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NCT04067622 · ClinicalTrials.gov registry record · NA
Novel Arm Restraint For Critically Ill Patients To Reduce Immobility, Sedation, Agitation and Cognitive Impairment
A NA study of Critical Illness and Sepsis, sponsored by University of Vermont.
- Completed
- Registry status
- NA
- Development phase
- 58
- Enrollment target
- 3
- Study locations
NCT04067622: Completed NA study of Critical Illness and Sepsis, sponsored by University of Vermont.
NCT04067622 is a NA study of Critical Illness and Sepsis that has completed, run by University of Vermont. The registered enrollment target is 58 participants, below the 3,138-participant average among 91 other Critical Illness trials with a reported enrollment target (98% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04067622, a NA study of Critical Illness and Sepsis, has completed, sponsored by University of Vermont.
- COMPLETED
- Registry status
- NA
- Development phase
- 58 participants
- Enrollment target
- 3
- Study locations
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.
Primary Outcome
Upper extremity mobility will be evaluated by actigraphy. The Philips Respironics Spectrum Plus® actigraph is a commercially-available actigraphy device weighing 16 grams. It contains a battery-powered activity monitor and uses a highly sensitive accelerometer to monitor the occurrence and degree of motion. Only patients who wear both the novel restraint and traditional soft wrist restraints for at least 4 hours each will be included in the primary analysis.
Conditions Studied
Interventions
- DEVICE Exersides
Study Locations (3)
California
- University of California San Diego - San Diego
Maryland
- Johns Hopkins University - Baltimore
Vermont
- University of Vermont - Burlington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2019-09-01 |
| Est. Completion | 2021-12-28 |
| Phase | NA |
What the finished NCT04067622 record still lists
NCT04067622 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 3,138-participant average among 91 other Critical Illness trials with a reported enrollment target (98% lower).
The record links to 5 conditions, with Critical Illness appearing as the primary indexed condition, and to 1 intervention - of which Exersides is the first listed.
NCT04067622 reports a single indexed study location in California, Maryland, Vermont.
Frequently Asked Questions
What is clinical trial NCT04067622 about?
NCT04067622 is a clinical study titled "Novel Arm Restraint For Critically Ill Patients To Reduce Immobility, Sedation, Agitation and Cognitive Impairment". 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.
What is the current status of trial NCT04067622?
This trial is currently completed. It is a NA study. The enrollment target is 58 participants. The study started on 2019-09-01. Estimated completion is 2021-12-28.
What conditions does trial NCT04067622 study?
This clinical trial studies the following conditions: Critical Illness, Sepsis, ARDS, Acute Respiratory Failure, Encephalopathy.
What interventions are being tested in trial NCT04067622?
The interventions under investigation include: Exersides (DEVICE).
Who is sponsoring clinical trial NCT04067622?
This trial is sponsored by University of Vermont, which has 162 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04067622 being conducted?
This trial has 3 study locations across California, Maryland, Vermont. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04067622's enrollment target sits among peer trials
58 76th of 91 higher than 16 of 91 other Critical Illness trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Critical Illness trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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