Acute Respiratory FailureNCT04067622
Novel Arm Restraint For Critically Ill Patients To Reduce Immobility, Sedation, Agitation and Cognitive Impairment
A study testing Exersides in people with Acute Respiratory Failure and Encephalopathy, run by University of Vermont at 3 sites in United States.
Trial summary
This study evaluates a novel arm restraint compared with traditional soft wrist restraints in older critically ill patients. The primary outcome is upper extremity mobility measured by actigraphy, and secondary outcomes include sedation, agitation, satisfaction, and acceptability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure, Encephalopathy, ARDS
- What is being tested?
- Exersides
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Sep 2019to 28 Dec 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years old
- Requiring ICU care
- Requiring wrist or mitt restraints and has active physician order
- Expected ICU stay ≥2 days after enrollment
- Responsive to verbal stimulus
Who cannot join
- Bilateral upper extremity impairments (e.g. arm injuries) or problems (e.g. severe skin breakdown) that prevent use of novel restraint device. Normal use of one arm (e.g. unilateral upper extremity amputation) is acceptable.
- Very limited mobility of bilateral upper extremities prior to admission (e.g. bilateral frozen shoulders). Normal use of one arm is acceptable.
- Pre-existing severe neuromuscular condition inhibiting or axacerbating upper extremity movement (e.g. Guillain-Barre, severe tremor, myoclonus)
- 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
Show all 11Show fewer
- Incarcerated
- Pregnant
- Attending physician declines patient enrollment
- LAR unavailable to consent (and patient is unable to consent)
- Patient or LAR decline consent
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Johns Hopkins University
Baltimore, Maryland, 21218
University of Vermont
Burlington, Vermont, 05405
University of California San Diego
San Diego, California, 92093
About this study
This study evaluates a novel arm restraint compared with traditional soft wrist restraints in older critically ill patients. The primary outcome is upper extremity mobility measured by actigraphy, and secondary outcomes include sedation, agitation, satisfaction, and acceptability.
Read the detailed description
The goal of this Fast-Track STTR project is to optimize and test a novel arm restraint in older critically ill patients that increases mobility; reduces agitation, use of sedative medications, and delirium; and exhibits high satisfaction and acceptability among hospital staff, family members, and patients. Older critically ill patients are often immobilized with wrist restraints to prevent self-removal of tubes and lines 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 is developing the novel ExersidesTM restraint that allows arm mobility but prohibits hands from reaching oral/nasal endotracheal and feeding tubes or intravenous lines. Because it permits mobility, ExersidesTM may reduce agitation and the need for sedatives. In preliminary pilot testing, ExersidesTM has demonstrated very encouraging results. The objectives of this STTR Fast-Track project are to optimize ExersidesTM and evaluate it in a randomized controlled trial (RCT) in older critically ill patients at high risk for delirium and associated long-term cognitive impairment. The multidisciplinary investigator team has expertise in critical care, extensive experience in conducting ICU RCTs, and a history of successful collaboration.
Phase I of the STTR, during which the novel restraint device was modified based on feedback from healthy volunteers and a single-center prospective pilot study was performed in 8 older patients with acute respiratory failure, has already been completed. The Phase I pilot study has demonstrated that 1) the revised ExersidesTM prototype is safe and 2) the RCT proposed in Phase II is feasible.
Therefore, Phase II of the STTR will now occur. In Phase II, a multi-site within-patient crossover RCT in older critically ill patients requiring restraint will be conducted to test the following outcomes in ExersidesTM versus traditional wrist restraint: 1) Mobility assessed by actigraphy (primary outcome); 2) Agitation, delirium, and medication use (secondary outcomes); and 3) Satisfaction with and acceptability/perceptions of the device (secondary outcomes). Successful completion of this project will result in an ExersidesTM restraint that is ready for final optimization in preparation for commercialization, and is suitable for larger clinical studies to demonstrate effectiveness reducing long-term cognitive impairment in older ICU patients.
- Conditions
- Acute Respiratory Failure, Encephalopathy, ARDS, Sepsis, Critical Illness
- Being tested
- Exersides
- Medical subject headings
- Brain Diseases, Sepsis, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExersidesDevice
A novel arm restraint which permits arm mobility but prohibits hands from reaching oral/nasal endotracheal and feeding tubes or intravenous lines.
| Study group | Role | What they receive |
|---|---|---|
| Exersides restraints first | Other | Patients in this arm will wear the novel Exersides restraint during hours 1-4 on Day 1, then switched to soft wrist restrains during hours 5-8. On Day 2, patients in this arm will will wear soft wrist restraints during hours 1-4, and Exersides during hours 5-8. They will then wear Exersides during study days 3-6. Receives: Device: Exersides |
| Traditional restraints first | Other | Patients in this arm will wear soft wrist restraints during hours 1-4 on Day 1; they will then be switched to the novel Exersides restraint during hours 5-8. On Day 2, patients in this arm will will wear Exersides during hours 1-4, and soft wrist restraints during hours 5-8. They will then wear soft wrist restraints during study days 3-6. Receives: Device: Exersides |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mobility assessed by actigraphy
Upper extremity mobility will be evaluated by actigraphy. The Philips Respironics Spectrum Plus® actigraph is a commercially-available actigraphy device weighing 16 grams. It contains a battery-powered activity monitor and uses a highly sensitive accelerometer to monitor the occurrence and degree of motion. Only patients who wear both the novel restraint and traditional soft wrist restraints for at least 4 hours each will be included in the primary analysis.
Measured: Up to 6 days
Secondary outcomes (5)
Sedation/Agitation
Agitation will be measured via RASS (Richmond Agitation Sedation Scale) score. RASS is a validated and reliable ordinal measure of sedation/agitation status in the ICU ranging from -5 (extremely sedated, no response to voice or physical stimulation) to +4 (extremely agitated, violent, combative).
Measured: Baseline, every 60 minutes on study days 1-2, every 4 hours on study days 3-6
Delirium
Delirium will be measured via CAM-ICU (Confusion Assessment Method for the ICU). The CAM-ICU score is a validated and reliable binary measure of delirium status in the ICU. A "yes" score means delirium is present, and a "no score means delirium is absent.
Measured: Baseline, every 4 hours days 1-2, twice daily days 3-6
Average cumulative dose of sedative medications
Cumulative use of sedative medications over the 6 day study period
Measured: Up to 6 days
Average cumulative dose of analgesic medications
Cumulative use of analgesics over the 6 day study period
Measured: Up to 6 days
Average cumulative dose of antipsychotic medications
Cumulative use of antipsychotics over the 6 day study period
Measured: Up to 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start1 Sep 2019
- Primary completion24 Dec 2021
- Study completion28 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Within-patient, randomized crossover design.
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, University of California, San Diego, Healthy Design, LLC
- Responsible party
- Principal investigator, Renee Stapleton, University of Vermont
- Investigators
- Renee Stapleton, MD, PhD, Principal investigator, University of VermontDale Needham, MD, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04067622
- Sponsor's protocol ID
- CHRMS-18-0353
- Status last verified
- Mar 2022
- First submitted
- 20 Aug 2019
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Arm Restraint For Critically Ill Patients To Reduce Immobility, Sedation, Agitation and Cognitive Impairment
- ClinicalTrials.gov ID
- NCT04067622
- Acronym / sponsor ID
- CHRMS-18-0353
- Conditions
- Acute Respiratory Failure, Encephalopathy, ARDS, Sepsis, Critical Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- Johns Hopkins University, University of California, San Diego, Healthy Design, LLC
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 24 Dec 2021 (actual)
- Study completion
- 28 Dec 2021 (actual)
- First posted
- 26 Aug 2019 (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.
This study evaluates a novel arm restraint compared with traditional soft wrist restraints in older critically ill patients. The primary outcome is upper extremity mobility measured by actigraphy, and secondary outcomes include sedation, agitation, satisfaction, and acceptability.
Detailed description
The goal of this Fast-Track STTR project is to optimize and test a novel arm restraint in older critically ill patients that increases mobility; reduces agitation, use of sedative medications, and delirium; and exhibits high satisfaction and acceptability among hospital staff, family members, and patients. Older critically ill patients are often immobilized with wrist restraints to prevent self-removal of tubes and lines 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 is developing the novel ExersidesTM restraint that allows arm mobility but prohibits hands from reaching oral/nasal endotracheal and feeding tubes or intravenous lines. Because it permits mobility, ExersidesTM may reduce agitation and the need for sedatives. In preliminary pilot testing, ExersidesTM has demonstrated very encouraging results. The objectives of this STTR Fast-Track project are to optimize ExersidesTM and evaluate it in a randomized controlled trial (RCT) in older critically ill patients at high risk for delirium and associated long-term cognitive impairment. The multidisciplinary investigator team has expertise in critical care, extensive experience in conducting ICU RCTs, and a history of successful collaboration.
Phase I of the STTR, during which the novel restraint device was modified based on feedback from healthy volunteers and a single-center prospective pilot study was performed in 8 older patients with acute respiratory failure, has already been completed. The Phase I pilot study has demonstrated that 1) the revised ExersidesTM prototype is safe and 2) the RCT proposed in Phase II is feasible.
Therefore, Phase II of the STTR will now occur. In Phase II, a multi-site within-patient crossover RCT in older critically ill patients requiring restraint will be conducted to test the following outcomes in ExersidesTM versus traditional wrist restraint: 1) Mobility assessed by actigraphy (primary outcome); 2) Agitation, delirium, and medication use (secondary outcomes); and 3) Satisfaction with and acceptability/perceptions of the device (secondary outcomes). Successful completion of this project will result in an ExersidesTM restraint that is ready for final optimization in preparation for commercialization, and is suitable for larger clinical studies to demonstrate effectiveness reducing long-term cognitive impairment in older ICU patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Within-patient, randomized crossover design.
| Arm | Type | Receives |
|---|---|---|
| Exersides restraints first | Other | Device: ExersidesPatients in this arm will wear the novel Exersides restraint during hours 1-4 on Day 1, then switched to soft wrist restrains during hours 5-8. On Day 2, patients in this arm will will wear soft wrist restraints during hours 1-4, and Exersides during hours 5-8. They will then wear Exersides during study days 3-6. |
| Traditional restraints first | Other | Device: ExersidesPatients in this arm will wear soft wrist restraints during hours 1-4 on Day 1; they will then be switched to the novel Exersides restraint during hours 5-8. On Day 2, patients in this arm will will wear Exersides during hours 1-4, and soft wrist restraints during hours 5-8. They will then wear soft wrist restraints during study days 3-6. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥18 years old
- Requiring ICU care
- Requiring wrist or mitt restraints and has active physician order
- Expected ICU stay ≥2 days after enrollment
- Responsive to verbal stimulus
Key exclusion criteria (11 listed)
- Bilateral upper extremity impairments (e.g. arm injuries) or problems (e.g. severe skin breakdown) that prevent use of novel restraint device. Normal use of one arm (e.g. unilateral upper extremity amputation) is acceptable.
- Very limited mobility of bilateral upper extremities prior to admission (e.g. bilateral frozen shoulders). Normal use of one arm is acceptable.
- Pre-existing severe neuromuscular condition inhibiting or axacerbating upper extremity movement (e.g. Guillain-Barre, severe tremor, myoclonus)
- 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 |
|---|---|---|
| ExersidesA novel arm restraint which permits arm mobility but prohibits hands from reaching oral/nasal endotracheal and feeding tubes or intravenous lines. | Device | Exersides restraints first, Traditional restraints first |
Primary outcome
Mobility assessed by actigraphy
Time frame: Up to 6 days
Upper extremity mobility will be evaluated by actigraphy. The Philips Respironics Spectrum Plus® actigraph is a commercially-available actigraphy device weighing 16 grams. It contains a battery-powered activity monitor and uses a highly sensitive accelerometer to monitor the occurrence and degree of motion. Only patients who wear both the novel restraint and traditional soft wrist restraints for at least 4 hours each will be included in the primary analysis.
5 secondary outcomes
Sedation/Agitation
Time frame: Baseline, every 60 minutes on study days 1-2, every 4 hours on study days 3-6
Delirium
Time frame: Baseline, every 4 hours days 1-2, twice daily days 3-6
Average cumulative dose of sedative medications
Time frame: Up to 6 days
Average cumulative dose of analgesic medications
Time frame: Up to 6 days
Average cumulative dose of antipsychotic medications
Time frame: Up to 6 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
- 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.
Renee Stapleton, MD, PhD principal investigator
University of Vermont
Dale Needham, MD, PhD principal investigator
Johns Hopkins University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exersides in people with Acute Respiratory Failure and Encephalopathy, run by University of Vermont at 3 sites 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 11 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 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mobility assessed by actigraphy (time frame: Up to 6 days). 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 10 Mar 2022.