Clinical trial NCT05180552: The HEALiX: Comparing the Efficacy of the HEALiX Device With Wrist Restraints in a Critical Care Setting
Official title: The HEALiX Trial: Comparing the Efficacy of the HEALiX Device With Wrist Restraints in a Critical Care Setting
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Safety Issues
Device Dislodgement
Device Intolerance
Device Ineffective
Keywords: unplanned extubation
restraints
device removal
critical care unit
patient safety
wrist restraints
sedation
standard of care
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2022-01-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Unplanned removal of devices
timeFrame: End of intubation (average 7 days)
Secondary outcomes:
measure: Ease of device use
timeFrame: End of intubation (average 7 days)
measure: Days on the ventilator that each patient group remains
timeFrame: End of intubation (average 7 days)
measure: Number of days in the ICU that each patient group remains
timeFrame: End of ICU stay when patient is transferred to lower level of care (average 10 days)
measure: Fentanyl Dosing
timeFrame: 1 Day
measure: Propofol Dosing
timeFrame: 1 Day
measure: Midazolam Dosing
timeFrame: 1 Day
Other outcomes:
Locations:
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Eliessa Caplan, DNP
role: PRINCIPAL_INVESTIGATOR
References:
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