The HEALiX™ Intubated Patient (IP) Pilot Study

NCT04759066 | Withdrawn

• 1 other identifier: HEALiX IP Pilot
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Device Ineffective; Safety Issues

Keywords

self-extubation; non-restraint device; removal of lines

Outcome Measures

Primary Outcomes (1)

• Unplanned removal of devices

  Frequency of unplanned removal of lines and self-extubation

  up to 2 weeks

Secondary Outcomes (6)

• Ease of device use

  up to 2 weeks

• Availability of device

  up to 2 weeks

• Alternate device use

  up to 2 weeks

• Ease of application

  up to 1 week

• Acceptability of device

  up to 1 week

Study Arms (1)

Experimental

EXPERIMENTAL

Participants will wear HEALiX device

Device: HEALiX

Interventions

HEALiX DEVICE

HEALiX is a non-restraint patient safety device

Experimental

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Lancaster General Hospital: lead

Study Sites (1)

Lancaster General Health

Lancaster, Pennsylvania, 17602, United States

Location

Study Officials

• Lisa Caplan, DNP-C

  Penn Medicine Lancaster General Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single group descriptive pilot study

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: February 18, 2021
• Study Start: October 1, 2021
• Primary Completion: March 31, 2022
• Study Completion: June 1, 2022
• Last Updated: January 3, 2022

Record last verified: 2021-12

Locations

US (1)