Status:
WITHDRAWN
The HEALiX™ Intubated Patient (IP) Pilot Study
Lead Sponsor:
Lancaster General Hospital
Conditions:
Device Ineffective
Safety Issues
Eligibility:
All Genders
18-89 years
Phase:
NA
Brief Summary
The current standard of care for limiting the movement of mechanically ventilated critical care patients is the use of physical wrist restraints, which are both ineffective in preventing removal of in...
Eligibility Criteria
Inclusion
- speak English
- legally authorized representative must speak English
- admitted by one of the services presiding over the selected intensive care units
- mechanically ventilated receiving analgesic-sedating medications
- have soft wrist restraints applied as part of their care plan documented in the medical record to reduce the risk of unplanned removal of medical devices
Exclusion
- pregnant women
- prisoners
- patients who are in a medically induced coma or in a comatose state (Glasgow Coma Scale \<8) for any reason
Key Trial Info
Start Date :
October 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04759066
Start Date
October 1 2021
End Date
June 1 2022
Last Update
January 3 2022
Active Locations (1)
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1
Lancaster General Health
Lancaster, Pennsylvania, United States, 17602