At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 8 enrolled
Drug / intervention
Novel restraintdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pilot Study of a Novel Arm Restraint For Critically Ill Patients
In Brief
A Phase 1 clinical trial evaluating Novel restraint for Acute Respiratory Failure. Completed, enrolled 8 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Respiratory Failure
CountriesUnited States
CollaboratorsHealthy Design, LLC
Timeline
Phase 1CompletedFinished
20192020202120222023202420252026
First PostedAug 2018
Enrollment StartOct 2018
Primary CompletionApr 2019
Study CompletionApr 2019
TodayJul 2026
First PostedAug 8, 2018
Enrollment StartOct 1, 2018
Primary CompletionApr 11, 2019
Study CompletionApr 15, 2019
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 7.9 years ago
Interventions
Novel restraintdevice
Use of a novel arm restraint