categorized as single or multicomponent interventions. Although most studies reported positive outcomes on workplace violence, the articles offered limited descriptions of the interventions and/or lacked robust data to demonstrate effectiveness. Insights from across the studies offer knowledge users information to support the development of comprehensive strategies to reduce workplace violence. DISCUSSION: Despite a large body of literature on workplace violence, there is little guidance on effective strategies to mitigate workplace violence in emergency departments. Evidence suggests that multicomponent approaches targeting staff, patients/visitors, and the emergency department environment are essential to addressing and mitigating workplace violence. More research is needed that provides robust evidence on effective violence prevention interventions.


Assuntos
Violência no Trabalho , Humanos , Violência no Trabalho/prevenção & controle , Serviço Hospitalar de Emergência , Local de Trabalho , Canadá
4.
Science ; 379(6631): 449-450, 2023 Feb 03.
Artigo em Inglês | MEDLINE | ID: mdl-36730395

RESUMO

Highlights from the Science family of journals.

5.
Sci Transl Med ; 14(661): eade6609, 2022 Sep 07.
Artigo em Inglês | MEDLINE | ID: mdl-36070370
7.
Science ; 375(6581): 625-627, 2022 Feb 11.
Artigo em Inglês | MEDLINE | ID: mdl-35143318

RESUMO

Highlights from the Science family of journals.

8.
Cochrane Database Syst Rev ; 10: CD013379, 2021 10 12.
Artigo em Inglês | MEDLINE | ID: mdl-34637143

RESUMO

BACKGROUND: Inability to communicate in a manner that can be understood causes extreme distress for people requiring an artificial airway and has implications for care quality and patient safety. Options for aided communication include non-vocal, speech-generating, and voice-enabling aids. OBJECTIVES: To assess effectiveness of communication aids for people requiring an artificial airway (endotracheal or tracheostomy tube), defined as the proportion of people able to: use a non-vocal communication aid to communicate at least one symptom, need, or preference; or use a voice-enabling communication aid to phonate to produce at least one intelligible word. To assess time to communication/phonation; perceptions of communication; communication quality/success; quality of life; psychological distress; length of stay and costs; and adverse events. SEARCH METHODS: We searched the Cochrane Library (Wiley version), MEDLINE (OvidSP), Embase (OvidSP), three other databases, and grey literature from inception to 30 July 2020. SELECTION CRITERIA: We included randomised controlled trials (RCTs), quasi-RCTs, cluster-RCTs, controlled non-randomised parallel group, and before-after studies evaluating communication aids used in adults with an artificial airway. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures recommended by Cochrane. Two review authors independently performed data extraction and assessment of risk of bias. MAIN RESULTS: We included 11 studies (1931 participants) conducted in intensive care units (ICUs). Eight evaluated non-vocal communication aids and three voice-enabling aids. Usual care was the comparator for all. For six studies, this comprised no aid; usual care in the remaining five studies comprised use of various communication aids. Overall, our confidence in results regarding effectiveness of communication interventions was very low due to imprecision, measurement heterogeneity, inconsistency in results, and most studies at high or unclear risk of bias across multiple domains. No non-vocal aid studies reported our primary outcome. We are uncertain of the effects of early use of a voice-enabling aid compared to routine use on ability to phonate at least one intelligible word (risk ratio (RR) 3.03, 95% confidence interval (CI) 0.18 to 50.08; 2 studies; very low-certainty evidence). Compared to usual care without aids, we are uncertain about effects of a non-vocal aid (communication board) on patient satisfaction (standardised mean difference (SMD) 2.92, 95% CI 1.52 to 4.33; 4 studies; very low-certainty evidence). No studies of non-vocal aids reported quality of life. Low-certainty evidence from two studies suggests early use of a voice-enabling aid may have no effect on quality of life (MD 2.27, 95% CI -7.21 to 11.75). Conceptual differences in measures of psychological distress precluded data pooling; however, intervention arm participants reported less distress suggesting there might be benefit, but our certainty in the evidence is very low. Low-certainty evidence suggest voice-enabling aids have little or no effect on ICU length of stay; we were unable to determine effects of non-vocal aids. Three studies reported different adverse events (physical restraint use, bleeding following tracheostomy, and respiratory parameters indicating respiratory decompensation). Adverse event rates were similar between arms in all three studies. However, uncertainty remains as to any harm associated with communication aids. AUTHORS' CONCLUSIONS: Due to a lack of high-quality studies, imprecision, inconsistency of results, and measurement heterogeneity,  the evidence provides insufficient information to guide practice as to which communication aid is more appropriate and when to use them. Understanding effectiveness of communication aids would benefit from development of a core outcome measurement set.


Assuntos
Comunicação , Unidades de Terapia Intensiva , Adulto , Viés , Humanos , Qualidade de Vida , Ventiladores Mecânicos
9.
Intensive Care Med ; 47(11): 1295-1302, 2021 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-34609548

RESUMO

PURPOSE: Oral chlorhexidine is used widely for mechanically ventilated patients to prevent pneumonia, but recent studies show an association with excess mortality. We examined whether de-adoption of chlorhexidine and parallel implementation of a standardized oral care bundle reduces intensive care unit (ICU) mortality in mechanically ventilated patients. METHODS: A stepped wedge cluster-randomized controlled trial with concurrent process evaluation in 6 ICUs in Toronto, Canada. Clusters were randomized to de-adopt chlorhexidine and implement a standardized oral care bundle at 2-month intervals. The primary outcome was ICU mortality. Secondary outcomes were time to infection-related ventilator-associated complications (IVACs), oral procedural pain and oral health dysfunction. An exploratory post hoc analysis examined time to extubation in survivors. RESULTS: A total of 3260 patients were enrolled; 1560 control, 1700 intervention. ICU mortality for the intervention and control periods were 399 (23.5%) and 330 (21.2%), respectively (adjusted odds ratio [aOR], 1.13; 95% confidence interval [CI] 0.82 to 1.54; P = 0.46). Time to IVACs (adjusted hazard ratio [aHR], 1.06; 95% CI 0.44 to 2.57; P = 0.90), time to extubation (aHR 1.03; 95% CI 0.85 to 1.23; P = 0.79) (survivors) and oral procedural pain (aOR, 0.62; 95% CI 0.34 to 1.10; P = 0.10) were similar between control and intervention periods. However, oral health dysfunction scores (- 0.96; 95% CI - 1.75 to - 0.17; P = 0.02) improved in the intervention period. CONCLUSION: Among mechanically ventilated ICU patients, no benefit was observed for de-adoption of chlorhexidine and implementation of an oral care bundle on ICU mortality, IVACs, oral procedural pain, or time to extubation. The intervention may improve oral health.


Assuntos
Pacotes de Assistência ao Paciente , Pneumonia Associada à Ventilação Mecânica , Clorexidina , Humanos , Unidades de Terapia Intensiva , Pneumonia Associada à Ventilação Mecânica/prevenção & controle , Respiração Artificial
10.
Anesthesiology ; 134(5): 760-769, 2021 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-33662121

RESUMO

BACKGROUND: Reverse triggering is a delayed asynchronous contraction of the diaphragm triggered by passive insufflation by the ventilator in sedated mechanically ventilated patients. The incidence of reverse triggering is unknown. This study aimed at determining the incidence of reverse triggering in critically ill patients under controlled ventilation. METHODS: In this ancillary study, patients were continuously monitored with a catheter measuring the electrical activity of the diaphragm. A method for automatic detection of reverse triggering using electrical activity of the diaphragm was developed in a derivation sample and validated in a subsequent sample. The authors assessed the predictive value of the software. In 39 recently intubated patients under assist-control ventilation, a 1-h recording obtained 24 h after intubation was used to determine the primary outcome of the study. The authors also compared patients' demographics, sedation depth, ventilation settings, and time to transition to assisted ventilation or extubation according to the median rate of reverse triggering. RESULTS: The positive and negative predictive value of the software for detecting reverse triggering were 0.74 (95% CI, 0.67 to 0.81) and 0.97 (95% CI, 0.96 to 0.98). Using a threshold of 1 µV of electrical activity to define diaphragm activation, median reverse triggering rate was 8% (range, 0.1 to 75), with 44% (17 of 39) of patients having greater than or equal to 10% of breaths with reverse triggering. Using a threshold of 3 µV, 26% (10 of 39) of patients had greater than or equal to 10% reverse triggering. Patients with more reverse triggering were more likely to progress to an assisted mode or extubation within the following 24 h (12 of 39 [68%]) vs. 7 of 20 [35%]; P = 0.039). CONCLUSIONS: Reverse triggering detection based on electrical activity of the diaphragm suggests that this asynchrony is highly prevalent at 24 h after intubation under assist-control ventilation. Reverse triggering seems to occur during the transition phase between deep sedation and the onset of patient triggering.


Assuntos
Diafragma/fisiologia , Monitorização Fisiológica/métodos , Contração Muscular/fisiologia , Respiração Artificial , Estado Terminal , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Tempo
11.
J Intensive Care Med ; 36(4): 404-412, 2021 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-31960743

RESUMO

PURPOSE: The 3 Wishes Project (3WP) promotes holistic end-of-life care in the intensive care unit (ICU) to honor dying patients, support families, and encourage clinician compassion. Organ donation is a wish that is sometimes made by, or on behalf of, critically ill patients. Our objective was to describe the interface between the 3WP and organ donation as experienced by families, clinicians, and organ donation coordinators. METHODS: In a multicenter evaluation of the 3WP in 4 Canadian ICUs, we conducted a thematic analysis of transcripts from interviews and focus groups with clinicians, organ donation coordinators, and families of dying or died patients for whom donation was considered. RESULTS: We analyzed transcripts from 26 interviews and 2 focus groups with 18 family members, 17 clinicians, and 6 organ donation coordinators. The central theme describes the mutual goals of the 3WP and organ donation-emphasizing personhood and agency across the temporal continuum of care. During family decision-making, conversations encouraged by the 3WP can facilitate preliminary discussions about donation. During preparation for donation, memory-making activities supported by the 3WP redirect focus toward personhood. During postmortem family care, the 3WP supports families, including when donation is unsuccessful, and highlights aspirational pursuits of donation while encouraging reflections on other fulfilled wishes. CONCLUSIONS: Organ donation and the 3WP provide complementary opportunities to engage in value-based conversations during the dying process. The shared values of these programs may help to incorporate organ donation and death into a person's life narrative and incorporate new life into a person's death narrative.


Assuntos
Assistência Terminal , Obtenção de Tecidos e Órgãos , Canadá , Morte , Tomada de Decisões , Família , Humanos , Unidades de Terapia Intensiva
12.
Am J Crit Care ; 29(6): 422-428, 2020 11 01.
Artigo em Inglês | MEDLINE | ID: mdl-33130860

RESUMO

BACKGROUND: A recent randomized trial of bereaved family members of patients who died in an intensive care unit identified symptoms of depression and posttraumatic stress in recipients of semistructured condolence letters. OBJECTIVES: To explore family member and clinician experiences with receiving or sending handwritten sympathy cards upon the death of patients involved in a personalized end-of-life intervention, the 3 Wishes Project. METHODS: Interviews and focus groups were held with 171 family members and 222 clinicians at 4 centers to discuss their experiences with the 3 Wishes Project. Interview transcripts were searched to identify participants who discussed sympathy cards. Data related to sympathy cards were independently coded by 2 investigators through conventional content analysis. RESULTS: Sympathy cards were discussed during 32 interviews (by 25 family members of 21 patients and by 11 clinicians) and 2 focus groups (8 other clinicians). Family members reported that personalized sympathy cards were a welcome surprise; they experienced them as a heartfelt act of compassion. Clinicians viewed cards as an opportunity to express shared humanity with families, reminding them that they and their loved one were not forgotten. Signing cards allowed clinicians to reminisce individually and collectively with colleagues. Family members and clinicians experienced sympathy cards as a meaningful continuation of care after a patient's death. CONCLUSIONS: Inviting clinicians who cared for deceased patients to offer personalized, handwritten condolences to bereaved family members may cultivate sincere and individualized expressions of sympathy that bereaved families appreciate after the death of patients involved in the 3 Wishes Project.


Assuntos
Luto , Relações Profissional-Família , Família , Humanos , Unidades de Terapia Intensiva , Assistência Terminal
13.
Sci Transl Med ; 12(566)2020 10 21.
Artigo em Inglês | MEDLINE | ID: mdl-33087506
14.
N Engl J Med ; 383(3): 240-251, 2020 07 16.
Artigo em Inglês | MEDLINE | ID: mdl-32668114

RESUMO

BACKGROUND: Acute kidney injury is common in critically ill patients, many of whom receive renal-replacement therapy. However, the most effective timing for the initiation of such therapy remains uncertain. METHODS: We conducted a multinational, randomized, controlled trial involving critically ill patients with severe acute kidney injury. Patients were randomly assigned to receive an accelerated strategy of renal-replacement therapy (in which therapy was initiated within 12 hours after the patient had met eligibility criteria) or a standard strategy (in which renal-replacement therapy was discouraged unless conventional indications developed or acute kidney injury persisted for >72 hours). The primary outcome was death from any cause at 90 days. RESULTS: Of the 3019 patients who had undergone randomization, 2927 (97.0%) were included in the modified intention-to-treat analysis (1465 in the accelerated-strategy group and 1462 in the standard-strategy group). Of these patients, renal-replacement therapy was performed in 1418 (96.8%) in the accelerated-strategy group and in 903 (61.8%) in the standard-strategy group. At 90 days, death had occurred in 643 patients (43.9%) in the accelerated-strategy group and in 639 (43.7%) in the standard-strategy group (relative risk, 1.00; 95% confidence interval [CI], 0.93 to 1.09; P = 0.92). Among survivors at 90 days, continued dependence on renal-replacement therapy was confirmed in 85 of 814 patients (10.4%) in the accelerated-strategy group and in 49 of 815 patients (6.0%) in the standard-strategy group (relative risk, 1.74; 95% CI, 1.24 to 2.43). Adverse events occurred in 346 of 1503 patients (23.0%) in the accelerated-strategy group and in 245 of 1489 patients (16.5%) in the standard-strategy group (P<0.001). CONCLUSIONS: Among critically ill patients with acute kidney injury, an accelerated renal-replacement strategy was not associated with a lower risk of death at 90 days than a standard strategy. (Funded by the Canadian Institutes of Health Research and others; STARRT-AKI ClinicalTrials.gov number, NCT02568722.).


Assuntos
Injúria Renal Aguda/terapia , Terapia de Substituição Renal , Injúria Renal Aguda/mortalidade , Idoso , Estado Terminal/terapia , Humanos , Análise de Intenção de Tratamento , Pessoa de Meia-Idade , Terapia de Substituição Renal/efeitos adversos , Tempo para o Tratamento , Resultado do Tratamento
15.
Am J Crit Care ; 29(4): 301-310, 2020 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-32607568

RESUMO

BACKGROUND: Most intensive care patients require substitute decision makers (SDMs) to make decisions. The SDMs may prefer an active, shared, or passive decision-making role. Role incongruence is when preferred and actual roles differ. OBJECTIVE: To evaluate the impact of decision-making role preferences and role incongruence on psychological distress symptoms in SDMs. METHODS: A multicenter, interviewer-administered survey was conducted among SDMs of critically ill adults. The Control Preferences Scale was used to evaluate role preferences. Psychological distress was defined as anxiety, depression, or posttraumatic stress symptoms with predefined cut points on the Hospital Anxiety and Depression Scale (score > 10 on the anxiety or the depression subscale) and Impact of Events Scale (score > 30). RESULTS: One hundred eighty SDMs were recruited; 64% responded. Most were white (71%) and female (65%); 46% were spouses. Role preferences varied: active, 24%; shared, 44%; and passive, 31%. Almost half (49%) reported incongruence. Symptom prevalence was 50% for posttraumatic stress, 32% for anxiety, and 16% for depression. Most (56%) reported some psychological distress. In multivariable logistic regression, the composite outcome of psychological distress was independently associated with patient death (odds ratio, 2.95; 95% CI, 1.08-8.02; P = .03), female sex of SDM (odds ratio, 2.96; 95% CI, 1.49-5.89; P = .002), and incongruence (odds ratio, 3.26; 95% CI, 1.67-6.36; P < .001). CONCLUSIONS: Adverse psychological symptoms are prevalent in SDMs of critically ill patients and are related to role incongruence.


Assuntos
Estado Terminal/psicologia , Procurador/psicologia , Estresse Psicológico/epidemiologia , APACHE , Fatores Etários , Idoso , Ansiedade/epidemiologia , Estudos Transversais , Tomada de Decisões , Depressão/epidemiologia , Feminino , Humanos , Unidades de Terapia Intensiva , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Respiração Artificial , Fatores Sexuais , Fatores Socioeconômicos
16.
BMC Palliat Care ; 19(1): 93, 2020 Jun 30.
Artigo em Inglês | MEDLINE | ID: mdl-32605623

RESUMO

BACKGROUND: The 3 Wishes Project (3WP) is an end-of-life program that honors the dignity of dying patients by fostering meaningful connections among patients, families, and clinicians. Since 2013, it has become embedded in the culture of end-of-life care in over 20 ICUs across North America. The purpose of the current study is to describe the variation in implementation of 3WP across sites, in order to ascertain which factors facilitated multicenter implementation, which factors remain consistent across sites, and which may be adapted to suit local needs. METHODS: Using the methodology of qualitative description, we collected interview and focus group data from 85 clinicians who participated in the successful initiation and sustainment of 3WP in 9 ICUs. We describe the transition between different models of 3WP implementation, from core clinical program to the incorporation of various research activities. We describe various sources of financial and in-kind resources accessed to support the program. RESULTS: Beyond sharing a common goal of improving end-of-life care, sites varied considerably in organizational context, staff complement, and resources. Despite these differences, the program was successfully implemented at each site and eventually evolved from a clinical or research intervention to a general approach to end-of-life care. Key to this success was flexibility and the empowerment of frontline staff to tailor the program to address identified needs with available resources. This adaptability was fueled by cross-pollination of ideas within and outside of each site, resulting in the establishment of a network of like-minded individuals with a shared purpose. CONCLUSIONS: The successful initiation and sustainment of 3WP relied on local adaptations to suit organizational needs and resources. The semi-structured nature of the program facilitated these adaptations, encouraged creative and important ways of relating within local clinical cultures, and reinforced the main tenet of the program: meaningful human connection at the end of life. Local adaptations also encouraged a team approach to care, supplementing the typical patient-clinician dyad by explicitly empowering the healthcare team to collectively recognize and respond to the needs of dying patients, families, and each other. TRIAL REGISTRATION: NCT04147169 , retrospectively registered with clinicaltrials.gov on October 31, 2019.


Assuntos
Empatia , Assistência Terminal/normas , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pesquisa Qualitativa , Assistência Terminal/métodos , Assistência Terminal/tendências
17.
J Pain Symptom Manage ; 60(5): 941-947, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-32574658

RESUMO

CONTEXT: Keepsakes are a relatively unexplored form of bereavement support that is frequently provided as part of the 3 Wishes Project (3WP). The 3WP is a palliative care intervention in which individualized wishes are implemented in the adult intensive care unit for dying patients and their families. OBJECTIVES: We aimed to characterize and enumerate the keepsakes that were created as part of the 3WP and to understand their value from the perspective of bereaved family members. METHODS: We performed a secondary analysis of family interviews during a multicenter study on the 3WP and characterized all wishes that involved keepsakes. Sixty interviews with family members regarding the 3WP were reanalyzed using qualitative analysis to identify substantive themes related to keepsakes. RESULTS: Of 730 patients, 345 (47%) received keepsakes as part of their participation in 3WP. Most keepsakes were either tangible items that served as reminders of the patient's presence (thumbprints and locks of hair) or technology-assisted items (photographs and word clouds). The median cost per keepsake wish was $8.50 (interquartile range $2.00-$25.00). Qualitative analysis revealed two major themes: keepsakes are tangible items that are highly valued by family members; and the creation of the keepsake with clinical staff is valued and viewed as a gesture of compassion. CONCLUSION: Keepsakes are common wishes that clinicians in the intensive care unit are able to provide and sometimes cocreate with families when patients are dying. Both the offering to create the keepsake and receipt of the final product are perceived by family members as helpful.


Assuntos
Luto , Assistência Terminal , Adulto , Morte , Família , Humanos , Unidades de Terapia Intensiva , Cuidados Paliativos
18.
Sci Transl Med ; 12(540)2020 04 22.
Artigo em Inglês | MEDLINE | ID: mdl-32321869
19.
Trials ; 20(1): 603, 2019 Oct 24.
Artigo em Inglês | MEDLINE | ID: mdl-31651364

RESUMO

BACKGROUND: Routine application of chlorhexidine oral rinse is recommended to reduce risk of ventilator-associated pneumonia (VAP) in mechanically ventilated patients. Recent reappraisal of the evidence from two meta-analyses suggests chlorhexidine may cause excess mortality in non-cardiac surgery patients and does not reduce VAP. Mechanisms for possible excess mortality are unclear. The CHORAL study will evaluate the impact of de-adopting chlorhexidine and implementing an oral care bundle (excluding chlorhexidine) on mortality, infection-related ventilator-associated complications (IVACs), and oral health status. METHODS: The CHORAL study is a stepped wedge, cluster randomized controlled trial in six academic intensive care units (ICUs) in Toronto, Canada. Clusters (ICU) will be randomly allocated to six sequential steps over a 14-month period to de-adopt oral chlorhexidine and implement a standardized oral care bundle (oral assessment, tooth brushing, moisturization, and secretion removal). On study commencement, all clusters begin with a control period in which the standard of care is oral chlorhexidine. Clusters then begin crossover from control to intervention every 2 months according to the randomization schedule. Participants include all mechanically ventilated adults eligible to receive the standardized oral care bundle. The primary outcome is ICU mortality; secondary outcomes are IVACs and oral health status. We will determine demographics, antibiotic usage, mortality, and IVAC rates from a validated local ICU clinical registry. With six clusters and 50 ventilated patients on average each month per cluster, we estimate that 4200 patients provide 80% power after accounting for intracluster correlation to detect an absolute reduction in mortality of 5.5%. We will analyze our primary outcome of mortality using a generalized linear mixed model adjusting for time to account for secular trends. We will conduct a process evaluation to determine intervention fidelity and to inform interpretation of the trial results. DISCUSSION: The CHORAL study will inform understanding of the effectiveness of de-adoption of oral chlorhexidine and implementation of a standardized oral care bundle for decreasing ICU mortality and IVAC rates while improving oral health status. Our process evaluation will inform clinicians and decision makers about intervention delivery to support future de-adoption if justified by trial results. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03382730 . Registered on December 26, 2017.


Assuntos
Anti-Infecciosos Locais/administração & dosagem , Clorexidina/administração & dosagem , Antissépticos Bucais/administração & dosagem , Higiene Bucal , Pacotes de Assistência ao Paciente , Pneumonia Associada à Ventilação Mecânica/prevenção & controle , Respiração Artificial/efeitos adversos , Anti-Infecciosos Locais/efeitos adversos , Clorexidina/efeitos adversos , Estado Terminal , Estudos Cross-Over , Drenagem , Humanos , Antissépticos Bucais/efeitos adversos , Estudos Multicêntricos como Assunto , Ontário , Higiene Bucal/efeitos adversos , Pacotes de Assistência ao Paciente/efeitos adversos , Pneumonia Associada à Ventilação Mecânica/diagnóstico , Pneumonia Associada à Ventilação Mecânica/etiologia , Pneumonia Associada à Ventilação Mecânica/mortalidade , Ensaios Clínicos Controlados Aleatórios como Assunto , Respiração Artificial/mortalidade , Fatores de Tempo , Escovação Dentária , Resultado do Tratamento
20.
Sci Transl Med ; 10(471)2018 12 12.
Artigo em Inglês | MEDLINE | ID: mdl-30541789
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