The HEALiX™ Intubated Patient (IP) Pilot Study

Not Applicable

Withdrawn

• Conditions: Device Ineffective; Safety Issues
• Interventions: Device: HEALiX

• Registration Number: NCT04759066
• Lead Sponsor: Lancaster General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-12
• Study First Submitted QC: 2021-02-16
• Study First Posted: 2021-02-18
• Study Start: 2021-10-01
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-13
• Last Update Posted: 2022-01-03
• Primary Completion: 2022-03-31
• Study Completion: 2022-06-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	HEALiX	Participants will wear HEALiX device

Primary Outcome Measures

Name	Time	Method
Unplanned removal of devices	up to 2 weeks	Frequency of unplanned removal of lines and self-extubation

Secondary Outcome Measures

Name	Time	Method
Ease of device use	up to 2 weeks	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.
Alternate device use	up to 2 weeks	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.
Acceptability of device	up to 1 week	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
Availability of device	up to 2 weeks	Number of times during the study period that the correct size of HEALiX is not available.
Education around device	up to 12 weeks	Length of time it takes to train the staff in the three participating Intensive Care Units
Ease of application	up to 1 week	Proportion of incorrectly to correctly sized HEALiX applications

Trial Locations

Locations (1)

Lancaster General Health; 🇺🇸 Lancaster, Pennsylvania, United States