Multistudy Research Operations in the ICU: An Interprofessional Pandemic-Informed Approach.

Proliferation of COVID-19 research underscored the need for improved awareness among investigators, research staff and bedside clinicians of the operational details of clinical studies. The objective was to describe the genesis, goals, participation, procedures, and outcomes of two research operations committees in an academic ICU during the COVID-19 pandemic. DESIGN: Two-phase, single-center multistudy cohort. SETTING: University-affiliated ICU in Hamilton, ON, Canada. PATIENTS: Adult patients in the ICU, medical stepdown unit, or COVID-19 ward. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: An interprofessional COVID Collaborative was convened at the pandemic onset within our department, to proactively coordinate studies, help navigate multiple authentic consent encounters by different research staff, and determine which studies would be suitable for coenrollment. From March 2020 to May 2021, five non-COVID trials continued, two were paused then restarted, and five were launched. Over 15 months, 161 patients were involved in 215 trial enrollments, 110 (51.1%) of which were into a COVID treatment trial. The overall informed consent rate (proportion agreed of those eligible and approached including a priori and deferred consent models) was 83% (215/259). The informed consent rate was lower for COVID-19 trials (110/142, 77.5%) than other trials (105/117, 89.7%; p = 0.01). Patients with COVID-19 were significantly more likely to be coenrolled in two or more studies (29/77, 37.7%) compared with other patients (13/84, 15.5%; p = 0.002). Review items for each new study were collated, refined, and evolved into a modifiable checklist template to set up each study for success. The COVID Collaborative expanded to a more formal Department of Critical Care Research Operations Committee in June 2021, supporting sustainable research operations during and beyond the pandemic. CONCLUSIONS: Structured coordination and increased communication about research operations among diverse research stakeholders cultivated a sense of shared purpose and enhanced the integrity of clinical research operations.

Monitoring and auditing protocol adherence, data integrity and ethical conduct of a randomized clinical trial: A case study.

PURPOSE: To categorize, quantify and interpret findings documented in feedback letters of monitoring or auditing visits for an investigator-initiated, peer-review funded multicenter randomized trial testing probiotics for critically ill patients. MATERIALS & METHODS: In 37 Canadian centers, monitoring and auditing visits were performed by 3 trained individuals; findings were reported in feedback letters. At trial termination, we performed duplicate content analysis on letters, categorizing observations first into unique findings, followed by 10 pre-determined trial quality management domains. We further classified each observation into a) missing operational records, b) errors in process, and potential threats to c) data integrity, d) patient privacy or e) safety. RESULTS: Across 37 monitoring or auditing visits, 75 unique findings were categorized into 10 domains. Most frequently, observations were in domains of training documentation (180/566 [32%]) and the informed consent process (133/566 [23%]). Most observations were missing operational records (438/566 [77%]) rather than errors in process (128/566 [23%]). Of 75 findings, 13 (62/566 observations [11%]) posed a potential threat to data integrity, 1 (1/566 observation [0.18%]) to patient privacy, and 9 (49/566 observations [8.7%]) to patient safety. CONCLUSIONS: Monitoring and auditing findings predominantly concerned missing documentation with minimal threats to data integrity, patient privacy or safety. TRIAL REGISTRATION: PROSPECT (Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial): NCT02462590.

Sacrifice and solidarity: a qualitative study of family experiences of death and bereavement in critical care settings during the pandemic.

BACKGROUND: Pandemic-related restrictions are expected to continue to shape end-of-life care and impact the experiences of dying hospitalised patients and their families. OBJECTIVE: To understand families' experiences of loss and bereavement during and after the death of their loved one amidst the SARS-CoV-2 (COVID-19) pandemic. DESIGN: Qualitative descriptive study. SETTING: Three acute care units in a Canadian tertiary care hospital. PARTICIPANTS: Family members of 28 hospitalised patients who died from March-July 2020. MAIN OUTCOME MEASURES: Qualitative semistructured interviews conducted 6-16 months after patient death inquired about family experiences before and beyond the death of their loved one and garnered suggestions to improve end-of-life care. RESULTS: Pandemic restrictions had consequences for families of dying hospitalised patients. Most family members described an attitude of acquiescence, some framing their experience as a sacrifice made for the public good. Families appreciated how clinicians engendered trust in the name of social solidarity while trying to mitigate the negative impact of family separation. However, fears about the patient's experience of isolation and changes to postmortem rituals also created despair and contributed to long-lasting grief. CONCLUSION: Profound loss and enduring grief were described by family members whose final connections to their loved one were constrained by pandemic circumstances. Families observed solidarity among clinical staff and experienced a sense of unity with staff, which alleviated some distress. Their suggestions to improve end-of-life care given pandemic restrictions included frequent, flexible communication, exceptions for family presence when safe, and targeted efforts to connect patients whose isolation is intensified by functional impairment or limited technological access. TRIAL REGISTRATION NUMBER: NCT04602520; Results.

Community implementation of the 3 Wishes Project: an observational study of a compassionate end-of-life care initiative for critically ill patients.

BACKGROUND: The 3 Wishes Project (3WP) promotes a personalized dying experience by eliciting and facilitating individualized terminal wishes for patients, families and the clinicians caring for them. We aimed to evaluate the adaptability of the 3WP to a community intensive care unit (ICU), and to describe the patients cared for with this palliative approach, as well as local implementation strategies. METHODS: The 3WP was implemented in a 15-bed community hospital ICU in southern Ontario from 2017 to 2019. In this observational, descriptive study, we invited adult patients (≥ 18 yr) whose risk of death was deemed to be 95% or greater by the attending physician, or patients undergoing withdrawal of life-support to participate. We abstracted patient data from medical records, as well as the type, timing and cost of each wish, which person or service made and facilitated each wish, and if and why wishes were completed or not. We summarized data both narratively and quantitatively. RESULTS: The 3WP helped to realize 479 (99.2%) of 483 terminal wishes for 101 dying patients. This initiative was introduced as an interprofessional intervention and championed by nursing staff who were responsible for most patient enrolment and wish facilitation. Wishes included humanizing the ICU environment for the patient with belongings and blankets, musical performances, smudging and bathing ceremonies, and keepsakes. The cost was $5.39 per patient (standard deviation $22.40), with 430 (89.8%) wishes incurring no cost. Wishes made directly by patients accounted for 30 (6.2%) of wishes; those from family members and ICU staff accounted for 236 (48.9%) and 238 (49.3%) of wishes, respectively. The program comforted patients and their loved ones, motivating clinicians to sustain this end-of-life intervention. INTERPRETATION: We documented successful implementation of the 3WP in a community hospital, showing program adaptability and uptake outside of academic centres at relatively low cost. The lack of strict protocolization and personalized design of this intervention underscores its inherent flexibility, with potential to promote individualized end-of-life care in nonacademic hospital wards, homes or hospice.

Scale-up and sustainability of a personalized end-of-life care intervention: a longitudinal mixed-methods study.

BACKGROUND: Scaling-up and sustaining healthcare interventions can be challenging. Our objective was to describe how the 3 Wishes Project (3WP), a personalized end-of-life intervention, was scaled-up and sustained in an intensive care unit (ICU). METHODS: In a longitudinal mixed-methods study from January 12,013 - December 31, 2018, dying patients and families were invited to participate if the probability of patient death was > 95% or after a decision to withdraw life support. A research team member or bedside clinician learned more about each of the patients and their family, then elicited and implemented at least 3 personalized wishes for patients and/or family members. We used a qualitative descriptive approach to analyze interviews and focus groups conducted with 25 clinicians who cared for the enrolled patients. We used descriptive statistics to summarize patient, wish, and clinician characteristics, and analyzed outcome data in quarters using Statistical Process Control charts. The primary outcome was enrollment of terminally ill patients and respective families; the secondary outcome was the number of wishes per patient; tertiary outcomes included wish features and stakeholder involvement. RESULTS: Both qualitative and quantitative analyses suggested a three-phase approach to the scale-up of this intervention during which 369 dying patients were enrolled, having 2039 terminal wishes implemented. From a research project to clinical program to an approach to practice, we documented a three-fold increase in enrolment with a five-fold increase in total wishes implemented, without a change in cost. Beginning as a study, the protocol provided structure; starting gradually enabled frontline staff to experience and recognize the value of acts of compassion for patients, families, and clinicians. The transition to a clinical program was marked by handover from the research staff to bedside staff, whereby project catalysts mentored project champions to create staff partnerships, and family engagement became more intentional. The final transition involved empowering staff to integrate the program as an approach to care, expanding it within and beyond the organization. CONCLUSIONS: The 3WP is an end-of-life intervention which was implemented as a study, scaled-up into a clinical program, and sustained by becoming integrated into practice as an approach to care.

Organ Donation at the End of Life: Experiences From the 3 Wishes Project.

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.

Clinician Perspectives on Caring for Dying Patients During the Pandemic : A Mixed-Methods Study.

BACKGROUND: The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has affected the hospital experience for patients, visitors, and staff. OBJECTIVE: To understand clinician perspectives on adaptations to end-of-life care for dying patients and their families during the pandemic. DESIGN: Mixed-methods embedded study. (ClinicalTrials.gov: NCT04602520). SETTING: 3 acute care medical units in a tertiary care hospital from 16 March to 1 July 2020. PARTICIPANTS: 45 dying patients, 45 family members, and 45 clinicians. INTERVENTION: During the pandemic, clinicians continued an existing practice of collating personal information about dying patients and "what matters most," eliciting wishes, and implementing acts of compassion. MEASUREMENTS: Themes from semistructured clinician interviews that were summarized with representative quotations. RESULTS: Many barriers to end-of-life care arose because of infection control practices that mandated visiting restrictions and personal protective equipment, with attendant practical and psychological consequences. During hospitalization, family visits inside or outside the patient's room were possible for 36 patients (80.0%); 13 patients (28.9%) had virtual visits with a relative or friend. At the time of death, 20 patients (44.4%) had a family member at the bedside. Clinicians endeavored to prevent unmarked deaths by adopting advocacy roles to "fill the gap" of absent family and by initiating new and established ways to connect patients and relatives. LIMITATION: Absence of clinician symptom or wellness metrics; a single-center design. CONCLUSION: Clinicians expressed their humanity through several intentional practices to preserve personalized, compassionate end-of-life care for dying hospitalized patients during the SARS-CoV-2 pandemic. PRIMARY FUNDING SOURCE: Canadian Institutes of Health Research and Canadian Critical Care Trials Group Research Coordinator Fund.

Experiences of Bereaved Family Members Receiving Commemorative Paintings: A Qualitative Study.

Importance: Although family members of patients who die in the intensive care unit commonly experience long-term psychological distress, end-of-life bereavement support programs for such relatives are uncommon. Whether art influences the grief experience of families is largely unexplored. Objective: To explore the influence of personalized paintings created to honor deceased critically ill patients on family members' bereavement experience. Design, Setting, and Participants: A qualitative descriptive analysis was conducted of semistructured interviews of grieving relatives who received a painting after the death of their loved one. The deceased patients were from a 21-bed medical-surgical intensive care unit. Eleven families were invited to receive a painting, of whom 1 family declined. A total of 22 family members of 10 patients who died in the intensive care unit were interviewed in the study between July 11, 2017, and May 19, 2019. Interventions: Patients were enrolled in an end-of-life care program that elicits and implements wishes of patients and their families to bring peace during the dying process. Selected families of 10 decedents were invited to receive a painting to honor their loved one 1 to 10 months after the patient's death. Using details about the patient's life story, the artist created individualized paintings to commemorate each patient. Main Outcomes and Measures: The experiences of family members receiving a personalized painting and its reported influence on their grieving experience. Results: The family members of 10 decedents (mean [SD] age, 60 [14] years; 5 women [50%]; 8 White patients [80%]) were interviewed. The central theme of art to facilitate healing was illustrated through the following domains: the cocreation process, painting narratives, postmortem connections, and legacy. The process of cocreating the paintings with the artist and family members involved reminiscing, storytelling, and creativity. Family members emphasized the role of art to facilitate healing, exemplified through connections with images portrayed that deeply resonated with memories of their loved one. Participants indicated that the paintings validated that the patient was remembered, helped families feel less alone during a time of grief, honored the loved one's life, and enhanced connections between family members and clinicians. Conclusions and Relevance: This qualitative study's findings suggest that the creation of personalized paintings commemorating the lives of patients may help foster legacy and postmortem connections with clinicians and may help family members in their healing process.

Family and Clinician Experiences of Sympathy Cards in the 3 Wishes Project.

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.

Principles Guiding Nonpandemic Critical Care Research During a Pandemic.

OBJECTIVES: To describe the importance of critical care clinical research that is not pandemic-focused during pandemic times; outline principles to assist in the prioritization of nonpandemic research during pandemic times; and propose a guiding framework for decisions about whether, when and how to continue nonpandemic research while still honoring the moral and scientific imperative to launch research that is pandemic-focused. DESIGN/DATA SOURCES: Using in-person, email, and videoconference exchanges, we convened an interprofessional clinical research group, conducted a literature review of empirical studies, ethics documents and expert commentaries (2010 to present), and viewed traditional and social media posts (March 2020 to May 2020). Stakeholder consultation involved scientific, ethics, clinical, and administrative leaders. SETTING: Clinical research in the ICU. PATIENTS: Patients with and without coronavirus disease 2019. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: While clinical research should be prioritized to advantage patients with coronavirus disease 2019 in order to care for affected patients, it ideally would not unduly disadvantage patients without coronavirus disease 2019. Thus, timely, rigorous, relevant, and ethical clinical research is needed to improve the care and optimize outcomes for both patients with and without coronavirus disease 2019, acknowledging how many studies that are not exclusively focused on coronavirus disease 2019 remain relevant to patients with coronavirus disease 2019. Considerations to continue nonpandemic-focused research include the status of the pandemic, local jurisdictional guidance, capacity and safety of bedside and research personnel, disposition of patients already enrolled in nonpandemic studies, analyzing characteristics of each nonpandemic-focused study, research oversight, and final reporting requirements. CONCLUSIONS: Deliberation about continuing nonpandemic research should use objective, transparent criteria considering several aspects of the research process such as bedside and research staff safety, infection control, the informed consent model, protocol complexity, data collection, and implementation integrity. Decisions to pause or pursue nonpandemic research should be proportionate, transparent, and revisited as the pandemic abates.

Expanding the 3 Wishes Project for compassionate end-of-life care: a qualitative evaluation of local adaptations.

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.

Building organizational compassion among teams delivering end-of-life care in the intensive care unit: The 3 Wishes Project.

BACKGROUND: The 3 Wishes Project is a semistructured program that improves the quality of care for patients dying in the intensive care unit by eliciting and implementing wishes. This simple intervention honors the legacy of patients and eases family grief, forging human connections between family members and clinicians. AIM: To examine how the 3 Wishes Project enables collective patterns of compassion between patients, families, clinicians, and managerial leaders in the intensive care unit. DESIGN: Using a qualitative descriptive approach, interviews and focus groups were used to collect data from family members of dying patients, clinicians, and institutional leaders. Unconstrained directed qualitative content analysis was performed using Organizational Compassion as the analytic framework. SETTING/PARTICIPANTS: Four North American intensive care units, participants were 74 family members of dying patients, 72 frontline clinicians, and 20 managerial leaders. RESULTS: The policies and processes of the 3 Wishes Project exemplify organizational compassion by supporting individuals in the intensive care unit to collectively notice, feel, and respond to suffering. As an intervention that enables and empowers clinicians to engage in acts of kindness to enhance end-of-life care, the 3 Wishes Project is particularly well situated to encourage collective responses to suffering and promote compassion between patients, family members, and clinicians. CONCLUSIONS: Examining the 3 Wishes Project through the lens of organizational compassion reveals the potential of this program to cultivate the capacity for people to collectively notice, feel, and respond to suffering. Our data document multidirectional demonstrations of compassion between clinicians and family members, forging the type of human connections that may foster resilience.

Compassionate End-of-Life Care: Mixed-Methods Multisite Evaluation of the 3 Wishes Project.

Background: The 3 Wishes Project (3WP) is an end-of-life program that aims to honor the dignity of dying patients by creating meaningful patient- and family-centered memories while promoting humanistic interprofessional care. Objective: To determine whether this palliative intervention could be successfully implemented-defined as demonstrating value, transferability, affordability, and sustainability-beyond the intensive care unit in which it was created. Design: Mixed-methods formative program evaluation. (ClinicalTrials.gov: NCT04147169). Setting: 4 North American intensive care units. Participants: Dying patients, their families, clinicians, hospital managers, and administrators. Intervention: Wishes from dying patients, family members, and clinicians were elicited and implemented. Measurements: Patient characteristics and processes of care; the number, type, and cost of each wish; and semistructured interviews and focus groups with family members, clinicians, and managers. Results: A total of 730 patients were enrolled, and 3407 wishes were elicited. Qualitative data were gathered from 75 family members, 72 clinicians, and 20 managers or hospital administrators. Value included intentional comforting of families as they honored the lives and legacies of their loved ones while inspiring compassionate clinical care. Factors promoting transferability included family appreciation and a collaborative intensive care unit culture committed to dignity-conserving end-of-life care. Staff participation evolved from passive support to professional agency. Program initiation required minimal investment for reusable materials; thereafter, the mean cost was $5.19 (SD, $17.14) per wish. Sustainability was demonstrated by the continuation of 3WP at each site after study completion. Limitation: This descriptive formative evaluation describes tertiary care center-specific experiences rather than aiming for generalizability to all jurisdictions. Conclusion: The 3WP is a transferrable, affordable, and sustainable program that provides value to dying patients, their families, clinicians, and institutions. Primary Funding Source: Greenwall Foundation.

Fostering humanism: a mixed methods evaluation of the Footprints Project in critical care.

OBJECTIVES: The objectives of this mixed-methods study were to assess the uptake, sustainability and influence of the Footprints Project. SETTING: Twenty-two-bed university-affiliated ICU in Hamilton, Canada. PARTICIPANTS: ICU patients admitted and their families, as well as clinicians. INTERVENTIONS: We developed a personalised patient Footprints Form and Whiteboard to facilitate holistic, patient-centred care, to inform clinical encounters, and to create deeper connections among patients, families and clinicians. OUTCOME MEASURES: We conducted 3 audits to examine uptake and sustainability. We conducted semi-structured interviews with 10 clinicians, and held 5 focus groups with 25 clinicians; and we interviewed 5 patients and 13 family representatives of 5 patients who survived and 5 who died in the ICU. Transcripts were analysed using qualitative content analysis. RESULTS: The Footprints Project facilitated holistic, patient-centred care by setting the stage for patient and family experience, motivating the patient and humanising the patient for clinicians. Through informing clinical encounters, Footprints helped clinicians initiate more personal conversations, foster deeper connections and guide treatment. Professional practice influences included more focused attention on the patient, enhanced interdisciplinary communication and changes in community culture. Initially used in 15.8% of patients (audit A), uptake increased to 51.4% in audit B, and was sustained at 57.8% in audit C. CONCLUSIONS: By sharing valuable personal information about patients before and beyond their illness on individualised whiteboards at each bedside, the Footprints Project fosters humanism in critical care practice.

Multicentre pilot randomised clinical trial of early in-bed cycle ergometry with ventilated patients.

Introduction: Acute rehabilitation in critically ill patients can improve post-intensive care unit (post-ICU) physical function. In-bed cycling early in a patient's ICU stay is a promising intervention. The objective of this study was to determine the feasibility of recruitment, intervention delivery and retention in a multi centre randomised clinical trial (RCT) of early in-bed cycling with mechanically ventilated (MV) patients. Methods: We conducted a pilot RCT conducted in seven Canadian medical-surgical ICUs. We enrolled adults who could ambulate independently before ICU admission, within the first 4 days of invasive MV and first 7 days of ICU admission. Following informed consent, patients underwent concealed randomisation to either 30 min/day of in-bed cycling and routine physiotherapy (Cycling) or routine physiotherapy alone (Routine) for 5 days/week, until ICU discharge. Our feasibility outcome targets included: accrual of 1-2 patients/month/site; >80% cycling protocol delivery; >80% outcomes measured and >80% blinded outcome measures at hospital discharge. We report ascertainment rates for our primary outcome for the main trial (Physical Function ICU Test-scored (PFIT-s) at hospital discharge). Results: Between 3/2015 and 6/2016, we randomised 66 patients (36 Cycling, 30 Routine). Our consent rate was 84.6 % (66/78). Patient accrual was (mean (SD)) 1.1 (0.3) patients/month/site. Cycling occurred in 79.3% (146/184) of eligible sessions, with a median (IQR) session duration of 30.5 (30.0, 30.7) min. We recorded 43 (97.7%) PFIT-s scores at hospital discharge and 37 (86.0%) of these assessments were blinded. Discussion: Our pilot RCT suggests that a future multicentre RCT of early in-bed cycling for MV patients in the ICU is feasible. Trial registration number: NCT02377830.

TryCYCLE: A Prospective Study of the Safety and Feasibility of Early In-Bed Cycling in Mechanically Ventilated Patients.

INTRODUCTION: The objective of this study was to assess the safety and feasibility of in-bed cycling started within the first 4 days of mechanical ventilation (MV) to inform a future randomized clinical trial. METHODS: We conducted a 33-patient prospective cohort study in a 21-bed adult academic medical-surgical intensive care unit (ICU) in Hamilton, ON, Canada. We included adult patients (≥ 18 years) receiving MV who walked independently pre-ICU. Our intervention was 30 minutes of in-bed supine cycling 6 days/week in the ICU. Our primary outcome was Safety (termination), measured as events prompting cycling termination; secondary Safety (disconnection or dislodgement) outcomes included catheter/tube dislodgements. Feasibility was measured as consent rate and fidelity to intervention. For our primary outcome, we calculated the binary proportion and 95% confidence interval (CI). RESULTS: From 10/2013-8/2014, we obtained consent from 34 of 37 patients approached (91.9%), 33 of whom received in-bed cycling. Of those who cycled, 16(48.4%) were female, the mean (SD) age was 65.8(12.2) years, and APACHE II score was 24.3(6.7); 29(87.9%) had medical admitting diagnoses. Cycling termination was infrequent (2.0%, 95% CI: 0.8%-4.9%) and no device dislodgements occurred. Cycling began a median [IQR] of 3 [2, 4] days after ICU admission; patients received 5 [3, 8] cycling sessions with a median duration of 30.7 [21.6, 30.8] minutes per session. During 205 total cycling sessions, patients were receiving invasive MV (150 [73.1%]), vasopressors (6 [2.9%]), sedative or analgesic infusions (77 [37.6%]) and dialysis (4 [2.0%]). CONCLUSIONS: Early cycling within the first 4 days of MV among hemodynamically stable patients is safe and feasible. Research to evaluate the effect of early cycling on patient function is warranted. TRIAL REGISTRATION: Clinicaltrials.gov: NCT01885442.

Assessment of Postresuscitation Volume Status by Bioimpedance Analysis in Patients with Sepsis in the Intensive Care Unit: A Pilot Observational Study.

Background. Bioimpedance analysis (BIA) is a novel method of assessing a patient's volume status. Objective. We sought to determine the feasibility of using vector length (VL), derived from bioimpedance analysis (BIA), in the assessment of postresuscitation volume status in intensive care unit (ICU) patients with sepsis. Method. This was a prospective observational single-center study. Our primary outcome was feasibility. Secondary clinical outcomes included ventilator status and acute kidney injury. Proof of concept was sought by correlating baseline VL measurements with other known measures of volume status. Results. BIA was feasible to perform in the ICU. We screened 655 patients, identified 78 eligible patients, and approached 64 for consent. We enrolled 60 patients (consent rate of 93.8%) over 12 months. For each 50-unit increase in VL, there was an associated 22% increase in the probability of not requiring invasive mechanical ventilation (IMV) (p = 0.13). Baseline VL correlated with other measures of volume expansion including serum pro-BNP levels, peripheral edema, and central venous pressure (CVP). Conclusion. It is feasible to use BIA to predict postresuscitation volume status and patient-important outcomes in septic ICU patients. Trial Registration. This trial is registered with clinicaltrials.gov NCT01379404 registered on June 7, 2011.

Bleeding during critical illness: a prospective cohort study using a new measurement tool.

PURPOSE: To estimate the incidence, severity, duration and consequences of bleeding during critical illness, and to test the performance characteristics of a new bleeding assessment tool. METHODS: Clinical bleeding assessments were performed prospectively on 100 consecutive patients admitted to a medical-surgical intensive care unit (ICU) using a novel bleeding measurement tool called HEmorrhage MEasurement (HEME). Bleeding assessments were done daily in duplicate and independently by blinded, trained assessors. Inter-rater agreement and construct validity of the HEME tool were calculated using phi. Risk factors for major bleeding were identified using a multivariable Cox proportional hazards model. RESULTS: Overall, 90% of patients experienced a total of 480 bleeds of which 94.8% were minor and 5.2% were major. Inter-rater reliability of the HEME tool was excellent (phi = 0.98, 95% CI: 0.96 to 0.99). A decrease in platelet count and a prolongation of partial thromboplastin time were independent risk factors for major bleeding but neither were renal failure nor prophylactic anticoagulation. Patients with major bleeding received more blood transfusions and had longer ICU stays compared to patients with minor or no bleeding. CONCLUSIONS: Bleeding, although primarily minor, occurred in the majority of ICU patients. One of five patients experienced a major bleed which was associated with abnormal coagulation tests but not with prophylactic anticoagulants. These baseline bleeding rates can inform the design of future clinical trials in critical care that use bleeding as an outcome and HEME is a useful tool to measure bleeding in critically ill patients.

Deep venous thrombosis: clinically silent in the intensive care unit.

PURPOSE: The reliability of clinical signs and the physical examination in the evaluation of deep venous thrombosis (DVT) in the critically ill is unknown. The purpose of this study was to determine the diagnostic properties of clinical examination for signs of DVT in a cohort of medical-surgical intensive care unit (ICU) patients using screening compression ultrasonography as a reference standard. MATERIALS AND METHODS: We prospectively included patients older than 18 years with an expected length of ICU stay of more than 72 hours. Patients underwent bilateral lower limb screening compression ultrasound twice weekly and structured physical examination twice weekly by 2 independent trained research coordinators blinded to the ultrasonography results. We classified patients according to 2 methods: method 1, a DVT Risk Stratification System of 3 categories and method 2, a DVT Risk Score, both of which use the history and physical examination to stratify patients for their risk of DVT. RESULTS: We included 239 patients in our study, 32 of whom had DVT based on the results of their compression ultrasound. We excluded 7 patients with DVT on ICU admission and 2 who did not undergo any structured examinations. We matched controls with cases (9:1) based on duration of ICU stay. Cases and controls were then allocated to low, moderate, and high risk strata for DVT. Using method 1, the area under the receiver operating characteristic curve (AUC) was 0.57 (95% CI, 0.33-0.78, P = .01). Using method 2, the AUC was 0.59 (95% CI, 0.42-0.75, P = .02). An AUC of 1.0 indicates an ideal test, and AUC of 0.50 indicates a test with no diagnostic utility. CONCLUSIONS: The history and physical examination for DVT are not useful in detecting lower limb DVT in the ICU.