Phase I pilot safety and feasibility of a novel restraint device for critically ill patients requiring mechanical ventilation.

Background: Mechanically ventilated Intensive Care Unit (ICU) patients often require wrist restraints, contributing to immobility and agitation, over-sedation, and delirium. The Exersides® Refraint® (Healthy Design, LLC), a novel restraint alternative, may be safe and facilitate greater mobility than traditional restraints. Objective: This National Institutes of Health Small Business Technology Transfer (STTR) Program Grant-funded single-site Phase I feasibility study evaluated Exersides® safety and feasibility in anticipation of a multi-site Phase II randomized controlled trial (RCT). Methods: In two academic ICUs, mechanically ventilated adults ⩾25 years old who were non-comatose, required restraints and had an expected stay of ⩾2 days were enrolled to wear Exersides® and traditional wrist restraints for 4 h on day 1, in a randomized order, and in the reverse order on day 2. Main outcomes were Exersides® safety (i.e., patient/clinician lacerations/injuries), feasibility (i.e., ⩾90% of required data collected), and patient/family/clinician feedback. Results: Eight patients were enrolled; one no longer required restraints at initiation, yielding seven subjects (median [interquartile range (IQR)] age 65 [55, 70] years, 86% men). All seven wore Exersides®, averaging (SD) 2.5 (1.0) hours per session, with no safety events reported. Across restraint time periods, 92% and 100% of Richmond Agitation-Sedation Scale (RASS) and wrist actigraphy data, respectively, were collected. Feedback was positive (more movement and comfortable than traditional restraints) and constructive (bulky, intimidating to apply). Conclusions: This pilot study provided key safety and feasibility data for a Phase II RCT evaluating Exersides® versus traditional wrist restraints. Feedback motivated minor device modifications before RCT initiation.

Evolution of Investigating Informed Assent Discussions about CPR in Seriously Ill Patients.

CONTEXT: Outcomes after cardiopulmonary resuscitation (CPR) remain poor. We have spent 10 years investigating an "informed assent" (IA) approach to discussing CPR with chronically ill patients/families. IA is a discussion framework whereby patients extremely unlikely to benefit from CPR are informed that unless they disagree, CPR will not be performed because it will not help achieve their goals, thus removing the burden of decision-making from the patient/family, while they retain an opportunity to disagree. OBJECTIVES: Determine the acceptability and efficacy of IA discussions about CPR with older chronically ill patients/families. METHODS: This multi-site research occurred in three stages. Stage I determined acceptability of the intervention through focus groups of patients with advanced COPD or malignancy, family members, and physicians. Stage II was an ambulatory pilot randomized controlled trial (RCT) of the IA discussion. Stage III is an ongoing phase 2 RCT of IA versus attention control in in patients with advanced chronic illness. RESULTS: Our qualitative work found the IA approach was acceptable to most patients, families, and physicians. The pilot RCT demonstrated feasibility and showed an increase in participants in the intervention group changing from "full code" to "do not resuscitate" within two weeks after the intervention. However, Stages I and II found that IA is best suited to inpatients. Our phase 2 RCT in older hospitalized seriously ill patients is ongoing; results are pending. CONCLUSIONS: IA is a feasible and reasonable approach to CPR discussions in selected patient populations.

Vitamin D Supplementation in Mechanically Ventilated Patients in the Medical Intensive Care Unit.

BACKGROUND: The utility of vitamin D (VITD) supplementation during critical illness and whether it may alter outcomes, including mortality and ventilator-free days, is unclear. We performed a retrospective cohort study in a generalizable population to investigate this question. METHODS: We included all mechanically ventilated adults admitted to the medical intensive care unit (ICU) service at a tertiary center from 2009 to 2012 who were in the ICU for at least 72 hours. Patients were grouped as having received or not received VITD at any time during the first 7 days of their ICU stay, and we adjusted for the following covariates with multivariable analyses: simplified acute physiology score, age, gender, admission diagnosis, race/ethnicity, admission season, admission day of the week, and VITD supplementation prior to admission. RESULTS: Among the 610 included patients, 281 received VITD, and 329 did not. There were no differences in outcomes between these groups. However, we did find significantly more ventilator-free days (21.0±2.6 [adjusted mean days±standard error] vs 17.6±2.4, P=0.04) and ICU-free days (18.5±2.5 vs 16.3±2.3, P=0.03) in patients who were taking VITD prior to admission (n=91) vs those who were not (n=519). No patients who were taking VITD before admission died vs 34.5% of those who were not (estimated odds ratio=4.9×10-7 , 95% CI=3.1×10-7 to 7.5×10-7 , P<0.0001). CONCLUSION: These results suggest that VITD supplementation during critical illness may not provide benefit and that further research investigating potential supplementation in ambulatory patients at high risk of ICU admission (eg, severe underlying chronic disease) is warranted.