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

NCT05180552 | Withdrawn

• 1 other identifier: TBA2022
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• Unplanned removal of devices

  Frequency of unplanned removal of lines and self-extubation

  End of intubation (average 7 days)

Secondary Outcomes (6)

• Ease of device use

  End of intubation (average 7 days)

• Days on the ventilator that each patient group remains

  End of intubation (average 7 days)

• Number of days in the ICU that each patient group remains

  End of ICU stay when patient is transferred to lower level of care (average 10 days)

• Fentanyl Dosing

  1 Day

• Propofol Dosing

  1 Day

Study Arms (2)

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

Control

ACTIVE COMPARATOR

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

Device: soft wrist restraints

Interventions

HEALiX is an alternative restraint patient safety device 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.

Experimental

soft wrist restraints DEVICE

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

Control

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Children (under age 18)
• Pregnant women
• Cognitively impaired adults (must be able to follow commands)
• Prisoners
• Combative patients

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Related Publications (13)

• 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.

  PMID: 28243012 BACKGROUND

• 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.

  PMID: 29977877 BACKGROUND

• 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.

  PMID: 29170870 BACKGROUND

• 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.

  PMID: 25488757 BACKGROUND

• 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.

  PMID: 26652790 BACKGROUND

• 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.

  PMID: 28388984 BACKGROUND

• 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.

  PMID: 26820185 BACKGROUND

• 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.

  PMID: 28993046 BACKGROUND

• 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.

  PMID: 29280605 BACKGROUND

• 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.

  PMID: 27871314 BACKGROUND

• 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.

  PMID: 31215614 BACKGROUND

• 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.

  PMID: 27553206 BACKGROUND

• 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.

  PMID: 29653888 BACKGROUND

Study Officials

• Eliessa Caplan, DNP

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Eliessa Caplan, BS, MSN, DNP, RN, CCRN Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 17, 2021
• First Posted: January 6, 2022
• Study Start (Estimated): August 10, 2028
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): September 10, 2030
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share