Elsevier

Journal of Critical Care

Volume 31, Issue 1, February 2016, Pages 31-35
Journal of Critical Care

Predictors/Outcomes
Prevalence, risk factors, and outcomes associated with physical restraint use in mechanically ventilated adults,☆☆,

https://doi.org/10.1016/j.jcrc.2015.09.011Get rights and content

Abstract

Purpose

The purpose was to describe characteristics and outcomes of restrained and nonrestrained patients enrolled in a randomized trial of protocolized sedation compared with protocolized sedation plus daily sedation interruption and to identify patient and treatment factors associated with physical restraint.

Methods

This was a post hoc secondary analysis using Cox proportional hazards modeling adjusted for center- and time-varying covariates to evaluate predictors of restraint use.

Results

A total of 328 (76%) of 430 patients were restrained for a median of 4 days. Restrained patients received higher daily doses of benzodiazepines (105 vs 41 mg midazolam equivalent, P < .0001) and opioids (1524 vs 919 μg fentanyl equivalents, P < .0001), more days of infusions (benzodiazepines 6 vs 4, P < .0001; opioids 7 vs 5, P = .02), and more daily benzodiazepine boluses (0.2 vs 0.1, P < .0001). More restrained patients received haloperidol (23% vs 12%, P = .02) and atypical antipsychotics (17% vs 4%, P = .003). More restrained patients experienced unintentional device removal (26% vs 3%, P < .001) and required reintubation (8% vs 1%, P = .01). In the multivariable analysis, alcohol use was associated with decreased risk of restraint (hazard ratio, 0.22; 95% confidence interval, 0.08-0.58).

Conclusions

Physical restraint was common in mechanically ventilated adults managed with a sedation protocol. Restrained patients received more opioids and benzodiazepines. Except for alcohol use, patient characteristics and treatment factors did not predict restraint use.

Introduction

Physical restraints are used to promote the safety of critically ill patients; however, their use has been associated with adverse outcomes including injury to restrained limbs [1], delirium [2], [3], [4], unplanned extubation [5], [6], and an increased prevalence of posttraumatic stress symptoms in intensive care unit (ICU) survivors [7], [8]. Although physical restraints are often applied to prevent patient-initiated device removal, several studies indicate high failure rates [9]. One large multicenter prevalence study conducted in the United States found that 44% of patients were physically restrained at the time of device removal [10]. Given the recognized adverse physical and psychological patient consequences of physical restraints and their lack of efficacy in preventing device removal, professional society guidelines, government legislation, and hospital accreditation standards advocate that physical restraint use be minimized across all health care settings [11], [12], [13].

Physical restraint use varies substantially across countries from 0% to 100% [14] and even among hospitals in the same country [15]. In a 2013 survey of 121 French ICUs, restraints were used at least once during mechanical ventilation in more than 50% of patients; and in 65% of these ICUs, restraints were applied for more than 50% of mechanical ventilation days [16]. A prospective observational study (I-CAN-SLEAP) conducted in 2008/2009 in 51 Canadian ICUs found that 53% of 711 mechanically ventilated patients were physically restrained for an average of 4 days [17]. More recently, the SLEAP trial, a prospective randomized trial conducted in 16 tertiary ICUs in Canada and the United States comparing protocolized sedation (control group) with protocolized sedation plus daily interruption (DI) (interruption group), found that most (328/430, 76%) patients had physical restraints applied at least once during their ICU admission [18]. In this study cohort, overall mean Sedation-Agitation Scale (SAS) scores were 3.3 vs 3.2 in the interruption and control groups, respectively, reflecting appropriate sedation.

The frequent use of physical restraints identified in the SLEAP trial was unexpected. Therefore, we conducted a secondary analysis to describe characteristics and outcomes of restrained and nonrestrained patients and to identify associations between patient and treatment factors and restraint application.

Section snippets

Methods

We performed a post hoc secondary analysis of SLEAP trial data to identify factors associated with restraint use. The SLEAP trial methods have been published previously [18]. The trial was conducted in 16 tertiary ICUs in Canada and the United States from January 2008 until July 2011 following local institutional review board approvals.

Results

We identified that 328 (76%) of 430 randomized patients were restrained for a median of 4 (IQR, 1-7) days while mechanically ventilated. The median day of restraint initiation was study day 1 (IQR, 1-1). There was no difference in the use of restraints on day vs night shifts (both median of 3 shifts) or in the interruption vs control groups. Sixteen percent of the 328 restrained patients remained restrained after extubation. Baseline characteristics were similar between the restrained and

Discussion

In this secondary analysis of SLEAP study data, we found that physical restraint use was common and that restraints were applied for prolonged periods with a similar pattern of restraint use during the day and night. Compared with nonrestrained patients, restrained patients were less severely ill, less likely to be comatose during their ICU stay, but more likely to experience unintentional device removal. Indeed, 82% of device removals occurred while the patient was restrained. Restrained

Conclusion

Physical restraints were commonly used in mechanically ventilated patients managed using a sedation protocol, were applied for prolonged periods, and had similar patterns of use during the day and night, suggesting that they may be overused during mechanical ventilation. Compared with nonrestrained patients, physically restrained patients experienced more patient-initiated device removal, received higher doses of benzodiazepines and opioids for more days, experienced more delirium, and received

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    Conflict of interest: The authors have no conflicts of interest to declare.

    ☆☆

    ClinicalTrials.gov NCT 00675363.

    Funding: The SLEAP trial was funded by the Canadian Institutes of Health Research. The secondary analysis of restraint use was funded by the Canadian Association of Critical Care Nurses and a Sigma Theta Tau International Lambda Pi-At-Large Research Seed Grant and the Mount Sinai Hospital Department of Medicine.

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