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 in the Intensive Care Unit

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03621475
Recruitment Status : Active, not recruiting
First Posted : August 8, 2018
Last Update Posted : September 7, 2020
Sponsor:
Collaborator:
Healthy Design, LLC
Information provided by (Responsible Party):
Renee Stapleton, University of Vermont

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Respiratory Failure Device: Novel restraint Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pilot Study of a Novel Arm Restraint For Critically Ill Patients
Actual Study Start Date : October 1, 2018
Actual Primary Completion Date : April 11, 2019
Estimated Study Completion Date : March 15, 2021

Arm Intervention/treatment
Experimental: Novel restraint first, then traditional restraint
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.
Device: Novel restraint
Use of a novel arm restraint

Experimental: Traditional restraint first, then novel restraint
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.
Device: Novel restraint
Use of a novel arm restraint




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Severe Adverse Events [Safety] [ Time Frame: Through study day 2 ]
    Safety will be measured by <20% mean incidence across all of the following measures listed below (each listed as individual measure)

  2. Incidence of clinician or patient laceration [ 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.

  3. Incidence of pressure ulcer 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)

  4. Incidence of self-removal of novel restraint [ Time Frame: Through study day 2 ]
    Self-removal of novel restraint

  5. Incidence of damage 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

  6. incidence of damage to ICU equipment [ Time Frame: Through study day 2 ]
    Any damage to ICU equipment (e.g. ventilator) rendering it non-functional


Secondary Outcome Measures :
  1. Incidence of self-extubation [ Time Frame: Through study day 2 ]
    Will record instances where participants remove own endotracheal tube

  2. Enrolling adequate number of patients [ Time Frame: Study day 1 ]
    Demonstrate that conducting a future RCT is feasible by consent/recruitment into this study of 8 patients over 7 months

  3. Upper extremity mobility [ Time Frame: Continuously through study day 2 ]
    Actigraphy counts as measured by Philliips actigraph, a device that records individual movements

  4. Sedation/agitation score [ Time Frame: Every hour through study day 2 ]
    Agitation measured by the Richmond agitation sedation score [RASS] every hour while wearing restraints. This score measures sedation and agitation from a scale of -5 (most sedated) to +4 (most agitated)

  5. Delirium score [ Time Frame: Every 8 hours through study day 2 ]
    Delirium measured Confusion assessment method-ICU (CAM-ICU) delirium score every 4 hours. This score is binary (i.e., delirium yes/no) based on answers to 4 questions.

  6. Satisfaction with novel device [ Time Frame: Study day 2 ]
    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).



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:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. >65 years old
  2. Physician order for use of bilateral wrist restraints
  3. Requiring mechanical ventilation with actual or expected total duration of >48 hours
  4. Expected ICU stay >3 days after enrollment (to permit adequate exposure to proposed intervention)
  5. Not deeply sedated (Richmond Agitation Sedation Scale [RASS] score > -2)

Exclusion Criteria:

  1. Upper extremity impairments that prevent use of novel restraint device (e.g. amputation, arm injury)
  2. Limited mobility of either upper extremity prior to admission (e.g. frozen shoulder, severe arthritis)
  3. Pre-existing primary systemic neuromuscular disease (e.g. Guillain-Barre)
  4. Neuromuscular blocker infusion (eligible once infusion discontinued if other inclusion criteria met)
  5. Pre-existing severe cognitive impairment or language barrier prohibiting outcome assessment
  6. Expected death or withdrawal of life-sustaining treatments within 6 days from enrollment
  7. Incarcerated
  8. Severe skin breakdown on either upper extremity

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): NCT03621475


Locations
Layout table for location information
United States, Vermont
University of Vermont College of Medicine
Burlington, Vermont, United States, 05405
Sponsors and Collaborators
University of Vermont
Healthy Design, LLC
Layout table for additonal information
Responsible Party: Renee Stapleton, Associate Professor of Medicine, University of Vermont
ClinicalTrials.gov Identifier: NCT03621475    
Other Study ID Numbers: 18-0353-01
First Posted: August 8, 2018    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
Respiration Disorders
Respiratory Tract Diseases