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

Penn State Health

Status: Withdrawn

Conditions: Device Ineffective; Device Intolerance; Safety Issues; Device Dislodgement

Treatments: Device: HEALiX is an alternative restraint patient safety device; Device: soft wrist restraints

Study type: Interventional

Funder types: Other

Identifiers

NCT05180552

TBA2022

Details and patient eligibility

About

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.

Full description

This randomized controlled trial's primary purpose is to determine the efficacy of the HEALiX compared with wrist restraints in the adult, intubated patient in the critical care and intermediate care setting. The study's secondary purpose is to understand the acceptability of the HEALiX from healthcare professionals' perspective providing care at the bedside. By recruiting participants for use in the HEALiX RCT study and using the HEALiX with patients during care, the PI will gather information regarding the comparative effectiveness of the HEALiX in a population of critical care patients. This RCT trial will use a quantitative, comparative approach using an experimental and control study group design to measure and compare the outcomes after the subjects are placed in either the HEALiX or wrist restraints.

The setting for the HEALiX Pilot Study will be Penn State Hershey Medical Center in Hershey Pennsylvania. The specific location for the trial will be in several of the academic medical center's critical care units, including Heart and Vascular ICU (HVICU), Surgical Anesthesia ICU (SICU), Neurosurgical Intensive Care Unit (NSICU), and Medical Intensive Care Unit (MICU). Key nursing unit leaders and leaders from other service lines whose clinical input was essential to contribute to this RCT trial's success gave permission to conduct this study.

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Mechanically ventilated (with or without tracheostomy)
2. Receiving analgesic-sedating medications
3. Wearing soft wrist restraints
4. Glasgow Coma Scale score > 8
5. Participants must be between ages 18-89 years old
6. English-speaking
7. English speaking legalized authorized representative (LAR)
8. Participants must be admitted under one of the following physician groups: Trauma services or critical care physician group.

Exclusion criteria

1. Children (under age 18)
2. Pregnant women
3. Cognitively impaired adults (must be able to follow commands)
4. Prisoners
5. Combative patients

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Experimental

Experimental group

Description:

Participants will wear HEALiX Device while intubated and sedated in the critical care setting

Treatment:

Device: HEALiX is an alternative restraint patient safety device

Control

Active Comparator group

Description:

Participants will wear wrist restraints while intubated and sedated in the critical care setting

Treatment:

Device: soft wrist restraints