A Pilot Study Investigating the Detection of Episodes of Severe Patient-Ventilator Asynchrony

NCT04550871 | Unknown

• 1 other identifier: S-101
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to determine what percent of severe patient-ventilator asynchrony is detected in mechanically ventilated patients in the adult ICU and to determine delays in detecting those asynchronies by the staff that were correctly identified, and whether asynchrony status recorded during intermittent assessments by respiratory therapists is representative of periods in between such assessments.

Conditions

Respiratory Failure

Keywords

Patient-ventilator asynchrony

Outcome Measures

Primary Outcomes (1)

• Number of asynchrony events per minute and the asynchrony index

  The endpoints will be calculated starting from the end of each ventilator check (when the respiratory therapist is leaving the room) and cover the time from that time point until 5-minutes prior to the next ventilator check event. The endpoints will also be separately calculated for the 5-minute period immediately preceding the next ventilator check.

  Up to 4 weeks

Secondary Outcomes (2)

• Time difference between when the Syncron-E tablet detects the start of severe asynchrony episodes and when the clinician-detects the start of severe asynchrony episodes

  Up to 4 weeks

• Number of Syncron-E tablet-detected severe asynchrony episodes that went undetected by clinicians and the number of clinician-detected severe asynchrony episodes undetected by Syncron-E tablet

  Up to 4 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Mechanically ventilated in the intensive care unit

You may qualify if:

• Patients requiring intensive care unit admission
• Patients requiring invasive mechanical ventilation expected to last more than 24 hours
• Patients ventilated on PCV, PSV, VCV, or VC+ ventilation modes

You may not qualify if:

• Any patient receiving muscle relaxant (paralytics) for more than 24 hours.
• Any patient receiving inverse ratio ventilation.

Sponsors & Collaborators

• Autonomous Healthcare, Inc.: lead

Study Sites (1)

Northeast Georgia Medical Center

Gainesville, Georgia, 30501, United States

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency; Patient-Ventilator Asynchrony

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: September 16, 2020
• Study Start: July 21, 2021
• Primary Completion: August 30, 2022
• Study Completion: December 31, 2022
• Last Updated: May 31, 2022

Record last verified: 2022-05

Locations

US (1)