Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Novel Arm Restraint For Critically Ill Patients To Reduce Immobility, Sedation, Agitation and Cognitive Impairment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04067622
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : September 7, 2020
Sponsor:
Collaborators:
Johns Hopkins University
University of California, San Diego
Healthy Design, LLC
Information provided by (Responsible Party):
Renee Stapleton, University of Vermont

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Respiratory Failure Encephalopathy ARDS Sepsis Critical Illness Device: Exersides Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Within-patient, randomized crossover design.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Novel Arm Restraint For Critically Ill Patients To Reduce Immobility, Sedation, Agitation and Cognitive Impairment
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : November 1, 2021

Arm Intervention/treatment
Exersides restraints first
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.
Device: Exersides
A novel arm restraint which permits arm mobility but prohibits hands from reaching oral/nasal endotracheal and feeding tubes or intravenous lines.

Traditional restraints first
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.
Device: Exersides
A novel arm restraint which permits arm mobility but prohibits hands from reaching oral/nasal endotracheal and feeding tubes or intravenous lines.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Sedation/Agitation [ Time Frame: Baseline, every 60 minutes on study days 1-2, every 4 hours on study days 3-6 ]
    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).

  2. Delirium [ Time Frame: Baseline, every 4 hours days 1-2, twice daily days 3-6 ]
    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.

  3. Average cumulative dose of sedative medications [ Time Frame: Up to 6 days ]
    Cumulative use of sedative medications over the 6 day study period

  4. Average cumulative dose of analgesic medications [ Time Frame: Up to 6 days ]
    Cumulative use of analgesics over the 6 day study period

  5. Average cumulative dose of antipsychotic medications [ Time Frame: Up to 6 days ]
    Cumulative use of antipsychotics over the 6 day study period


Other Outcome Measures:
  1. Satisfaction with novel restraint (nurses, family, physicians, and patients when able) [ Time Frame: Up to 6 days ]
    Satisfaction and acceptability will be assessed by the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) survey. The QUEST 2.0 is a valid, reliable, and widely used 12-question survey assessing satisfaction with technological devices. It is scored from 1-5, with >3.26 considered high satisfaction. The QUEST 2.0 has 2 subscales (satisfaction with device and with services). Satisfaction with the Exersides restraint will be assessed using the device subscale, which has good test-retest stability (ICC 0.82).

  2. Acceptability of novel restraint (nurses, family, physicians, and patients when able) [ Time Frame: Up to 6 days ]
    Acceptability will be assessed with semi-structured interviews using open-ended questions



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥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

Exclusion Criteria:

  • 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
  • Incarcerated
  • Pregnant
  • Attending physician declines patient enrollment
  • LAR unavailable to consent (and patient is unable to consent)
  • Patient or LAR decline consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04067622


Contacts
Layout table for location contacts
Contact: Sara Ardren 802-656-7953 sara.ardren@med.uvm.edu
Contact: Stephanie Burns 802-656-8307 stephanie.burns@uvmhealth.org

Locations
Layout table for location information
United States, California
University of California San Diego Recruiting
San Diego, California, United States, 92093
Contact: Leander Lazaro       llazaro@ucsd.edu   
Principal Investigator: Biren Kamdar, MD         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21218
Contact: Arooj Fatima       afatima1@jhmi.edu   
Principal Investigator: Dale Needham, MD, PhD         
United States, Vermont
University of Vermont Recruiting
Burlington, Vermont, United States, 05405
Contact: Sara Ardren    802-656-7953    sara.ardren@med.uvm.edu   
Contact: Stephanie Burns    802-656-8307    stephanie.burns@uvmhealth.org   
Principal Investigator: Renee Stapleton, MD, PhD         
Sponsors and Collaborators
University of Vermont
Johns Hopkins University
University of California, San Diego
Healthy Design, LLC
Investigators
Layout table for investigator information
Principal Investigator: Renee Stapleton, MD, PhD University of Vermont
Principal Investigator: Dale Needham, MD, PhD Johns Hopkins University
Layout table for additonal information
Responsible Party: Renee Stapleton, Professor of Medicine, University of Vermont
ClinicalTrials.gov Identifier: NCT04067622    
Other Study ID Numbers: CHRMS-18-0353
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: September 7, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Insufficiency
Brain Diseases
Critical Illness
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Disease Attributes
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Central Nervous System Diseases
Nervous System Diseases