Novel Arm Restraint in the Intensive Care Unit

Acute Respiratory Failure Clinical Trial

Official title:

Pilot Study of a Novel Arm Restraint For Critically Ill Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03621475
• Other study ID #: 18-0353-01
• Status: Completed
• Phase: Phase 1
• Start date: October 1, 2018
• Est. completion date: April 15, 2019

Study information

• Verified date: April 2021
• Source: University of Vermont
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: April 15, 2019
• Est. primary completion date: April 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• Novel restraint
Use of a novel arm restraint

Locations

Country	Name	City	State
United States	University of Vermont College of Medicine	Burlington	Vermont

Sponsors (2)

Lead Sponsor	Collaborator
University of Vermont	Healthy Design, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Severe Adverse Events [Safety]	Safety will be measured by <20% mean incidence across all of the following measures listed below (each listed as individual measure)	Through study day 2
Primary	Incidence of clinician or patient laceration	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.	Through study day 2
Primary	Incidence of pressure ulcer 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)	Through study day 2
Primary	Incidence of self-removal of novel restraint	Self-removal of novel restraint	Through study day 2
Primary	Incidence of damage to hospital bed rendering it non-functional	Any damage to hospital bed from restraint device rendering it non-functional	Through study day 2
Primary	incidence of damage to ICU equipment	Any damage to ICU equipment (e.g. ventilator) rendering it non-functional	Through study day 2
Secondary	Incidence of self-extubation	Will record instances where participants remove own endotracheal tube	Through study day 2
Secondary	Enrolling adequate number of patients	Demonstrate that conducting a future RCT is feasible by consent/recruitment into this study of 8 patients over 7 months	Study day 1
Secondary	Upper extremity mobility	Actigraphy counts as measured by Philliips actigraph, a device that records individual movements	Continuously through study day 2
Secondary	Sedation/agitation score	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)	Every hour through study day 2
Secondary	Delirium score	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.	Every 8 hours through study day 2
Secondary	Satisfaction with novel device	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).	Study day 2