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.

Early mobilization of critically ill adults: a survey of knowledge, perceptions and practices of Canadian physicians and physiotherapists.

BACKGROUND: The promotion of early mobilization following critical illness is tempered by national reports of patient and institutional barriers to this approach. We carried out a survey to assess current knowledge, perceptions and practices of Canadian physicians and physiotherapists with respect to acquired weakness and early mobilization in adults in the intensive care unit (ICU). METHODS: We conducted a cross-sectional, self-administered postal survey among critical care physicians and physiotherapists in all 46 academic ICUs in Canada in 2011-2012. To identify all physicians and physiotherapists working in the ICUs, we contacted division heads and senior physiotherapists by telephone or email. We designed, tested and administered a questionnaire with the following domains: knowledge of ICU-acquired weakness and early mobilization; personal views of, perceived barriers to and adequacy of technical skills for early mobilization; assessments for initiation of early mobilization and permissible activity levels by patient physiologic characteristics, diagnoses and therapies; staffing issues; and sedation practices. RESULTS: The overall response rate was 71.3% (311/436); it was 64.2% (194/302) among physicians and 87.3% (117/134) among physiotherapists. A total of 214 respondents (68.8%) underestimated the incidence of ICU-acquired weakness in the general medical-surgical ICU population, and 186 (59.8%) stated they had insufficient knowledge or skills to mobilize patients receiving mechanical ventilation. Excessive sedation, medical instability, limited staffing, safety concerns, insufficient guidelines and insufficient equipment were common perceived barriers to early mobilization. INTERPRETATION: Physicians and physiotherapists in the ICU underestimated the incidence of ICU-acquired weakness and felt inadequately trained to mobilize patients receiving mechanical ventilation. We identified multiple modifiable barriers to early mobilization at the institutional, health care provider and patient levels that need to be addressed when designing mobilization programs for critically ill adults.

CYCLE pilot: a protocol for a pilot randomised study of early cycle ergometry versus routine physiotherapy in mechanically ventilated patients.

INTRODUCTION: Early exercise with in-bed cycling as part of an intensive care unit (ICU) rehabilitation programme has the potential to improve physical and functional outcomes following critical illness. The objective of this study is to determine the feasibility of enrolling adults in a multicentre pilot randomised clinical trial (RCT) of early in-bed cycling versus routine physiotherapy to inform a larger RCT. METHODS AND ANALYSIS: 60-patient parallel group pilot RCT in 7 Canadian medical-surgical ICUs. We will include all previously ambulatory adult patients within the first 0-4 days of mechanical ventilation, without exclusion criteria. After informed consent, patients will be randomised using a web-based, centralised electronic system, to 30 min of in-bed leg cycling in addition to routine physiotherapy, 5 days per week, for the duration of their ICU stay (28 days maximum) or routine physiotherapy alone. We will measure patients' muscle strength (Medical Research Council Sum Score, quadriceps force) and function (Physical Function in ICU Test (scored), 30 s sit-to-stand, 2 min walk test) at ICU awakening, ICU discharge and hospital discharge. Our 4 feasibility outcomes are: (1) patient accrual of 1-2 patients per month per centre, (2) protocol violation rate <20%, (3) outcome measure ascertainment >80% at the 3 time points and (4) blinded outcomes ascertainment >80% at hospital discharge. Hospital outcome assessors are blinded to group assignment, whereas participants, ICU physiotherapists, ICU caregivers, research coordinators and ICU outcome assessors are not blinded to group assignment. We will analyse feasibility outcomes with descriptive statistics. ETHICS AND DISSEMINATION: Each participating centre will obtain local ethics approval, and results of the study will be published to inform the design and conduct of a future multicentre RCT of in-bed cycling to improve physical outcomes in ICU survivors. TRIAL REGISTRATION NUMBER: NCT02377830; Pre-results.

Higher versus lower blood pressure targets for vasopressor therapy in shock: a multicentre pilot randomized controlled trial.

PURPOSE: In shock, hypotension may contribute to inadequate oxygen delivery, organ failure and death. We conducted the Optimal Vasopressor Titration (OVATION) pilot trial to inform the design of a larger trial examining the effect of lower versus higher mean arterial pressure (MAP) targets for vasopressor therapy in shock. METHODS: We randomly assigned critically ill patients who were presumed to suffer from vasodilatory shock regardless of admission diagnosis to a lower (60-65 mmHg) versus a higher (75-80 mmHg) MAP target. The primary objective was to measure the separation in MAP between groups. We also recorded days with protocol deviations, enrolment rate, cardiac arrhythmias and mortality for prespecified subgroups. RESULTS: A total of 118 patients were enrolled from 11 centres (2.3 patients/site/month of screening). The between-group separation in MAP was 9 mmHg (95% CI 7-11). In the lower and higher MAP groups, we observed deviations on 12 versus 8% of all days on vasopressors (p = 0.059). Risks of cardiac arrhythmias (20 versus 36%, p = 0.07) and hospital mortality (30 versus 33%, p = 0.84) were not different between lower and higher MAP arms. Among patients aged 75 years or older, a lower MAP target was associated with reduced hospital mortality (13 versus 60%, p = 0.03) but not in younger patients. CONCLUSIONS: This pilot study supports the feasibility of a large trial comparing lower versus higher MAP targets for shock. Further research may help delineate the reasons for vasopressor dosing in excess of prescribed targets and how individual patient characteristics modify the response to vasopressor therapy.

Corticosteroid use in the intensive care unit: a survey of intensivists.

OBJECTIVE: The efficacy of systemic corticosteroids in many critical illnesses remains uncertain. Our primary objective was to survey intensivists in North America about their perceived use of corticosteroids in clinical practice. DESIGN: Self-administered paper survey. POPULATION: Intensivists in academic hospitals with clinical trial expertise in critical illness. MEASUREMENTS: We generated questionnaire items in focus groups and refined them after assessments of clinical sensibility and test-retest reliability and pilot testing. We administered the survey to experienced intensivists practicing in selected North American centres actively enrolling patients in the multicentre Oscillation for ARDS Treated Early (OSCILLATE) Trial (ISRCTN87124254). Respondents used a four-point scale to grade how frequently they would administer corticosteroids in 14 clinical settings. They also reported their opinions on 16 potential near-absolute indications or contraindications for the use of corticosteroids. MAIN RESULTS: Our response rate was 82% (103/125). Respondents were general internists (50%), respirologists (22%), anesthesiologists (21%), and surgeons (7%) who practiced in mixed medical-surgical units. A majority of respondents reported almost always prescribing corticosteroids in the setting of significant bronchospasm in a mechanically ventilated patient (94%), recent corticosteroid use and low blood pressure (93%), and vasopressor-refractory septic shock (52%). Although more than half of respondents stated they would almost never prescribe corticosteroids in severe community-acquired pneumonia (81%), acute lung injury (ALI, 76%), acute respiratory distress syndrome (ARDS, 65%), and severe ARDS (51%), variability increased with severity of acute lung injury. Near-absolute indications selected by most respondents included known adrenal insufficiency (99%) and suspicion of cryptogenic organizing pneumonia (89%), connective tissue disease (85%), or other potentially corticosteroid-responsive illnesses (85%). CONCLUSIONS: Respondents reported rarely prescribing corticosteroids for ALI, but accepted them for bronchospasm, suspected adrenal insufficiency due to previous corticosteroid use, and vasopressor-refractory septic shock. These competing indications will complicate the design and interpretation of any future large-scale trial of corticosteroids in critical illness.

Early mobilization in critically ill children: a survey of Canadian practice.

OBJECTIVES: While early mobilization is safe and enhances functional recovery in critically ill adults, rehabilitation practices in critically ill children are not well characterized. The objective of this study was to evaluate the knowledge, perceptions, and stated practices of early mobilization among physicians and physiotherapists practicing in Canadian pediatric critical care units. DESIGN AND MEASUREMENTS: A self-administered survey was mailed to 102 physicians and 35 physiotherapists. Survey domains included barriers to early mobilization, the timing, nature and thresholds for rehabilitation, and staffing workload. We assessed for associations using chi-square tests. MAIN RESULTS: The overall response rate was 64.2% (88 of 137), representing 59.8% (61 of 102) physicians and 77.1% (27 of 35) physiotherapists, respectively. Key institutional barriers to early mobilization included a lack of practice guidelines (75.4% physician, 48.1% physiotherapist respondents; p = 0.01) and the need for physician orders prior to initiating physiotherapy (26.2% physician vs 55.6% physiotherapist, p = 0.008). Only 3.4% of respondents reported having local guidelines for early mobilization. Conflicting perceptions regarding the clinical thresholds for early mobilization and the safety of early mobilization were the most commonly reported patient-level barriers. Increasing illness severity was associated with decreased clinician comfort with early mobilization. Respiratory physiotherapy and passive range of motion were the most frequently applied rehabilitation interventions (77.8%), while pregait physiotherapy and ambulation were only sometimes or infrequently (70.4%) used. The type and extent of physiotherapy varied depending on the time of day and week. CONCLUSIONS: There are numerous perceived institutional, patient- and provider-level barriers to early mobilization in Canadian pediatric critical care units, and diverse opinions on the appropriateness of early mobilization. Limited awareness of existing literature and the lack of practice guidelines on early mobilization are not surprising in light of the paucity of pediatric-specific evidence. These results strongly support the need for further research, evaluating the feasibility, safety, and efficacy of early mobilization in critically ill children.

Pulmonary artery catheters: evolving rates and reasons for use.

OBJECTIVE: Randomized trials have demonstrated risks and failed to establish a clear benefit for the use of the pulmonary artery catheter. We assessed rates of pulmonary artery catheter use in multiple centers over 5 yrs, variables associated with their use, and how these variables changed over time (2002-2006). DESIGN: A multicenter longitudinal study using the Hamilton Regional Critical Care Database. A two-level multiple logistic regression analysis was used to determine significant variables associated with pulmonary artery catheter use and whether these varied over time. SETTING: Academic intensive care units in Hamilton, Canada. PATIENTS: We identified patients from five intensive care units who received a pulmonary artery catheter within the first 2 days of intensive care unit admission. INTERVENTIONS: Pulmonary artery catheter use over a 5-yr period. MEASUREMENTS AND MAIN RESULTS: Among 15,006 patients, 1,921 (12.8%) had a pulmonary artery catheter. Adjusted rates of pulmonary artery catheter use decreased from 16.4% to 6.5% over 5 yrs. Determinants of pulmonary artery catheter use included Acute Physiology and Chronic Health Evaluation II score (odds ratio [OR], 1.05; confidence interval [CI], 1.04-1.06; p < .0001), elective surgical status (OR, 2.82; CI, 2.29-3.48; p < .0001), postabdominal aortic aneurysm repair (OR, 10.91; CI, 8.24-14.45; p < .0001), cardiogenic shock (OR, 5.31; CI, 3.35-8.42; p < .0001), sepsis (OR, 2.83; CI, 1.94-4.13; p < .0001), vasoactive infusion use (OR, 4.04; CI, 3.47-4.71; p < .0001), and mechanical ventilation (OR, 2.21; CI, 1.86-2.63; p < .0001). Physician's base specialty and local intensive care unit were also associated with pulmonary artery catheter use (p < .0001). The determinants of pulmonary artery catheter use did not change over time. CONCLUSIONS: We observed a >50% reduction in the rate of pulmonary artery catheter use over 5 yrs. Patient factors predicting pulmonary artery catheter use were illness severity, specific diagnoses, and the need for advanced life support. Nonpatient factors predicting pulmonary artery catheter use were intensive care unit and the attending physician's base specialty.