Device Ineffective, Safety Issues
Conditions
Keywords
self-extubation, non-restraint device, removal of lines
Brief 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.
Interventions
DEVICEHEALiX
HEALiX is a non-restraint patient safety device
Sponsors
Lancaster General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Single group descriptive pilot study
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unplanned removal of devices | up to 2 weeks | Frequency of unplanned removal of lines and self-extubation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Availability of device | up to 2 weeks | Number of times during the study period that the correct size of HEALiX is not available. |
| Alternate device use | up to 2 weeks | 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. |
| Ease of device use | up to 2 weeks | 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. |
| Acceptability of device | up to 1 week | 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 |
| Education around device | up to 12 weeks | Length of time it takes to train the staff in the three participating Intensive Care Units |
| Ease of application | up to 1 week | Proportion of incorrectly to correctly sized HEALiX applications |
Countries
United States
Outcome results
None listed