NCT04759066

The HEALiX™ Intubated Patient (IP) Pilot Study

Assessment of an Alternative to Physical Wrist Restraints in Adult Intubated Patients in the Intensive Care Unit: The HEALiX™ Intubated Patient (IP) Pilot Study

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Lancaster General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Device Ineffective
• Safety Issues

Interventions

Type	Name	Description
DEVICE	HEALiX	HEALiX is a non-restraint patient safety device

Timeline

• Start date: 2021-10-01
• Primary completion: 2022-03-31
• Completion: 2022-06-01
• First posted: 2021-02-18
• Last updated: 2022-01-03

Locations

1 site across 1 country: United States