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

A Pilot Study Investigating the Detection of Episodes of Significant Patient-Ventilator Asynchrony in Mechanically Ventilated Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Respiratory Failure

Detailed Description

This is a prospective observational study. All decisions about ventilator settings, mode of ventilation, and sedative doses are determined by the critical care team attending to the patient. Patients will be enrolled within 6 hours after intubation and will be studied continuously until extubation. Patients will be monitored for asynchrony using Syncron-E tablets provided by Autonomous Healthcare. However, clinical staff will be blinded to the results of the tablet, and hence, there will be no change to clinical care.

Asynchrony index (which captures the fraction of breaths with asynchrony) will be calculated every minute by the Syncron-E tablet. The assessment of respiratory therapists at the time of ventilator checks will also be recorded including the following information: i) entering/exiting the room , ii) existence of a severe asynchrony episode based on the respiratory therapist's assessment and its type. Clinical staff will record the start of any severe asynchrony episode that they detect. Data related to the administrations of sedatives and anesthetics as well as major interventions (excluding any PHI) will also be recorded.

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Gainesville, Georgia, United States, 30501
      • Recruiting
      • Northeast Georgia Medical Center
      • Contact: Brandon Powers; Phone Number: 770-219-8869; Email: Geoffrey.Powers@nghs.com
      • Principal Investigator: Gagan Kumar, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Mechanically ventilated in the intensive care unit

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Any patient not meeting inclusion criteria.
• Any patient receiving muscle relaxant (paralytics) for more than 24 hours.
• Any patient receiving inverse ratio ventilation.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Autonomous Healthcare, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2021
• Primary Completion (Anticipated): August 30, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: September 3, 2020
• First Submitted That Met QC Criteria: September 9, 2020
• First Posted (Actual): September 16, 2020

Study Record Updates

• Last Update Posted (Actual): May 31, 2022
• Last Update Submitted That Met QC Criteria: May 25, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Patient-ventilator asynchrony
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: S-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No