Safety IssuesNCT05180552
The HEALiX: Comparing the Efficacy of the HEALiX Device With Wrist Restraints in a Critical Care Setting
A study testing HEALiX is an alternative restraint patient safety device and soft wrist restraints in people with Safety Issues and Device Dislodgement, run by Milton S. Hershey Medical Center.
Trial summary
The treatment plan for patients requiring mechanical ventilator support is to provide the minimal amount of analgesics and sedatives necessary for the patient to tolerate the ventilator as lower amounts of these drugs has been shown to improve patient outcomes. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Safety Issues, Device Dislodgement, Device Intolerance
- What is being tested?
- HEALiX is an alternative restraint patient safety device and soft wrist restraints
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 10 Aug 2028to 10 Sep 2030
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mechanically ventilated (with or without tracheostomy)
- Receiving analgesic-sedating medications
- Wearing soft wrist restraints
- Glasgow Coma Scale score > 8
- Participants must be between ages 18-89 years old
- English-speaking
- English speaking legalized authorized representative (LAR)
- Participants must be admitted under one of the following physician groups: Trauma services or critical care physician group.
Who cannot join
- Children (under age 18)
- Pregnant women
- Cognitively impaired adults (must be able to follow commands)
- Prisoners
- Combative patients
About this study
Official title: The HEALiX Trial: Comparing the Efficacy of the HEALiX Device With Wrist Restraints in a Critical Care Setting
The treatment plan for patients requiring mechanical ventilator support is to provide the minimal amount of analgesics and sedatives necessary for the patient to tolerate the ventilator as lower amounts of these drugs has been shown to improve patient outcomes. Patients in this critical state experience confusion, restlessness, and agitation, which sometimes leads to an unplanned removal of a patient's line or medical device. The current standard of care for limiting the movement of mechanically ventilated patients' in the critical care units in hospitals is the use of physical wrist restraints. Researchers demonstrated that wrist restraints are ineffective in preventing the removal of invasive and adjunct devices and have many negative physical, psychological, physiological, and emotional consequences for the patient and their family. In this proposed research, we will use the innovative medical device called the HEALiX, a newly developed device worn on the arms of mechanically ventilated patients that allows freedom of movement and protects from removing adjunct mechanical ventilation devices and invasive monitoring equipment. This randomized controlled trial will investigate the HEALiX device's effectiveness in preventing the removal of invasive monitoring devices (such as endotracheal tubes, central lines, feeding tubes, etc.) compared with the current standard of care, wrist restraints.
Read the detailed description
This randomized controlled trial's primary purpose is to determine the efficacy of the HEALiX compared with wrist restraints in the adult, intubated patient in the critical care and intermediate care setting. The study's secondary purpose is to understand the acceptability of the HEALiX from healthcare professionals' perspective providing care at the bedside. By recruiting participants for use in the HEALiX RCT study and using the HEALiX with patients during care, the PI will gather information regarding the comparative effectiveness of the HEALiX in a population of critical care patients. This RCT trial will use a quantitative, comparative approach using an experimental and control study group design to measure and compare the outcomes after the subjects are placed in either the HEALiX or wrist restraints.
The setting for the HEALiX Pilot Study will be Penn State Hershey Medical Center in Hershey Pennsylvania. The specific location for the trial will be in several of the academic medical center's critical care units, including Heart and Vascular ICU (HVICU), Surgical Anesthesia ICU (SICU), Neurosurgical Intensive Care Unit (NSICU), and Medical Intensive Care Unit (MICU). Key nursing unit leaders and leaders from other service lines whose clinical input was essential to contribute to this RCT trial's success gave permission to conduct this study.
- Being tested
- HEALiX is an alternative restraint patient safety device, soft wrist restraints
- Keywords
- unplanned extubation, restraints, device removal, critical care unit, patient safety, wrist restraints, sedation, standard of care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEALiX is an alternative restraint patient safety deviceDevice
The HEALiX is a rigid, spiral, exoskeleton-like device made of lightweight stainless steel (Austenitic SAE 316 or equivalent) that comes in various sizes to fit different arm lengths circumference of the patient's bicep. After appropriate measuring and following the fit guide, the HEALiX is placed on the patient's arm so that the hand rests on a soft, padded hand cradle. The trajectory of the end hand cradle is at a 30-degree upward angle to prevent peripheral dependent edema. This hand cradle is surrounded by foam to provide increased support for the patient and also to protect the medical team from any injury. A wrist bracelet (wrist assist) goes around the patient's wrist and prevents the patient from removing the device. The spiral exoskeleton holds the arm in a neutral position with contact points with the patient's skin at the upper deltoid region only.
soft wrist restraintsDevice
Soft wrist restraints are padded cloth restraints that are worn by patients on wrist and secured to bed frame.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Participants will wear HEALiX Device while intubated and sedated in the critical care setting Receives: Device: HEALiX is an alternative restraint patient safety device |
| Control | Active comparator | Participants will wear wrist restraints while intubated and sedated in the critical care setting Receives: Device: soft wrist restraints |
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: End of intubation (average 7 days)
Secondary outcomes (6)
Ease of device use
Staff perception of ease of HEALiX sizing, application and removal based on Likert scale where 0 is prohibitively hard to use and 5 is extraordinarily easy to use
Measured: End of intubation (average 7 days)
Days on the ventilator that each patient group remains
Days on the ventilator
Measured: End of intubation (average 7 days)
Number of days in the ICU that each patient group remains
Days in ICU
Measured: End of ICU stay when patient is transferred to lower level of care (average 10 days)
Fentanyl Dosing
Total Fentanyl dosing in mcg/kg
Measured: 1 Day
Propofol Dosing
Total Propofol dosing in mg/kg
Measured: 1 Day
Midazolam Dosing
Total Midazolam dosing in mg/kg
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start10 Aug 2028 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion10 Sep 2030 (estimated)
Why it stopped: Unable to secure funding or liability insurance
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Safety IssuesStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This randomized control trial will use a quantitative, comparative approach using an experimental and control study group design to measure and compare the outcomes after the subjects are placed in either the HEALiX or wrist restraints.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eliessa Caplan, Milton S. Hershey Medical Center
- Investigators
- Eliessa Caplan, DNP, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05180552
- Sponsor's protocol ID
- TBA2022
- Status last verified
- Dec 2024
- First submitted
- 17 Dec 2021
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Plan to publish in multiple nursing journals and attend research conferences.
Publications
Arumugam S, El-Menyar A, Al-Hassani A, Strandvik G, Asim M, Mekkodithal A, Mudali I, Al-Thani H. Delirium in the Intensive Care Unit. J Emerg Trauma Shock. 2017 Jan-Mar;10(1):37-46. doi: 10.4103/0974-2700.199520.
PubMed 28243012Balci H, Arslan S. Nurses' Information, Attitude and Practices towards Use of Physical Restraint in Intensive Care Units. J Caring Sci. 2018 Jun 1;7(2):75-81. doi: 10.15171/jcs.2018.012. eCollection 2018 Jun.
PubMed 29977877Burry L, Rose L, Ricou B. Physical restraint: time to let go. Intensive Care Med. 2018 Aug;44(8):1296-1298. doi: 10.1007/s00134-017-5000-0. Epub 2017 Nov 23. No abstract available.
PubMed 29170870Jiang H, Li C, Gu Y, He Y. Nurses' perceptions and practice of physical restraint in China. Nurs Ethics. 2015 Sep;22(6):652-60. doi: 10.1177/0969733014557118. Epub 2014 Dec 8.
PubMed 25488757Johnson K, Curry V, Steubing A, Diana S, McCray A, McFarren A, Domb A. A non-pharmacologic approach to decrease restraint use. Intensive Crit Care Nurs. 2016 Jun;34:12-9. doi: 10.1016/j.iccn.2015.08.004. Epub 2015 Dec 1.
PubMed 26652790Kwon E, Choi K. Case-control Study on Risk Factors of Unplanned Extubation Based on Patient Safety Model in Critically Ill Patients with Mechanical Ventilation. Asian Nurs Res (Korean Soc Nurs Sci). 2017 Mar;11(1):74-78. doi: 10.1016/j.anr.2017.03.004. Epub 2017 Mar 25.
PubMed 28388984Lach HW, Leach KM, Butcher HK. Evidence-Based Practice Guideline: Changing the Practice of Physical Restraint Use in Acute Care. J Gerontol Nurs. 2016 Feb;42(2):17-26. doi: 10.3928/00989134-20160113-04.
PubMed 26820185LeBlanc A, Bourbonnais FF, Harrison D, Tousignant K. The experience of intensive care nurses caring for patients with delirium: A phenomenological study. Intensive Crit Care Nurs. 2018 Feb;44:92-98. doi: 10.1016/j.iccn.2017.09.002. Epub 2017 Oct 6.
PubMed 28993046Perez D, Peters K, Wilkes L, Murphy G. PHYSICAL RESTRAINTS IN INTENSIVE CARE: EXPERIENCES OF PATIENTS, FAMILIES AND NURSES. Aust Nurs Midwifery J. 2017 May;24(10):45.
PubMed 29280605Rose L, Dale C, Smith OM, Burry L, Enright G, Fergusson D, Sinha S, Wiesenfeld L, Sinuff T, Mehta S. A mixed-methods systematic review protocol to examine the use of physical restraint with critically ill adults and strategies for minimizing their use. Syst Rev. 2016 Nov 21;5(1):194. doi: 10.1186/s13643-016-0372-8.
PubMed 27871314Souza LMDS, Santana RF, Capeletto CDSG, Menezes AK, Delvalle R. Factors associated with mechanical restraint in the hospital environment: a cross-sectional study. Rev Esc Enferm USP. 2019 Jun 13;53:e03473. doi: 10.1590/S1980-220X2018007303473. English, Portuguese.
PubMed 31215614Staggs VS, Olds DM, Cramer E, Shorr RI. Nursing Skill Mix, Nurse Staffing Level, and Physical Restraint Use in US Hospitals: a Longitudinal Study. J Gen Intern Med. 2017 Jan;32(1):35-41. doi: 10.1007/s11606-016-3830-z. Epub 2016 Aug 23.
PubMed 27553206Ai ZP, Gao XL, Zhao XL. Factors associated with unplanned extubation in the Intensive Care Unit for adult patients: A systematic review and meta-analysis. Intensive Crit Care Nurs. 2018 Aug;47:62-68. doi: 10.1016/j.iccn.2018.03.008. Epub 2018 Apr 10.
PubMed 29653888
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The HEALiX Trial: Comparing the Efficacy of the HEALiX Device With Wrist Restraints in a Critical Care Setting
- ClinicalTrials.gov ID
- NCT05180552
- Acronym / sponsor ID
- TBA2022
- Keywords
- unplanned extubation, restraints, device removal, critical care unit, patient safety, wrist restraints, sedation, standard of care
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to secure funding or liability insurance
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 10 Aug 2028 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 10 Sep 2030 (estimated)
- First posted
- 6 Jan 2022 (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 treatment plan for patients requiring mechanical ventilator support is to provide the minimal amount of analgesics and sedatives necessary for the patient to tolerate the ventilator as lower amounts of these drugs has been shown to improve patient outcomes. Patients in this critical state experience confusion, restlessness, and agitation, which sometimes leads to an unplanned removal of a patient's line or medical device. The current standard of care for limiting the movement of mechanically ventilated patients' in the critical care units in hospitals is the use of physical wrist restraints. Researchers demonstrated that wrist restraints are ineffective in preventing the removal of invasive and adjunct devices and have many negative physical, psychological, physiological, and emotional consequences for the patient and their family. In this proposed research, we will use the innovative medical device called the HEALiX, a newly developed device worn on the arms of mechanically ventilated patients that allows freedom of movement and protects from removing adjunct mechanical ventilation devices and invasive monitoring equipment. This randomized controlled trial will investigate the HEALiX device's effectiveness in preventing the removal of invasive monitoring devices (such as endotracheal tubes, central lines, feeding tubes, etc.) compared with the current standard of care, wrist restraints.
Detailed description
This randomized controlled trial's primary purpose is to determine the efficacy of the HEALiX compared with wrist restraints in the adult, intubated patient in the critical care and intermediate care setting. The study's secondary purpose is to understand the acceptability of the HEALiX from healthcare professionals' perspective providing care at the bedside. By recruiting participants for use in the HEALiX RCT study and using the HEALiX with patients during care, the PI will gather information regarding the comparative effectiveness of the HEALiX in a population of critical care patients. This RCT trial will use a quantitative, comparative approach using an experimental and control study group design to measure and compare the outcomes after the subjects are placed in either the HEALiX or wrist restraints.
The setting for the HEALiX Pilot Study will be Penn State Hershey Medical Center in Hershey Pennsylvania. The specific location for the trial will be in several of the academic medical center's critical care units, including Heart and Vascular ICU (HVICU), Surgical Anesthesia ICU (SICU), Neurosurgical Intensive Care Unit (NSICU), and Medical Intensive Care Unit (MICU). Key nursing unit leaders and leaders from other service lines whose clinical input was essential to contribute to this RCT trial's success gave permission to conduct this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This randomized control trial will use a quantitative, comparative approach using an experimental and control study group design to measure and compare the outcomes after the subjects are placed in either the HEALiX or wrist restraints.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: HEALiX is an alternative restraint patient safety deviceParticipants will wear HEALiX Device while intubated and sedated in the critical care setting |
| Control | Active comparator | Device: soft wrist restraintsParticipants will wear wrist restraints while intubated and sedated in the critical care setting |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Mechanically ventilated (with or without tracheostomy)
- Receiving analgesic-sedating medications
- Wearing soft wrist restraints
- Glasgow Coma Scale score > 8
- Participants must be between ages 18-89 years old
Key exclusion criteria (5 listed)
- Children (under age 18)
- Pregnant women
- Cognitively impaired adults (must be able to follow commands)
- Prisoners
- Combative patients
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 |
|---|---|---|
| HEALiX is an alternative restraint patient safety deviceThe HEALiX is a rigid, spiral, exoskeleton-like device made of lightweight stainless steel (Austenitic SAE 316 or equivalent) that comes in various sizes to fit different arm lengths circumference of the patient's bicep. After appropriate measuring and following the fit guide, the HEALiX is placed on the patient's arm so that the hand rests on a soft, padded hand cradle. The trajectory of the end hand cradle is at a 30-degree upward angle to prevent peripheral dependent edema. This hand cradle is surrounded by foam to provide increased support for the patient and also to protect the medical team from any injury. A wrist bracelet (wrist assist) goes around the patient's wrist and prevents the patient from removing the device. The spiral exoskeleton holds the arm in a neutral position with contact points with the patient's skin at the upper deltoid region only. | Device | Experimental |
| soft wrist restraintsSoft wrist restraints are padded cloth restraints that are worn by patients on wrist and secured to bed frame. | Device | Control |
Primary outcome
Unplanned removal of devices
Time frame: End of intubation (average 7 days)
Frequency of unplanned removal of lines and self-extubation
6 secondary outcomes
Ease of device use
Time frame: End of intubation (average 7 days)
Days on the ventilator that each patient group remains
Time frame: End of intubation (average 7 days)
Number of days in the ICU that each patient group remains
Time frame: End of ICU stay when patient is transferred to lower level of care (average 10 days)
Fentanyl Dosing
Time frame: 1 Day
Propofol Dosing
Time frame: 1 Day
Midazolam Dosing
Time frame: 1 Day
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 18 Dec 2024.
- Background: PubMed 28243012Arumugam S, El-Menyar A, Al-Hassani A, Strandvik G, Asim M, Mekkodithal A, Mudali I, Al-Thani H. Delirium in the Intensive Care Unit. J Emerg Trauma Shock. 2017 Jan-Mar;10(1):37-46. doi: 10.4103/0974-2700.199520.
- Background: PubMed 29977877Balci H, Arslan S. Nurses' Information, Attitude and Practices towards Use of Physical Restraint in Intensive Care Units. J Caring Sci. 2018 Jun 1;7(2):75-81. doi: 10.15171/jcs.2018.012. eCollection 2018 Jun.
- Background: PubMed 29170870Burry L, Rose L, Ricou B. Physical restraint: time to let go. Intensive Care Med. 2018 Aug;44(8):1296-1298. doi: 10.1007/s00134-017-5000-0. Epub 2017 Nov 23. No abstract available.
- Background: PubMed 25488757Jiang H, Li C, Gu Y, He Y. Nurses' perceptions and practice of physical restraint in China. Nurs Ethics. 2015 Sep;22(6):652-60. doi: 10.1177/0969733014557118. Epub 2014 Dec 8.
- Background: PubMed 26652790Johnson K, Curry V, Steubing A, Diana S, McCray A, McFarren A, Domb A. A non-pharmacologic approach to decrease restraint use. Intensive Crit Care Nurs. 2016 Jun;34:12-9. doi: 10.1016/j.iccn.2015.08.004. Epub 2015 Dec 1.
- Background: PubMed 28388984Kwon E, Choi K. Case-control Study on Risk Factors of Unplanned Extubation Based on Patient Safety Model in Critically Ill Patients with Mechanical Ventilation. Asian Nurs Res (Korean Soc Nurs Sci). 2017 Mar;11(1):74-78. doi: 10.1016/j.anr.2017.03.004. Epub 2017 Mar 25.
- Background: PubMed 26820185Lach HW, Leach KM, Butcher HK. Evidence-Based Practice Guideline: Changing the Practice of Physical Restraint Use in Acute Care. J Gerontol Nurs. 2016 Feb;42(2):17-26. doi: 10.3928/00989134-20160113-04.
- Background: PubMed 28993046LeBlanc A, Bourbonnais FF, Harrison D, Tousignant K. The experience of intensive care nurses caring for patients with delirium: A phenomenological study. Intensive Crit Care Nurs. 2018 Feb;44:92-98. doi: 10.1016/j.iccn.2017.09.002. Epub 2017 Oct 6.
- Background: PubMed 29280605Perez D, Peters K, Wilkes L, Murphy G. PHYSICAL RESTRAINTS IN INTENSIVE CARE: EXPERIENCES OF PATIENTS, FAMILIES AND NURSES. Aust Nurs Midwifery J. 2017 May;24(10):45.
- Background: PubMed 27871314Rose L, Dale C, Smith OM, Burry L, Enright G, Fergusson D, Sinha S, Wiesenfeld L, Sinuff T, Mehta S. A mixed-methods systematic review protocol to examine the use of physical restraint with critically ill adults and strategies for minimizing their use. Syst Rev. 2016 Nov 21;5(1):194. doi: 10.1186/s13643-016-0372-8.
- Background: PubMed 31215614Souza LMDS, Santana RF, Capeletto CDSG, Menezes AK, Delvalle R. Factors associated with mechanical restraint in the hospital environment: a cross-sectional study. Rev Esc Enferm USP. 2019 Jun 13;53:e03473. doi: 10.1590/S1980-220X2018007303473. English, Portuguese.
- Background: PubMed 27553206Staggs VS, Olds DM, Cramer E, Shorr RI. Nursing Skill Mix, Nurse Staffing Level, and Physical Restraint Use in US Hospitals: a Longitudinal Study. J Gen Intern Med. 2017 Jan;32(1):35-41. doi: 10.1007/s11606-016-3830-z. Epub 2016 Aug 23.
- Individual participant dataSharing planned: No. Plan to publish in multiple nursing journals and attend research conferences.
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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.
Eliessa Caplan, DNP principal investigator
Milton S. Hershey Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing HEALiX is an alternative restraint patient safety device and soft wrist restraints in people with Safety Issues and Device Dislodgement, run by Milton S. Hershey Medical Center.
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 8 inclusion and 5 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 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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: End of intubation (average 7 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05180552, which also lists 13 linked publications.
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 18 Dec 2024.