NCT05180552

The HEALiX: Comparing the Efficacy of the HEALiX Device With Wrist Restraints in a Critical Care Setting

Withdrawn NA Last updated 18 December 2024

What this trial tests

NA trial testing HEALiX is an alternative restraint patient safety device in Safety Issues. Withdrawn.

Timeline

10 August 2028

Primary endpoint
31 December 2028

10 September 2030

Quick facts

Lead sponsor	Milton S. Hershey Medical Center
Phase	NA
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Start date	10 August 2028
Primary completion	31 December 2028
Estimated completion	10 September 2030

Drugs / interventions tested

• HEALiX is an alternative restraint patient safety device
• soft wrist restraints

Conditions studied

• Safety Issues — all drugs for Safety Issues →
• Device Dislodgement — all drugs for Device Dislodgement →
• Device Intolerance — all drugs for Device Intolerance →
• Device Ineffective — all drugs for Device Ineffective →

Sponsor

Milton S. Hershey Medical Center

Who can join

Adults 18 to 99, any sex, with Safety Issues or Device Dislodgement. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The treatment plan for patients requiring mechanical ventilator support is to provide the minimal amount of analgesics and sedatives necessary for the patient to tolerate the ventilator as lower amounts of these drugs has been shown to improve patient outcomes. Patients in this critical state experience confusion, restlessness, and agitation, which sometimes leads to an unplanned removal of a patient's line or medical device. The current standard of care for limiting the movement of mechanically ventilated patients' in the critical care units in hospitals is the use of physical wrist restraints. Researchers demonstrated that wrist restraints are ineffective in preventing the removal of invasive and adjunct devices and have many negative physical, psychological, physiological, and emotional consequences for the patient and their family. In this proposed research, we will use the innovative medical device called the HEALiX, a newly developed device worn on the arms of mechanically ventilated patients that allows freedom of movement and protects from removing adjunct mechanical ventilation devices and invasive monitoring equipment. This randomized controlled trial will investigate the HEALiX device's effectiveness in preventing the removal of invasive monitoring devices (such as endotracheal tubes, central lines, feeding tubes, etc.) compared with the current standard of care, wrist restraints.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.