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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Device Ineffective, Safety Issues, Device Dislodgement, Device Intolerance

Intervention / Treatment
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* Device: HEALiX is an alternative restraint patient safety device
* Device: soft wrist restraints


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mechanically ventilated (with or without tracheostomy) Receiving analgesic-sedating medications Wearing soft wrist restraints Glasgow Coma Scale score > 8 Participants must be between ages 18-89 years old English-speaking English speaking legalized authorized representative (LAR) Participants must be admitted under one of the following physician groups: Trauma services or critical care physician group. Exclusion Criteria: Children (under age 18) Pregnant women Cognitively impaired adults (must be able to follow commands) Prisoners Combative patients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This randomized control 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Participants will wear HEALiX Device while intubated and sedated in the critical care setting | Device: HEALiX is an alternative restraint patient safety device<br>* 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.<br>|
| Active Comparator: Control<br>Participants will wear wrist restraints while intubated and sedated in the critical care setting | Device: soft wrist restraints<br>* Soft wrist restraints are padded cloth restraints that are worn by patients on wrist and secured to bed frame.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unplanned removal of devices | Frequency of unplanned removal of lines and self-extubation | End of intubation (average 7 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of device use | Staff perception of ease of HEALiX sizing, application and removal based on Likert scale where 0 is prohibitively hard to use and 5 is extraordinarily easy to use | End of intubation (average 7 days) | 
| Days on the ventilator that each patient group remains | Days on the ventilator | End of intubation (average 7 days) | 
| Number of days in the ICU that each patient group remains | Days in ICU | End of ICU stay when patient is transferred to lower level of care (average 10 days) | 
| Fentanyl Dosing | Total Fentanyl dosing in mcg/kg | 1 Day | 
| Propofol Dosing | Total Propofol dosing in mg/kg | 1 Day | 
| Midazolam Dosing | Total Midazolam dosing in mg/kg | 1 Day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unplanned extubation, restraints, device removal, critical care unit, patient safety, wrist restraints, sedation, standard of care