Acute Respiratory FailurePhase 1NCT03621475
Novel Arm Restraint in the Intensive Care Unit
A Phase 1 study testing Novel restraint in people with Acute Respiratory Failure, run by University of Vermont at 1 site in United States.
Trial summary
The goal of this pilot is to evaluate a novel restraint device in 8 older mechanically ventilated patients to demonstrate that 1) the revised novel restraint prototype is safe and 2) a future randomized controlled trial (RCT) is feasible. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- Novel restraint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 15 Apr 2019
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- >65 years old
- Physician order for use of bilateral wrist restraints
- Requiring mechanical ventilation with actual or expected total duration of >48 hours
- Expected ICU stay >3 days after enrollment (to permit adequate exposure to proposed intervention)
- Not deeply sedated (Richmond Agitation Sedation Scale [RASS] score > -2)
Who cannot join
- Upper extremity impairments that prevent use of novel restraint device (e.g. amputation, arm injury)
- Limited mobility of either upper extremity prior to admission (e.g. frozen shoulder, severe arthritis)
- Pre-existing primary systemic neuromuscular disease (e.g. Guillain-Barre)
- Neuromuscular blocker infusion (eligible once infusion discontinued if other inclusion criteria met)
- Pre-existing severe cognitive impairment or language barrier prohibiting outcome assessment
- Expected death or withdrawal of life-sustaining treatments within 6 days from enrollment
- Incarcerated
- Severe skin breakdown on either upper extremity
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Vermont College of Medicine
Burlington, Vermont, 05405
About this study
Official title: Pilot Study of a Novel Arm Restraint For Critically Ill Patients
The goal of this pilot is to evaluate a novel restraint device in 8 older mechanically ventilated patients to demonstrate that 1) the revised novel restraint prototype is safe and 2) a future randomized controlled trial (RCT) is feasible.
Read the detailed description
The goal of this Fast-Track Small Business Technology Transfer (STTR) project is to optimize and test a novel arm restraint in older critically ill mechanically ventilated patients that may increase mobility; reduce agitation, use of sedative medications, and delirium; and exhibit high satisfaction and acceptability among hospital staff, family members, and patients. Older mechanically ventilated patients are often immobilized with wrist restraints to prevent self-extubation and are sedated to reduce agitation caused by their restraints and endotracheal (breathing) tube. This sedation and immobility lead to complications, including delirium and muscle weakness, that are independently associated with long term cognitive impairment, reduced physical functioning, and mortality. Specifically, the incidence and duration of delirium in the ICU are strongly and independently associated with long-term cognitive impairment that is similar to Alzheimer's Disease and Related Dementias.
Healthy Design has developed a novel restraint device that allows arm mobility but prohibits hands from reaching oral/nasal endotracheal and feeding tubes or intravenous lines. Because it permits mobility, the novel restraint may reduce agitation and the need for sedatives. The objectives of this pilot study are to evaluate the novel restraint in 8 older mechanically ventilated patients to demonstrate that 1) the revised novel restraint prototype is safe and 2) a future RCT is feasible.
- Conditions
- Acute Respiratory Failure
- Being tested
- Novel restraint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel restraintDevice
Use of a novel arm restraint
| Study group | Role | What they receive |
|---|---|---|
| Novel restraint first, then traditional restraint | Experimental | Participants will be randomized to wear the novel arm restraint bilaterally for 4 hours on study day #1, followed by traditional soft bilateral wrist restraints for 4 hours. Then, on study day #2, they will wear both kinds of restraints in the opposite order. Receives: Device: Novel restraint |
| Traditional restraint first, then novel restraint | Experimental | Participants will be randomized to wear traditional soft bilateral wrist restraints for 4 hours on study day #1, followed by the novel arm restraint bilaterally for 4 hours. Then, on study day #2, they will wear both kinds of restraints in the opposite order. Receives: Device: Novel restraint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Treatment-Emergent Severe Adverse Events [Safety]
Safety will be measured by the number (i.e. < 1 in 5 participants had a treatment emergent safety event per their on study time) across all of the following measures listed below. Incidence does not have to be per person-year; in this case it is incidence of safety adverse event during the study period.
Measured: Through study day 2
Number of Clinician or Patient Lacerations
Grade 2b or higher skin laceration (per Skin Tear Audit Research [STAR] Skin Tear Classification System) in patient or clinician from any sharp edges of device. The STAR grading system ranges from grade 1a at best to 3 at worst. Each laceration is given an individual score based on appearance.
Measured: Through study day 2
Number of Pressure Ulcers From Device
Development of pressure ulcer from device of Stage 3 or greater per 2016 National Pressure Ulcer Advisory Panel Pressure Injury Stages. This staging system provides an individual score to each pressure ulcer based on appearance from stage 1 (best) to stage 4 (worst)
Measured: Through study day 2
Number of Self-removals of Novel Restraint
Self-removal of novel restraint
Measured: Through study day 2
Number of Damaging Events to Hospital Bed Rendering it Non-functional
Any damage to hospital bed from restraint device rendering it non-functional
Measured: Through study day 2
Number of Damaging Events to ICU Equipment
Any damage to ICU equipment (e.g. ventilator) rendering it non-functional
Measured: Through study day 2
Secondary outcomes (5)
Number of Self-extubations
Will record instances where participants remove own endotracheal tube
Measured: Through study day 2
Number of Movements of Upper Extremities
Actigraphy counts of upper extremities as measured by Philliips actigraph, a device that records individual movements
Measured: Continuously through study day 2
Richmond Agitation Sedation Score [RASS]
Agitation measured by the median of Richmond agitation sedation score [RASS] collected longitudinally every hour while wearing restraints. This score measures sedation and agitation from a scale of -5 (most sedated) to +4 (most agitated)
Measured: Median of multiple RASS scores collected over first 2 days of study period
Satisfaction With Novel Device as Assessed by the Quebec User Evaluation of Satisfaction With Assistive Technology (QUEST) Satisfaction Score
Satisfaction with the novel restraint device will be measured with the Quebec User Evaluation of Satisfaction with assistive Technology (QUEST) satisfaction tool. This 12-item questionnaire is scored from 1 (lowest satisfaction) to 5 (highest satisfaction).
Measured: Study day 2
Delerium Score
We intended to measure delirium score as accessed by the CAM-ICU. However, during the study we were unable to measure it because it was too often incorrectly charted by nursing. We therefore have nothing to report for this planned outcome.
Measured: 6-day study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start1 Oct 2018
- Primary completion11 Apr 2019
- Study completion15 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Respiratory FailureStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- Healthy Design, LLC
- Responsible party
- Principal investigator, Renee Stapleton, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03621475
- Sponsor's protocol ID
- 18-0353-01
- Status last verified
- Jan 2023
- First submitted
- 23 Jul 2018
- Last updated
- 29 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of a Novel Arm Restraint For Critically Ill Patients
- ClinicalTrials.gov ID
- NCT03621475
- Acronym / sponsor ID
- 18-0353-01
- Conditions
- Acute Respiratory Failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- Healthy Design, LLC
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 11 Apr 2019 (actual)
- Study completion
- 15 Apr 2019 (actual)
- First posted
- 8 Aug 2018 (actual)
- Results
- Posted 29 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this pilot is to evaluate a novel restraint device in 8 older mechanically ventilated patients to demonstrate that 1) the revised novel restraint prototype is safe and 2) a future randomized controlled trial (RCT) is feasible.
Detailed description
The goal of this Fast-Track Small Business Technology Transfer (STTR) project is to optimize and test a novel arm restraint in older critically ill mechanically ventilated patients that may increase mobility; reduce agitation, use of sedative medications, and delirium; and exhibit high satisfaction and acceptability among hospital staff, family members, and patients. Older mechanically ventilated patients are often immobilized with wrist restraints to prevent self-extubation and are sedated to reduce agitation caused by their restraints and endotracheal (breathing) tube. This sedation and immobility lead to complications, including delirium and muscle weakness, that are independently associated with long term cognitive impairment, reduced physical functioning, and mortality. Specifically, the incidence and duration of delirium in the ICU are strongly and independently associated with long-term cognitive impairment that is similar to Alzheimer's Disease and Related Dementias.
Healthy Design has developed a novel restraint device that allows arm mobility but prohibits hands from reaching oral/nasal endotracheal and feeding tubes or intravenous lines. Because it permits mobility, the novel restraint may reduce agitation and the need for sedatives. The objectives of this pilot study are to evaluate the novel restraint in 8 older mechanically ventilated patients to demonstrate that 1) the revised novel restraint prototype is safe and 2) a future RCT is feasible.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Novel restraint first, then traditional restraint | Experimental | Device: Novel restraintParticipants will be randomized to wear the novel arm restraint bilaterally for 4 hours on study day #1, followed by traditional soft bilateral wrist restraints for 4 hours. Then, on study day #2, they will wear both kinds of restraints in the opposite order. |
| Traditional restraint first, then novel restraint | Experimental | Device: Novel restraintParticipants will be randomized to wear traditional soft bilateral wrist restraints for 4 hours on study day #1, followed by the novel arm restraint bilaterally for 4 hours. Then, on study day #2, they will wear both kinds of restraints in the opposite order. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- >65 years old
- Physician order for use of bilateral wrist restraints
- Requiring mechanical ventilation with actual or expected total duration of >48 hours
- Expected ICU stay >3 days after enrollment (to permit adequate exposure to proposed intervention)
- Not deeply sedated (Richmond Agitation Sedation Scale [RASS] score > -2)
Key exclusion criteria (8 listed)
- Upper extremity impairments that prevent use of novel restraint device (e.g. amputation, arm injury)
- Limited mobility of either upper extremity prior to admission (e.g. frozen shoulder, severe arthritis)
- Pre-existing primary systemic neuromuscular disease (e.g. Guillain-Barre)
- Neuromuscular blocker infusion (eligible once infusion discontinued if other inclusion criteria met)
- Pre-existing severe cognitive impairment or language barrier prohibiting outcome assessment
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 |
|---|---|---|
| Novel restraintUse of a novel arm restraint | Device | Novel restraint first, then traditional restraint, Traditional restraint first, then novel restraint |
Primary outcome
Number of Treatment-Emergent Severe Adverse Events [Safety]
Time frame: Through study day 2
Safety will be measured by the number (i.e. < 1 in 5 participants had a treatment emergent safety event per their on study time) across all of the following measures listed below. Incidence does not have to be per person-year; in this case it is incidence of safety adverse event during the study period.
Number of Clinician or Patient Lacerations
Time frame: Through study day 2
Grade 2b or higher skin laceration (per Skin Tear Audit Research [STAR] Skin Tear Classification System) in patient or clinician from any sharp edges of device. The STAR grading system ranges from grade 1a at best to 3 at worst. Each laceration is given an individual score based on appearance.
Number of Pressure Ulcers From Device
Time frame: Through study day 2
Development of pressure ulcer from device of Stage 3 or greater per 2016 National Pressure Ulcer Advisory Panel Pressure Injury Stages. This staging system provides an individual score to each pressure ulcer based on appearance from stage 1 (best) to stage 4 (worst)
Number of Self-removals of Novel Restraint
Time frame: Through study day 2
Self-removal of novel restraint
Number of Damaging Events to Hospital Bed Rendering it Non-functional
Time frame: Through study day 2
Any damage to hospital bed from restraint device rendering it non-functional
Number of Damaging Events to ICU Equipment
Time frame: Through study day 2
Any damage to ICU equipment (e.g. ventilator) rendering it non-functional
5 secondary outcomes
Number of Self-extubations
Time frame: Through study day 2
Number of Movements of Upper Extremities
Time frame: Continuously through study day 2
Richmond Agitation Sedation Score [RASS]
Time frame: Median of multiple RASS scores collected over first 2 days of study period
Satisfaction With Novel Device as Assessed by the Quebec User Evaluation of Satisfaction With Assistive Technology (QUEST) Satisfaction Score
Time frame: Study day 2
Delerium Score
Time frame: 6-day study period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Novel restraint in people with Acute Respiratory Failure, run by University of Vermont 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 8 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: finished, as of the sponsor's last update on 29 May 2025. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Treatment-Emergent Severe Adverse Events [Safety] (time frame: Through study day 2). The study lists 6 primary outcomes in all. 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 29 May 2025.