The HEALiX™ Intubated Patient (IP) Pilot Study

Assessment of an Alternative to Physical Wrist Restraints in Adult Intubated Patients in the Intensive Care Unit: The HEALiX™ Intubated Patient (IP) Pilot Study

The current standard of care for limiting the movement of mechanically ventilated critical care patients is the use of physical wrist restraints, which are both ineffective in preventing removal of invasive and adjunct respiratory support devices and have a multitude of negative physical and psychological consequences for the patient. The objective of the proposed research is to test an innovative device designed to allow more freedom of movement of mechanically ventilated patients without bending of the arms, thereby preventing removal of adjunct mechanical ventilation devices and invasive monitoring equipment.

Study Overview

• Status: Withdrawn
• Conditions: Safety Issues; Device Ineffective
• Intervention / Treatment: Device: HEALiX

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17602
      • Lancaster General Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• speak English
• legally authorized representative must speak English
• admitted by one of the services presiding over the selected intensive care units
• mechanically ventilated receiving analgesic-sedating medications
• have soft wrist restraints applied as part of their care plan documented in the medical record to reduce the risk of unplanned removal of medical devices

Exclusion Criteria:

• pregnant women
• prisoners
• patients who are in a medically induced coma or in a comatose state (Glasgow Coma Scale <8) for any reason

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Participants will wear HEALiX device	Device: HEALiX; HEALiX is a non-restraint patient safety device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unplanned removal of devices	Frequency of unplanned removal of lines and self-extubation	up to 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ease of device use	Staff perception of ease of locating the correct size of the device, applying it, caring for the patient using HEALiX, cleaning it after use, and returning it for storage.	up to 2 weeks
Availability of device	Number of times during the study period that the correct size of HEALiX is not available.	up to 2 weeks
Alternate device use	Number of patients who have HEALiX device removed by staff and replaced by soft wrist restraints or other limb limiting application, and the reason for removal.	up to 2 weeks
Ease of application	Proportion of incorrectly to correctly sized HEALiX applications	up to 1 week
Acceptability of device	Average length of time for a member of the research team to discuss the HEALiX Pilot Study with a patient's family member in person and phone until decision is made about participation	up to 1 week
Education around device	Length of time it takes to train the staff in the three participating Intensive Care Units	up to 12 weeks

Collaborators and Investigators

• Sponsor: Lancaster General Hospital
• Investigators: Principal Investigator: Lisa Caplan, DNP-C, Penn Medicine Lancaster General Health

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2021
• Primary Completion (Anticipated): March 31, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: February 12, 2021
• First Submitted That Met QC Criteria: February 16, 2021
• First Posted (Actual): February 18, 2021

Study Record Updates

• Last Update Posted (Actual): January 3, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: self-extubation; non-restraint device; removal of lines
• Other Study ID Numbers: HEALiX IP Pilot

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No