The HEALiX™ Intubated Patient (IP) Pilot Study

Safety Issues Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04759066
• Other study ID #: HEALiX IP Pilot
• Status: Withdrawn
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: December 2021
• Source: Lancaster General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 1, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Device Ineffective
• Safety Issues

Intervention

Device:
• HEALiX
HEALiX is a non-restraint patient safety device

Locations

Country	Name	City	State
United States	Lancaster General Health	Lancaster	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Lancaster General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unplanned removal of devices	Frequency of unplanned removal of lines and self-extubation	up to 2 weeks
Secondary	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
Secondary	Availability of device	Number of times during the study period that the correct size of HEALiX is not available.	up to 2 weeks
Secondary	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
Secondary	Ease of application	Proportion of incorrectly to correctly sized HEALiX applications	up to 1 week
Secondary	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
Secondary	Education around device	Length of time it takes to train the staff in the three participating Intensive Care Units	up to 12 weeks