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The HEALiX™ Intubated Patient (IP) Pilot Study

NCT04759066 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-01-03

No results posted yet for this study

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

Interventions

DEVICE

HEALiX

HEALiX is a non-restraint patient safety device

Sponsors & Collaborators

  • Lancaster General Hospital

    lead OTHER

Principal Investigators

  • Lisa Caplan, DNP-C · Penn Medicine Lancaster General Health

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2022-03-31
Completion
2022-06-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04759066 on ClinicalTrials.gov