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

Summary

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.

Conditions

• Safety Issues
• Device Dislodgement
• Device Intolerance
• Device Ineffective

Interventions

DEVICE

HEALiX is an alternative restraint patient safety device

The HEALiX is a rigid, spiral, exoskeleton-like device made of lightweight stainless steel (Austenitic SAE 316 or equivalent) that comes in various sizes to fit different arm lengths circumference of the patient's bicep. After appropriate measuring and following the fit guide, the HEALiX is placed on the patient's arm so that the hand rests on a soft, padded hand cradle. The trajectory of the end hand cradle is at a 30-degree upward angle to prevent peripheral dependent edema. This hand cradle is surrounded by foam to provide increased support for the patient and also to protect the medical team from any injury. A wrist bracelet (wrist assist) goes around the patient's wrist and prevents the patient from removing the device. The spiral exoskeleton holds the arm in a neutral position with contact points with the patient's skin at the upper deltoid region only.

DEVICE

soft wrist restraints

Soft wrist restraints are padded cloth restraints that are worn by patients on wrist and secured to bed frame.

Sponsors & Collaborators

• Milton S. Hershey Medical Center

  lead OTHER

Principal Investigators

• Eliessa Caplan, DNP · Milton S. Hershey Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2028-08-10

Primary Completion

2028-12-31

Completion

2030-09-10