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Primary investigator moved to a new institution.
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Participants will wear HEALiX device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HEALiX | Device | HEALiX is a non-restraint patient safety device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Unplanned removal of devices | Frequency of unplanned removal of lines and self-extubation | up to 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Availability of device |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Caplan, DNP-C | Penn Medicine Lancaster General Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lancaster General Health | Lancaster | Pennsylvania | 17602 | United States |
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Single group descriptive pilot study
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Number of times during the study period that the correct size of HEALiX is not available.
| 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. | up to 2 weeks |
| Ease of application | Proportion of incorrectly to correctly sized HEALiX applications | 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 | up to 1 week |
| Education around device | Length of time it takes to train the staff in the three participating Intensive Care Units | up to 12 weeks |