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Novel Arm Restraint in the Intensive Care Unit

NCT03621475 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-05-29

Study results available
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Summary

The goal of this pilot is to evaluate a novel restraint device in 8 older mechanically ventilated patients to demonstrate that 1) the revised novel restraint prototype is safe and 2) a future randomized controlled trial (RCT) is feasible.

Conditions

  • Acute Respiratory Failure

Interventions

DEVICE

Novel restraint

Use of a novel arm restraint

Sponsors & Collaborators

  • Healthy Design, LLC

    collaborator UNKNOWN

  • University of Vermont

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2019-04-11
Completion
2019-04-15

Countries

  • United States

Study Locations

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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 NCT03621475 on ClinicalTrials.gov