Novel Arm Restraint in the Intensive Care Unit
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|ClinicalTrials.gov Identifier: NCT03621475|
Recruitment Status : Active, not recruiting
First Posted : August 8, 2018
Last Update Posted : September 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Acute Respiratory Failure||Device: Novel restraint||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||8 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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)
- 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.
- 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)
- Incidence of self-removal of novel restraint [ Time Frame: Through study day 2 ]Self-removal of novel restraint
- 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
- incidence of damage to ICU equipment [ Time Frame: Through study day 2 ]Any damage to ICU equipment (e.g. ventilator) rendering it non-functional
- Incidence of self-extubation [ Time Frame: Through study day 2 ]Will record instances where participants remove own endotracheal tube
- 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
- Upper extremity mobility [ Time Frame: Continuously through study day 2 ]Actigraphy counts as measured by Philliips actigraph, a device that records individual movements
- 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)
- 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.
- 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).
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
|United States, Vermont|
|University of Vermont College of Medicine|
|Burlington, Vermont, United States, 05405|