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Novel Arm Restraint For Critically Ill Patients To Reduce Immobility, Sedation, Agitation and Cognitive Impairment

NCT04067622 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2022-03-10

No results posted yet for this study

Summary

This study evaluates a novel arm restraint compared with traditional soft wrist restraints in older critically ill patients. The primary outcome is upper extremity mobility measured by actigraphy, and secondary outcomes include sedation, agitation, satisfaction, and acceptability.

Conditions

  • Acute Respiratory Failure
  • Encephalopathy
  • ARDS
  • Sepsis
  • Critical Illness

Interventions

DEVICE

Exersides

A novel arm restraint which permits arm mobility but prohibits hands from reaching oral/nasal endotracheal and feeding tubes or intravenous lines.

Sponsors & Collaborators

Principal Investigators

  • Renee Stapleton, MD, PhD · University of Vermont

  • Dale Needham, MD, PhD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2021-12-24
Completion
2021-12-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04067622 on ClinicalTrials.gov