Feasibility, safety, and patient acceptability of electronic inspiratory muscle training in patients who require prolonged mechanical ventilation in the intensive care unit: A dual-centre observational study.

BACKGROUND: Inspiratory muscle training (IMT) is an intervention that can be used to rehabilitate the respiratory muscle deconditioning experienced by patients with critical illness, requiring prolonged mechanical ventilation. Clinicians are currently using mechanical threshold IMT devices that have limited resistance ranges. OBJECTIVES: The objective of this study was to evaluate the safety, feasibility, and acceptability of using an electronic device to facilitate IMT with participants requiring prolonged mechanical ventilation. METHOD: A dual-centre observational cohort study, with convenience sampling, was conducted at two tertiary intensive care units. Daily training supervised by intensive care unit physiotherapists was completed with the electronic IMT device. A priori definitions for feasibility, safety, and acceptability were determined. Feasibility was defined as more than 80% of planned sessions completed. Safety was defined as no major adverse events and less than 3% minor adverse event rate, and acceptability was evaluated following the acceptability of intervention framework principles. RESULTS: Forty participants completed 197 electronic IMT treatment sessions. Electronic IMT was feasible, with 81% of planned sessions completed. There were 10% minor adverse events and no major adverse events. All the minor adverse events were transient without clinical consequences. All the participants who recalled completing electronic IMT sessions reported that the training was acceptable. Acceptability was demonstrated; over 85% of participants reported that electronic IMT was either helpful or beneficial and that electronic IMT assisted their recovery. CONCLUSION: Electronic IMT is feasible and acceptable to complete with critically ill participants who require prolonged mechanical ventilation. As all minor adverse events were transient without clinical consequences, electronic IMT can be considered a relatively safe intervention with patients who require prolonged mechanical ventilation.

Predictors of acute muscle loss in the intensive care unit: A secondary analysis of an in-bed cycling trial for critically ill patients.

PURPOSE: The purpose of this study was to assist clinicians to identify critically ill patients at greatest risk of acute muscle loss and to analyse the associations between protein intake and exercise on acute muscle loss. MATERIALS AND METHODS: Secondary analysis of a single-centre randomised clinical trial of in-bed cycling using a mixed effects model was undertaken to examine the association between key variables and rectus femoris cross-sectional area (RFCSA). Groups were combined, and key variables for the cohort were modified Nutrition Risk in the Critically Ill (mNUTRIC) scores within the first days following intensive care unit admission, longitudinal RFCSA measurements, percent of daily recommended protein intake, and group allocation (usual care, in-bed cycling). RFCSA ultrasound measurements were taken at baseline and days 3, 7, and 10 to quantify acute muscle loss. All patients received usual care nutritional intake while in the intensive care unit. Patients allocated to the cycling group commenced in-bed cycling once safety criteria were met. RESULTS: Analysis included all 72 participants, of which 69% were male, with a mean (standard deviation) age of 56 (17) years. Patients received a mean (standard deviation) of 59% (26%) of the minimum protein dose recommended for critically ill patients. Mixed-effects model results indicated that patients with higher mNUTRIC scores experienced greater RFCSA loss (estimate = -0.41; 95% confidence interval [CI] = -0.59 to -0.23). RFCSA did not share a statistically significant association with cycling group allocation (estimate = -0.59, 95% CI = -1.53 to 0.34), the percentage of protein requirements received (estimate = -0.48; 95% CI = -1.16 to 0.19), or a combination of cycling group allocation and higher protein intake (estimate = 0.33, 95% CI = -0.76 to 1.43). CONCLUSIONS AND RELEVANCE: We found that a higher mNUTRIC score was associated with greater muscle loss, but we did not observe a relationship between combined protein delivery and in-bed cycling and muscle loss. The low protein doses achieved may have impacted the potential for exercise or nutrition strategies to reduce acute muscle loss. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry (ACTRN 12616000948493).

Comparison of 6-Month Outcomes of Survivors of COVID-19 versus Non-COVID-19 Critical Illness.

Rationale: The outcomes of survivors of critical illness due to coronavirus disease (COVID-19) compared with non-COVID-19 are yet to be established. Objectives: We aimed to investigate new disability at 6 months in mechanically ventilated patients admitted to Australian ICUs with COVID-19 compared with non-COVID-19. Methods: We included critically ill patients with COVID-19 and non-COVID-19 from two prospective observational studies. Patients were eligible if they were adult (age ⩾ 8 yr) and received ⩾24 hours of mechanical ventilation. In addition, patients with COVID-19 were eligible with a positive laboratory PCR test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Measurements and Main Results: Demographic, intervention, and hospital outcome data were obtained from electronic medical records. Survivors were contacted by telephone for functional outcomes with trained outcome assessors using the World Health Organization Disability Assessment Schedule 2.0. Between March 6, 2020, and April 21, 2021, 120 critically ill patients with COVID-19, and between August 2017 and January 2019, 199 critically ill patients without COVID-19, fulfilled the inclusion criteria. Patients with COVID-19 were older (median [interquartile range], 62 [55-71] vs. 58 [44-69] yr; P = 0.019) with a lower Acute Physiology and Chronic Health Evaluation II score (17 [13-20] vs. 19 [15-23]; P = 0.011). Although duration of ventilation was longer in patients with COVID-19 than in those without COVID-19 (12 [5-19] vs. 4.8 [2.3-8.8] d; P < 0.001), 180-day mortality was similar between the groups (39/120 [32.5%] vs. 70/199 [35.2%]; P = 0.715). The incidence of death or new disability at 180 days was similar (58/93 [62.4%] vs. 99/150 [66/0%]; P = 0.583). Conclusions: At 6 months, there was no difference in new disability for patients requiring mechanical ventilation for acute respiratory failure due to COVID-19 compared with non-COVID-19. Clinical trial registered with www.clinicaltrials.gov (NCT04401254).

The perceived barriers and facilitators to implementation of early mobilisation within a multicentre, phase 3 randomised controlled trial: A qualitative process evaluation study.

BACKGROUND: Process evaluation within clinical trials provides an assessment of the study implementation's accuracy and quality to explain causal mechanisms and highlight contextual factors associated with variation in outcomes. OBJECTIVES: This study aimed to identify the barriers and facilitators of implementing early mobilisation (EM) within a trial. METHODS: This is a qualitative process evaluation study within the Trial of Early Activity and Mobilisation (TEAM) phase 3 randomised controlled trial. Semistructured interviews were conducted remotely with multiprofessional clinicians (physiotherapists, medical staff, and nursing staff) involved in the delivery of the TEAM intervention at Australian hospitals participating in the TEAM study. Inductive coding was used to establish themes which were categorised into the Behaviour system involving domains of Capability, Opportunity, and Motivation (COM-B), which allowed barriers and enablers affecting EM to be identified. FINDINGS: Semistructured interviews were conducted in three different states of Australia. There were 16 participants, including 10 physiotherapists, five physicians, and one nurse. The key themes that facilitated EM were mentoring, champions, additional staff, organisation of the environment, cultural changes, communication, and documented safety criteria. In contrast, the main factors that hindered EM were lack of expertise and confidence in delivering EM, heavy sedation, interdisciplinary conflicts, and perceived risks related to EM. CONCLUSION: A wide range of barriers and facilitators that influenced EM within the TEAM study were identified using the COM-B framework. Many of these have been previously identified in the literature; however, participation in the study was viewed positively by multidisciplinary team members.

The impact of COVID-19 critical illness on new disability, functional outcomes and return to work at 6 months: a prospective cohort study.

BACKGROUND: There are few reports of new functional impairment following critical illness from COVID-19. We aimed to describe the incidence of death or new disability, functional impairment and changes in health-related quality of life of patients after COVID-19 critical illness at 6 months. METHODS: In a nationally representative, multicenter, prospective cohort study of COVID-19 critical illness, we determined the prevalence of death or new disability at 6 months, the primary outcome. We measured mortality, new disability and return to work with changes in the World Health Organization Disability Assessment Schedule 2.0 12L (WHODAS) and health status with the EQ5D-5LTM. RESULTS: Of 274 eligible patients, 212 were enrolled from 30 hospitals. The median age was 61 (51-70) years, and 124 (58.5%) patients were male. At 6 months, 43/160 (26.9%) patients died and 42/108 (38.9%) responding survivors reported new disability. Compared to pre-illness, the WHODAS percentage score worsened (mean difference (MD), 10.40% [95% CI 7.06-13.77]; p < 0.001). Thirteen (11.4%) survivors had not returned to work due to poor health. There was a decrease in the EQ-5D-5LTM utility score (MD, - 0.19 [- 0.28 to - 0.10]; p < 0.001). At 6 months, 82 of 115 (71.3%) patients reported persistent symptoms. The independent predictors of death or new disability were higher severity of illness and increased frailty. CONCLUSIONS: At six months after COVID-19 critical illness, death and new disability was substantial. Over a third of survivors had new disability, which was widespread across all areas of functioning. Clinical trial registration NCT04401254 May 26, 2020.

Effect of in-bed cycling on acute muscle wasting in critically ill adults: A randomised clinical trial.

PURPOSE: To examine whether in-bed cycling assists critically ill adults to reduce acute muscle wasting, improve function and improve quality of life following a period of critical illness. MATERIALS AND METHODS: A single-centre, two-group, randomised controlled trial with blinded assessment of the primary outcome was conducted in a tertiary ICU. Critically ill patients expected to be mechanically ventilated for at least 48 h were randomised to 30 min daily in-bed cycling in addition to usual-care physiotherapy (n = 37) or usual-care physiotherapy (n = 37). The primary outcome was muscle atrophy of rectus femoris cross-sectional area (RFCSA) measured by ultrasound at Day 10 following study enrolment. Secondary outcomes included manual muscle strength, handgrip strength, ICU mobility score, six-minute walk test distance and health-related quality of life up to six-months following hospital admission. RESULTS: Analysis included the 72 participants (mean age, 56-years; male, 68%) who completed the study. There were no significant between-group differences in muscle atrophy of RFCSA at Day 10 (mean difference 3.4, 95% CI -6.9% to 13.6%; p = .52), or for secondary outcomes (p-values ranged p = .11 to p = .95). CONCLUSIONS AND RELEVANCE: In-bed cycling did not reduce muscle wasting in critically ill adults, but this study provides useful effect estimates for large-scale clinical trials. TRIAL REGISTRATION: anzctr.org.au Identifier: ACTRN12616000948493.

Acceptability, safety, and feasibility of in-bed cycling with critically ill patients.

BACKGROUND: In-bed cycling is a promising intervention that may assist critically ill patients to maintain muscle mass and improve their trajectory of recovery. The acceptability of in-bed cycling from the different perspectives of patients, clinicians, and families are unknown. In addition, the safety and feasibility of in-bed cycling in an Australian tertiary intensive care unit (ICU) is relatively unknown. OBJECTIVES: The objective of this study was to examine the acceptability, safety, and feasibility of in-bed cycling in an Australian tertiary, adult, mixed medical, surgical, trauma ICU. METHODS: An observational process evaluation was embedded in one arm of a two-arm parallel phase II randomised controlled trial that was conducted in an Australian tertiary ICU. The process evaluation was of the acceptability, safety, and feasibility of passive and active in-bed cycling for participants allocated to the trial intervention group. In-bed cycling acceptability questionnaires were designed through a three-step Delphi process. Questionnaire responses from patients, family members, and clinicians who participated in or observed the intervention during the Critical Care Cycling Study (CYCLIST) were evaluated to determine the acceptability of in-bed cycling. The congruence of responses between respondents was also compared. Safety and feasibility of the in-bed cycling intervention were assessed against predetermined criteria. RESULTS: Acceptability questionnaire responses demonstrated that in-bed cycling was an acceptable intervention from the perspectives of patients, family members, and clinicians. Questionnaire responses were congruent across the respondent groups. Safety was demonstrated with two minor transient adverse events occurring during 276 in-bed cycling sessions (adverse event rate: 0.7%). In-bed cycling sessions were feasible with 276 of 304 (90%) planned sessions conducted. CONCLUSIONS: Acceptability questionnaire responses found that in-bed cycling was regarded as an acceptable intervention to patients, family members, and clinicians. The implementation of in-bed cycling was safe and feasible to complete with critically ill patients during the early stages of their critical illness in an Australian tertiary ICU setting.

Acute cervical spinal cord injury and extubation failure: A systematic review and meta-analysis.

PURPOSE: Respiratory complications are the most significant cause of morbidity and mortality in acute cervical spinal cord injury (CSCI). The prevalence of extubation failure (EF) and factors associated with it are unclear. This research aimed to systematically synthesise and pool literature describing EF and associated risk factors in acute CSCI. METHODS: A systematic review was performed using medical literature analysis and retrieval system online, cummulative index of nursing and allied health literature, excerpta medica dataBASE, and Cochrane library. Articles were screened using the preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines. A proportion meta-analysis was conducted to pool rates of EF. Odds ratios and weighted mean differences were calculated to evaluate risk factors. The R statistical software package was used. RESULTS: Of the 347 articles that were identified, six articles satisfied the inclusion criteria (387 participants). The pooled EF rate was 20.25% (10.13-36.38%). Type of CSCI was the only statistically significant risk factor. The odds of EF occurring were 2.76 [95% confidence interval (CI): 1.14; 6.70] times greater for complete CSCI than for incomplete CSCI. CONCLUSIONS: One in five patients with acute cervical SCI fails extubation. The odds of EF occurring are almost three times greater in complete CSCI. Future research should aim to improve standard data sets and prospective evaluation of adjuvant therapy in the peri-extubation period.

Exercise interventions are delayed in critically ill patients: a cohort study in an Australian tertiary intensive care unit.

OBJECTIVES: This study aims to (i) describe the time to exercise commencement (sitting and upright activities) relative to ICU admission and relative to achievement of initial neurological, respiratory and cardiovascular stability; (ii) examine factors associated with whether sitting and upright activities occurred in ICU; and (iii) examine factors associated with time taken to commence these activities after stability has been achieved. DESIGN: Five-year historical cohort study. SETTING: An Australian tertiary mixed medical, surgical, trauma ICU. PARTICIPANTS: The cohort (n=3222, mean (SD) age 54 (18) years, 67% male) included consecutive ICU patients with length of stay over 48hours admitted to a tertiary ICU who achieved stability. MAIN OUTCOME MEASURES: Time from stability to patients' first completed sitting and upright activities was calculated. Logistic regression (and Cox proportional hazard models) examined whether sitting and upright activities in ICU occurred (and time to these events). INTERVENTIONS: None. RESULTS: For patients who completed exercise interventions (n=1845/3222, 57%), this commenced a median (IQR) 2.3 (1.3-4.4) days after stability for upright activities and 2.7 (1.5-5.7) days for sitting. A large proportion of patients did not complete exercise interventions despite achieving stability (n=1377/3222, 43%). Elective surgical admissions, lower illness severity and older age were associated with completion (and earlier completion) of sitting and upright activity (P<0.01). CONCLUSIONS: Many stable patients did not commence sitting or upright activity in ICU despite known benefits, or commencement was somewhat delayed. Opportunities may exist to improve patient outcomes through timely implementation of exercise-based interventions.

Critical Care Cycling Study (CYCLIST) trial protocol: a randomised controlled trial of usual care plus additional in-bed cycling sessions versus usual care in the critically ill.

INTRODUCTION: In-bed cycling with patients with critical illness has been shown to be safe and feasible, and improves physical function outcomes at hospital discharge. The effects of early in-bed cycling on reducing the rate of skeletal muscle atrophy, and associations with physical and cognitive function are unknown. METHODS AND ANALYSIS: A single-centre randomised controlled trial in a mixed medical-surgical intensive care unit (ICU) will be conducted. Adult patients (n=68) who are expected to be mechanically ventilated for more than 48 hours and remain in ICU for a further 48 hours from recruitment will be randomly allocated into either (1) a usual care group or (2) a group that receives usual care and additional in-bed cycling sessions. The primary outcome is change in rectus femoris cross-sectional area at day 10 in comparison to baseline measured by blinded assessors. Secondary outcome measures include muscle strength, incidence of ICU-acquired weakness, handgrip strength, time to achieve functional milestones (sitting out of bed, walking), Functional Status Score in ICU, ICU Mobility Scale, 6 min walk test 1 week post-ICU discharge, incidence of delirium and quality of life (EuroQol Five Dimensions questionnaire Five Levels scale). Quality of life assessments will be conducted post-ICU admission at day 10, 3 and 6 months after acute hospital discharge. Participants in the intervention group will complete an acceptability of intervention questionnaire. ETHICS AND DISSEMINATION: Appropriate ethical approval from Metro South Health Human Research Ethics Committee has been attained. Results will be published in peer-reviewed publications and presented at scientific conferences to assist planning of future multicentre randomised controlled trials (if indicated) that will test in-bed cycling as an intervention to improve the physical, cognitive and health-related quality of life outcomes of patients with critical illness. TRIAL REGISTRATION NUMBER: This trial has been prospectively registered on the Australian and New Zealand Clinical Trial Registry (ACTRN12616000948493); Pre-results.

Clinicians' perceptions of rationales for rehabilitative exercise in a critical care setting: A cross-sectional study.

BACKGROUND: Rehabilitative exercise for critically ill patients may have many benefits; however, it is unknown what intensive care unit (ICU) clinicians perceive to be important rationale for the implementation of rehabilitative exercise in critical care settings. OBJECTIVE: To identify which rationales for rehabilitative exercise interventions were perceived by ICU clinicians to be important and determine whether perceptions were consistent across nursing, medical and physiotherapy clinicians. METHODS: A cross-sectional study was undertaken among clinicians (nursing, medical, physiotherapy) working in a mixed medical surgical ICU in an Australian metropolitan tertiary hospital. Participants completed a customised web-based questionnaire developed by a clinician working-group. The questionnaire consisted of 11 plausible rationales for commencing rehabilitative exercise in ICUs based on prior literature and their own clinical experiences grouped into 4 over-arching categories (musculoskeletal, respiratory, psychological and facilitation of discharge). Participants rated their perceived importance for each potential rationale on a 5-point Likert scale. RESULTS: Participants (n=76) with a median (interquartile range) 4.8 (1.5, 15.5) years of experience working in ICUs completed the questionnaire. Responses were consistent across professional disciplines. Clinicians rated rehabilitative exercise as either 'very much' or 'somewhat' important for facilitating discharge (n=76, 100%), reducing muscle atrophy (n=76, 100%), increasing muscle strength (n=76, 100%), prevention of contractures (n=73, 96%), reducing the incidence of ICU acquired weakness (n=62, 82%), increasing oxygenation (n=71, 93%), facilitating weaning (n=72, 97%), reducing anxiety (n=60, 80%), reducing depression (n=64, 84%), reducing delirium (n=53, 70%), and increasing mental alertness (n=65, 87%). CONCLUSIONS: Any shortcoming in implementation of rehabilitation exercise is unlikely attributable to a lack of perceived importance by nursing, medical or physiotherapy clinicians who are the most likely clinicians to influence rehabilitation practices in ICUs. It is noteworthy that this study examined self-reported perceptions, not physiological or scientific legitimacy of rationales, or clinician behaviours in practice.

Expert consensus and recommendations on safety criteria for active mobilization of mechanically ventilated critically ill adults.

INTRODUCTION: The aim of this study was to develop consensus recommendations on safety parameters for mobilizing adult, mechanically ventilated, intensive care unit (ICU) patients. METHODS: A systematic literature review was followed by a meeting of 23 multidisciplinary ICU experts to seek consensus regarding the safe mobilization of mechanically ventilated patients. RESULTS: Safety considerations were summarized in four categories: respiratory, cardiovascular, neurological and other. Consensus was achieved on all criteria for safe mobilization, with the exception being levels of vasoactive agents. Intubation via an endotracheal tube was not a contraindication to early mobilization and a fraction of inspired oxygen less than 0.6 with a percutaneous oxygen saturation more than 90% and a respiratory rate less than 30 breaths/minute were considered safe criteria for in- and out-of-bed mobilization if there were no other contraindications. At an international meeting, 94 multidisciplinary ICU clinicians concurred with the proposed recommendations. CONCLUSION: Consensus recommendations regarding safety criteria for mobilization of adult, mechanically ventilated patients in the ICU have the potential to guide ICU rehabilitation whilst minimizing the risk of adverse events.