The HEALiX™ Intubated Patient (IP) Pilot Study

Lancaster General Hospital

Status: Withdrawn

Conditions: Device Ineffective; Safety Issues

Treatments: Device: HEALiX

Study type: Interventional

Funder types: Other

Identifiers

NCT04759066

HEALiX IP Pilot

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Experimental

Experimental group

Description:

Participants will wear HEALiX device

Treatment:

Device: HEALiX