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Behavioural Intervention

Traditional restraints first for Encephalopathy

N/A
Waitlist Available
Led By Renee Stapleton, MD, PhD
Research Sponsored by University of Vermont
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, every 60 minutes on study days 1-2, every 4 hours on study days 3-6
Awards & highlights

Summary

This trial looks at whether a new arm restraint is better than the usual soft wrist restraints for older patients in the ICU.

Eligible Conditions
  • Encephalopathy
  • Acute Respiratory Distress Syndrome
  • Critical Illness
  • Acute Respiratory Failure
  • Sepsis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, every 60 minutes on study days 1-2, every 4 hours on study days 3-6
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, every 60 minutes on study days 1-2, every 4 hours on study days 3-6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mobility assessed by actigraphy
Secondary study objectives
Average cumulative dose of analgesic medications
Average cumulative dose of antipsychotic medications
Average cumulative dose of sedative medications
+2 more
Other study objectives
Acceptability of novel restraint (nurses, family, physicians, and patients when able)
Satisfaction with novel restraint (nurses, family, physicians, and patients when able)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Traditional restraints firstExperimental Treatment1 Intervention
Patients in this arm will wear soft wrist restraints during hours 1-4 on Day 1; they will then be switched to the novel Exersides restraint during hours 5-8. On Day 2, patients in this arm will will wear Exersides during hours 1-4, and soft wrist restraints during hours 5-8. They will then wear soft wrist restraints during study days 3-6.
Group II: Exersides restraints firstExperimental Treatment1 Intervention
Patients in this arm will wear the novel Exersides restraint during hours 1-4 on Day 1, then switched to soft wrist restrains during hours 5-8. On Day 2, patients in this arm will will wear soft wrist restraints during hours 1-4, and Exersides during hours 5-8. They will then wear Exersides during study days 3-6.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exersides
2019
N/A
~60

Find a Location

Who is running the clinical trial?

Healthy Design, LLCUNKNOWN
1 Previous Clinical Trials
8 Total Patients Enrolled
Johns Hopkins UniversityOTHER
2,307 Previous Clinical Trials
14,861,851 Total Patients Enrolled
University of VermontLead Sponsor
274 Previous Clinical Trials
3,743,698 Total Patients Enrolled
~10 spots leftby Sep 2025
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