Device IneffectiveNCT04759066
The HEALiX™ Intubated Patient (IP) Pilot Study
A study testing HEALiX in people with Device Ineffective and Safety Issues, run by Lancaster General Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Device Ineffective, Safety Issues
- What is being tested?
- HEALiX
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- pregnant women
- prisoners
- patients who are in a medically induced coma or in a comatose state (Glasgow Coma Scale <8) for any reason
Trial locations and contacts
1 site in 1 country.
United States1 site
Lancaster General Health
Lancaster, Pennsylvania, 17602
About this study
Official title: Assessment of an Alternative to Physical Wrist Restraints in Adult Intubated Patients in the Intensive Care Unit: The HEALiX™ Intubated Patient (IP) Pilot Study
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
- Being tested
- HEALiX
- Keywords
- self-extubation, non-restraint device, removal of lines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEALiXDevice
HEALiX is a non-restraint patient safety device
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Participants will wear HEALiX device Receives: Device: HEALiX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unplanned removal of devices
Frequency of unplanned removal of lines and self-extubation
Measured: up to 2 weeks
Secondary outcomes (6)
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.
Measured: up to 2 weeks
Availability of device
Number of times during the study period that the correct size of HEALiX is not available.
Measured: 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.
Measured: up to 2 weeks
Ease of application
Proportion of incorrectly to correctly sized HEALiX applications
Measured: 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
Measured: up to 1 week
Education around device
Length of time it takes to train the staff in the three participating Intensive Care Units
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start1 Oct 2021 (estimated)
- Primary completion31 Mar 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Why it stopped: Primary investigator moved to a new institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Device IneffectiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group descriptive pilot study
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lancaster General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa Caplan, DNP-C, Principal investigator, Penn Medicine Lancaster General Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04759066
- Sponsor's protocol ID
- HEALiX IP Pilot
- Status last verified
- Dec 2021
- First submitted
- 12 Feb 2021
- Last updated
- 3 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of an Alternative to Physical Wrist Restraints in Adult Intubated Patients in the Intensive Care Unit: The HEALiX™ Intubated Patient (IP) Pilot Study
- ClinicalTrials.gov ID
- NCT04759066
- Acronym / sponsor ID
- HEALiX IP Pilot
- Conditions
- Device Ineffective, Safety Issues
- Keywords
- self-extubation, non-restraint device, removal of lines
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Primary investigator moved to a new institution.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Lancaster General HospitalUniversity, hospital or other
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 18 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group descriptive pilot study
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: HEALiXParticipants will wear HEALiX device |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- pregnant women
- prisoners
- patients who are in a medically induced coma or in a comatose state (Glasgow Coma Scale <8) for any reason
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HEALiXHEALiX is a non-restraint patient safety device | Device | Experimental |
Primary outcome
Unplanned removal of devices
Time frame: up to 2 weeks
Frequency of unplanned removal of lines and self-extubation
6 secondary outcomes
Ease of device use
Time frame: up to 2 weeks
Availability of device
Time frame: up to 2 weeks
Alternate device use
Time frame: up to 2 weeks
Ease of application
Time frame: up to 1 week
Acceptability of device
Time frame: up to 1 week
Education around device
Time frame: up to 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Caplan, DNP-C principal investigator
Penn Medicine Lancaster General Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HEALiX in people with Device Ineffective and Safety Issues, run by Lancaster General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unplanned removal of devices (time frame: up to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2022.