Jennifer M. Zanni

Rehabilitation therapy and outcomes in acute respiratory failure: an observational pilot project.

PURPOSE The aim of this study was to describe the frequency, physiologic effects, safety, and patient outcomes associated with traditional rehabilitation therapy in patients who require mechanical ventilation. MATERIALS AND METHODS Prospective observational report of consecutive patients ventilated 4 or more days and eligible for rehabilitation in a single medical intensive care unit (ICU) during a 13-week period was conducted. RESULTS Of the 32 patients who met the inclusion criteria, only 21 (66%) received physician orders for evaluation by rehabilitation services (physical and/or occupational therapy). Fifty rehabilitation treatments were provided to 19 patients on a median of 12% of medical ICU days per patient, with deep sedation and unavailability of rehabilitation staff representing major barriers to treatment. Physiologic changes during rehabilitation therapy were minimal. Joint contractures were frequent in the lower extremities and did not improve during hospitalization. In 53% and 79% of initial ICU assessments, muscle weakness was present in upper and lower extremities, respectively, with a decreased prevalence of 19% and 43% at hospital discharge, respectively. New impairments in physical function were common at hospital discharge. CONCLUSIONS This pilot project illustrated important barriers to providing rehabilitation to mechanically ventilated patients in an ICU and impairments in strength, range of motion, and functional outcomes at hospital discharge.

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

IntroductionThe aim of this study was to develop consensus recommendations on safety parameters for mobilizing adult, mechanically ventilated, intensive care unit (ICU) patients.MethodsA systematic literature review was followed by a meeting of 23 multidisciplinary ICU experts to seek consensus regarding the safe mobilization of mechanically ventilated patients.ResultsSafety 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.ConclusionConsensus 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.

Safety of physical therapy interventions in critically ill patients: A single-center prospective evaluation of 1110 intensive care unit admissions ☆

PURPOSE Critical illness survivors commonly have impaired physical functioning. Physical therapy interventions delivered in the intensive care unit can reduce these impairments, but the safety of such interventions within routine clinical practice requires greater investigation. MATERIALS AND METHODS We conducted a prospective observational study of routine physical therapy from July 2009 through December 2011 in the Johns Hopkins Hospital Medical Intensive Care Unit in Baltimore, MD. The incidence of 12 types of physiological abnormalities and potential safety events associated with physical therapy were monitored and evaluated for any additional treatment, cost, or length of stay. RESULTS Of 1787 admissions of at least 24 hours, 1110 (62%) participated in 5267 physical therapy sessions conducted by 10 different physical therapists on 4580 patient-days. A total of 34 (0.6%) sessions had a physiological abnormality or potential safety event, with the most common being arrhythmia (10 occurrences, 0.2%) and mean arterial pressure greater than 140 mm Hg (8 occurrences; 0.2%) and less than 55 mm Hg (5 occurrences; 0.1%). Only 4 occurrences (0.1%) required minimal additional treatment or cost, without additional length of stay. CONCLUSIONS In this large, single-center study, routine care physical therapy interventions were safe for critically ill patients.

Neuromuscular electrical stimulation in mechanically ventilated patients: A randomized, sham-controlled pilot trial with blinded outcome assessment

PURPOSE The purpose of the study is to compare neuromuscular electrical stimulation (NMES) vs sham on leg strength at hospital discharge in mechanically ventilated patients. MATERIALS AND METHODS We conducted a randomized pilot study of NMES vs sham applied to 3 bilateral lower extremity muscle groups for 60 minutes daily in the intensive care unit (ICU). Between June 2008 and March 2013, we enrolled adults who were receiving mechanical ventilation within the first week of ICU stay and who could transfer independently from bed to chair before hospital admission. The primary outcome was lower extremity muscle strength at hospital discharge using Medical Research Council score (maximum, 30). Secondary outcomes at hospital discharge included walking distance and change in lower extremity strength from ICU awakening. Clinicaltrials.gov: NCT00709124. RESULTS We stopped enrollment early after 36 patients due to slow patient accrual and the end of research funding. For NMES vs sham, mean (SD) lower extremity strength was 28 (2) vs 27 (3), P = .072. Among secondary outcomes, NMES vs sham patients had a greater mean (SD) walking distance (514 [389] vs 251 [210] ft, P = .050) and increase in muscle strength (5.7 [5.1] vs 1.8 [2.7], P = .019). CONCLUSIONS In this pilot randomized trial, NMES did not significantly improve leg strength at hospital discharge. Significant improvements in secondary outcomes require investigation in future research.

Safety and feasibility of femoral catheters during physical rehabilitation in the intensive care unit

OBJECTIVE Femoral catheters pose a potential barrier to early rehabilitation in the intensive care unit (ICU) due to concerns, such as catheter removal, local trauma, bleeding, and infection. We prospectively evaluated the feasibility and safety of physical therapy (PT) in ICU patients with femoral catheters. DESIGN, SETTING, AND PATIENTS We evaluated consecutive medical ICU patients who received PT with a femoral venous, arterial, or hemodialysis catheter(s) in situ. MEASUREMENTS AND MAIN RESULTS Of 1074 consecutive patients, 239 (22%) received a femoral catheter (81% venous, 29% arterial, 6% hemodialysis; some patients had >1 catheter). Of those, 101 (42%) received PT interventions, while the catheter was in situ, for a total of 253 sessions over 210 medical ICU (MICU) days. On these 210 MICU days, the highest daily activity level achieved was 49 (23%) standing or walking, 57 (27%) sitting, 25 (12%) supine cycle ergometry, and 79 (38%) in-bed exercises. During 253 PT sessions, there were no catheter-related adverse events giving a 0% event rate (95% upper confidence limit of 2.1% for venous catheters). CONCLUSIONS Physical therapy interventions in MICU patients with in situ femoral catheters appear to be feasible and safe. The presence of a femoral catheter should not automatically restrict ICU patients to bed rest.

Physical Rehabilitation of Patients in the Intensive Care Unit Requiring Extracorporeal Membrane Oxygenation: A Small Case Series

Background and Purpose Neuromuscular weakness and impaired physical function are common and long-lasting complications experienced by intensive care unit (ICU) survivors. There is growing evidence that implementing rehabilitation therapy shortly after ICU admission improves physical function and reduces health care utilization. Recently, there is increasing interest and utilization of extracorporeal membrane oxygenation (ECMO) to support patients with severe respiratory failure. Patients receiving ECMO are at great risk for significant physical impairments and pose unique challenges for delivering rehabilitation therapy. Consequently, there is a need for innovative examples of safely and feasibly delivering active rehabilitation to these patients. Case Description This case report describes 3 patients with respiratory failure requiring ECMO who received physical rehabilitation to illustrate and discuss relevant feasibility and safety issues. Outcomes In case 1, sedation and femoral cannulation limited rehabilitation therapy while on ECMO. In the 2 subsequent cases, minimizing sedation and utilizing a single bicaval dual lumen ECMO cannula placed in the internal jugular vein allowed patients to be alert and participate in active physical therapy while on ECMO, illustrating feasible rehabilitation techniques for these patients. Discussion Although greater experience is needed to more fully evaluate the safety of rehabilitation on ECMO, these initial cases are encouraging. We recommend systematically and prospectively tracking safety events and patient outcomes during rehabilitation on ECMO to provide greater evidence in this area.

Neuromuscular Electrical Stimulation for Intensive Care Unit–Acquired Weakness: Protocol and Methodological Implications for a Randomized, Sham-Controlled, Phase II Trial

Background As the population ages and critical care advances, a growing number of survivors of critical illness will be at risk for intensive care unit (ICU)–acquired weakness. Bed rest, which is common in the ICU, causes adverse effects, including muscle weakness. Consequently, patients need ICU-based interventions focused on the muscular system. Although emerging evidence supports the benefits of early rehabilitation during mechanical ventilation, additional therapies may be beneficial. Neuromuscular electrical stimulation (NMES), which can provide some muscular activity even very early during critical illness, is a promising modality for patients in the ICU. Objective The objectives of this article are to discuss the implications of bed rest for patients with critical illness, summarize recent studies of early rehabilitation and NMES in the ICU, and describe a protocol for a randomized, phase II pilot study of NMES in patients receiving mechanical ventilation. Design The study was a randomized, sham-controlled, concealed, phase II pilot study with caregivers and outcome assessors blinded to the treatment allocation. Setting The study setting will be a medical ICU. Participants The study participants will be patients who are receiving mechanical ventilation for 1 day or more, who are expected to stay in the ICU for an additional 2 days or more, and who meet no exclusion criteria. Intervention The intervention will be NMES (versus a sham [control] intervention) applied to the quadriceps, tibialis anterior, and gastrocnemius muscles for 60 minutes per day. Measurements Lower-extremity muscle strength at hospital discharge will be the primary outcome measure. Limitations Muscle strength is a surrogate measure, not a patient-centered outcome. The assessments will not include laboratory, genetic, or histological measures aimed at a mechanistic understanding of NMES. The optimal duration or dose of NMES is unclear. Conclusions If NMES is beneficial, the results of the study will help advance research aimed at reducing the burden of muscular weakness and physical disability in survivors of critical illness.

The ICU Mobility Scale Has Construct and Predictive Validity and Is Responsive. A Multicenter Observational Study

RATIONALE The ICU Mobility Scale (IMS) is a measure of mobility milestones in critically ill patients. OBJECTIVES This study aimed to determine the validity and responsiveness of the IMS from a prospective cohort study of adults admitted to the intensive care unit (ICU). METHODS Construct and predictive validity were assessed by comparing IMS values at ICU discharge in 192 patients to other variables using Spearman rank correlation coefficient, Mann-Whitney U tests, and logistic regression. Responsiveness was assessed using change over time, effect size, floor and ceiling effects, and percentage of patients showing change. MEASUREMENTS AND MAIN RESULTS The IMS at ICU discharge demonstrated a moderate correlation with muscle strength (r = 0.64, P < 0.001). There was a significant difference between the IMS at ICU discharge in patients with ICU-acquired weakness (median, 4.0; interquartile range, 3.0-5.0) compared with patients without (median, 8.0; interquartile range, 5.0-8.0; P < 0.001). Increasing IMS values at ICU discharge were associated with survival to 90 days (odds ratio [OR], 1.38; 95% confidence interval [CI], 1.14-1.66) and discharge home (OR, 1.16; 95% CI, 1.02-1.32) but not with return to work at 6 months (OR, 1.09; 95% CI, 0.92-1.28). The IMS was responsive with a significant change from study enrollment to ICU discharge (d = 0.8, P < 0.001), with IMS values increasing in 86% of survivors during ICU admission. No substantial floor (14% scored 0) or ceiling (4% scored 10) effects were present at ICU discharge. CONCLUSIONS Our findings support the validity and responsiveness of the IMS as a measure of mobility in the ICU.

A Quality Improvement Project Sustainably Decreased Time to Onset of Active Physical Therapy Intervention in Patients with Acute Lung Injury

RATIONALE Rehabilitation started early during an intensive care unit (ICU) stay is associated with improved outcomes and is the basis for many quality improvement (QI) projects showing important changes in practice. However, little evidence exists regarding whether such changes are sustainable in real-world practice. OBJECTIVES To evaluate the sustained effect of a quality improvement project on the timing of initiation of active physical therapy intervention in patients with acute lung injury (ALI). METHODS This was a pre-post evaluation using prospectively collected data involving consecutive patients with ALI admitted pre-quality improvement (October 2004-April 2007, n = 120) versus post-quality improvement (July 2009-July 2012, n = 123) from a single medical ICU. MEASUREMENTS AND MAIN RESULTS The primary outcome was time to first active physical therapy intervention, defined as strengthening, mobility, or cycle ergometry exercises. Among ICU survivors, more patients in the post-quality improvement versus pre-quality improvement group received physical therapy in the ICU (89% vs. 24%, P < 0.001) and were able to stand, transfer, or ambulate during physical therapy in the ICU (64% vs. 7%, P < 0.001). Among all patients in the post-quality improvement versus pre-quality improvement group, there was a shorter median (interquartile range) time to first physical therapy (4 [2, 6] vs. 11 d [6, 29], P < 0.001) and a greater median (interquartile range) proportion of ICU days with physical therapy after initiation (50% [33, 67%] vs. 18% [4, 47%], P = 0.003). In multivariable regression analysis, the post-quality improvement period was associated with shorter time to physical therapy (adjusted hazard ratio [95% confidence interval], 8.38 [4.98, 14.11], P < 0.001), with this association significant for each of the 5 years during the post-quality improvement period. The following variables were independently associated with a longer time to physical therapy: higher Sequential Organ Failure Assessment score (0.93 [0.89, 0.97]), higher FiO2 (0.86 [0.75, 0.99] for each 10% increase), use of an opioid infusion (0.47 [0.25, 0.89]), and deep sedation (0.24 [0.12, 0.46]). CONCLUSIONS In this single-site, pre-post analysis of patients with ALI, an early rehabilitation quality improvement project was independently associated with a substantial decrease in the time to initiation of active physical therapy intervention that was sustained over 5 years. Over the entire pre-post period, severity of illness and sedation were independently associated with a longer time to initiation of active physical therapy intervention in the ICU.

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