The HEALiX™ Intubated Patient (IP) Pilot Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2022-06-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Device Ineffective Safety Issues

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single group descriptive pilot study

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Experimental

Participants will wear HEALiX device

Group Type EXPERIMENTAL

HEALiX

Intervention Type DEVICE

HEALiX is a non-restraint patient safety device

Interventions

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HEALiX

HEALiX is a non-restraint patient safety device

Intervention Type DEVICE

Eligibility Criteria

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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