The HEALiX™ Intubated Patient (IP) Pilot Study

Lancaster General Hospital

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Conditions

Device Ineffective Safety Issues

Interventions

HEALiXDEVICE

HEALiX is a non-restraint patient safety device

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 Years

Medical Language ↔ Plain English

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

Locations (1)

Lancaster General Health

Lancaster, Pennsylvania, United States

Outcomes

Primary Outcomes

Unplanned removal of devices

Frequency of unplanned removal of lines and self-extubation

Time frame: up to 2 weeks

Secondary Outcomes

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.

Time frame: up to 2 weeks

Availability of device

Number of times during the study period that the correct size of HEALiX is not available.

Time frame: up to 2 weeks

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.

Time frame: up to 2 weeks

Ease of application

Proportion of incorrectly to correctly sized HEALiX applications

Time frame: up to 1 week

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

Time frame: up to 1 week

Education around device

Length of time it takes to train the staff in the three participating Intensive Care Units

Time frame: up to 12 weeks

Data from ClinicalTrials.gov

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