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

November 4, 2023 updated by: Eliessa Caplan, Milton S. Hershey Medical Center

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
Participants will wear HEALiX Device while intubated and sedated in the critical care setting
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.
Active Comparator: Control
Participants will wear wrist restraints while intubated and sedated in the critical care setting
Device: soft wrist restraints
Soft wrist restraints are padded cloth restraints that are worn by patients on wrist and secured to bed frame.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unplanned removal of devices
Time Frame: End of intubation (average 7 days)
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
Time Frame: End of intubation (average 7 days)
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
Time Frame: End of intubation (average 7 days)
Days on the ventilator
End of intubation (average 7 days)
Number of days in the ICU that each patient group remains
Time Frame: End of ICU stay when patient is transferred to lower level of care (average 10 days)
Days in ICU
End of ICU stay when patient is transferred to lower level of care (average 10 days)
Fentanyl Dosing
Time Frame: 1 Day
Total Fentanyl dosing in mcg/kg
1 Day
Propofol Dosing
Time Frame: 1 Day
Total Propofol dosing in mg/kg
1 Day
Midazolam Dosing
Time Frame: 1 Day
Total Midazolam dosing in mg/kg
1 Day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Investigators

  • Principal Investigator: Eliessa Caplan, DNP, Milton S. Hershey Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 10, 2028

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

September 10, 2030

Study Registration Dates

First Submitted

December 17, 2021

First Submitted That Met QC Criteria

January 5, 2022

First Posted (Actual)

January 6, 2022

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 4, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TBA2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Plan to publish in multiple nursing journals and attend research conferences.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Safety Issues

Clinical Trials on HEALiX is an alternative restraint patient safety device

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Madagascar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe