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

Safety Issues Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05180552
• Other study ID #: TBA2022
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 10, 2028
• Est. completion date: September 10, 2030

Study information

• Verified date: November 2023
• Source: Milton S. Hershey Medical Center
• Contact: Eliessa Caplan, DNP
• Phone: 9048145458
• Email: ecaplan[@]pennstatehealth.psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 10, 2030
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Device Ineffective
• Safety Issues

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

References & Publications (13)

Ai ZP, Gao XL, Zhao XL. Factors associated with unplanned extubation in the Intensive Care Unit for adult patients: A systematic review and meta-analysis. Intensive Crit Care Nurs. 2018 Aug;47:62-68. doi: 10.1016/j.iccn.2018.03.008. Epub 2018 Apr 10. — View Citation

Arumugam S, El-Menyar A, Al-Hassani A, Strandvik G, Asim M, Mekkodithal A, Mudali I, Al-Thani H. Delirium in the Intensive Care Unit. J Emerg Trauma Shock. 2017 Jan-Mar;10(1):37-46. doi: 10.4103/0974-2700.199520. — View Citation

Balci H, Arslan S. Nurses' Information, Attitude and Practices towards Use of Physical Restraint in Intensive Care Units. J Caring Sci. 2018 Jun 1;7(2):75-81. doi: 10.15171/jcs.2018.012. eCollection 2018 Jun. — View Citation

Burry L, Rose L, Ricou B. Physical restraint: time to let go. Intensive Care Med. 2018 Aug;44(8):1296-1298. doi: 10.1007/s00134-017-5000-0. Epub 2017 Nov 23. No abstract available. — View Citation

Jiang H, Li C, Gu Y, He Y. Nurses' perceptions and practice of physical restraint in China. Nurs Ethics. 2015 Sep;22(6):652-60. doi: 10.1177/0969733014557118. Epub 2014 Dec 8. — View Citation

Johnson K, Curry V, Steubing A, Diana S, McCray A, McFarren A, Domb A. A non-pharmacologic approach to decrease restraint use. Intensive Crit Care Nurs. 2016 Jun;34:12-9. doi: 10.1016/j.iccn.2015.08.004. Epub 2015 Dec 1. — View Citation

Kwon E, Choi K. Case-control Study on Risk Factors of Unplanned Extubation Based on Patient Safety Model in Critically Ill Patients with Mechanical Ventilation. Asian Nurs Res (Korean Soc Nurs Sci). 2017 Mar;11(1):74-78. doi: 10.1016/j.anr.2017.03.004. Epub 2017 Mar 25. — View Citation

Lach HW, Leach KM, Butcher HK. Evidence-Based Practice Guideline: Changing the Practice of Physical Restraint Use in Acute Care. J Gerontol Nurs. 2016 Feb;42(2):17-26. doi: 10.3928/00989134-20160113-04. — View Citation

LeBlanc A, Bourbonnais FF, Harrison D, Tousignant K. The experience of intensive care nurses caring for patients with delirium: A phenomenological study. Intensive Crit Care Nurs. 2018 Feb;44:92-98. doi: 10.1016/j.iccn.2017.09.002. Epub 2017 Oct 6. — View Citation

Perez D, Peters K, Wilkes L, Murphy G. PHYSICAL RESTRAINTS IN INTENSIVE CARE: EXPERIENCES OF PATIENTS, FAMILIES AND NURSES. Aust Nurs Midwifery J. 2017 May;24(10):45. — View Citation

Rose L, Dale C, Smith OM, Burry L, Enright G, Fergusson D, Sinha S, Wiesenfeld L, Sinuff T, Mehta S. A mixed-methods systematic review protocol to examine the use of physical restraint with critically ill adults and strategies for minimizing their use. Syst Rev. 2016 Nov 21;5(1):194. doi: 10.1186/s13643-016-0372-8. — View Citation

Souza LMDS, Santana RF, Capeletto CDSG, Menezes AK, Delvalle R. Factors associated with mechanical restraint in the hospital environment: a cross-sectional study. Rev Esc Enferm USP. 2019 Jun 13;53:e03473. doi: 10.1590/S1980-220X2018007303473. English, Portuguese. — View Citation

Staggs VS, Olds DM, Cramer E, Shorr RI. Nursing Skill Mix, Nurse Staffing Level, and Physical Restraint Use in US Hospitals: a Longitudinal Study. J Gen Intern Med. 2017 Jan;32(1):35-41. doi: 10.1007/s11606-016-3830-z. Epub 2016 Aug 23. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unplanned removal of devices	Frequency of unplanned removal of lines and self-extubation	End of intubation (average 7 days)
Secondary	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)
Secondary	Days on the ventilator that each patient group remains	Days on the ventilator	End of intubation (average 7 days)
Secondary	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)
Secondary	Fentanyl Dosing	Total Fentanyl dosing in mcg/kg	1 Day
Secondary	Propofol Dosing	Total Propofol dosing in mg/kg	1 Day
Secondary	Midazolam Dosing	Total Midazolam dosing in mg/kg	1 Day