The HEALiX™ Intubated Patient (IP) Pilot Study

Withdrawn before enrolling · Not applicable

Conditions studied: Device Ineffective, Safety Issues

In brief

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 invasive and adjunct respiratory support devices and have a multitude of negative physical and psychological consequences for the patient. The objective of the proposed research is to test an innovative device designed to allow more freedom of movement of mechanically ventilated patients without bending of the arms, thereby preventing removal of adjunct mechanical ventilation devices and invasive monitoring equipment.

Key facts

Study ID

NCT04759066

Run by

Lancaster General Hospital

People needed

0

Starts

2021-10-01

Expected to finish

2022-06-01

Last updated by the study team

2022-01-03

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• pregnant women
• prisoners
• patients who are in a medically induced coma or in a comatose state (Glasgow Coma Scale <8) for any reason

Where it is running

• Lancaster General Health — Lancaster, Pennsylvania, United States

Full record on ClinicalTrials.gov

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