Recruiting

Observational Study

Sponsor:

Autonomous Healthcare, Inc.

Code:

NCT04550871

Conditions

Respiratory Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT04550871

Start date

Jul 21, 2021

Status verified date

May, 2022

Completion date

Dec 31, 2022

Anticipated

Primary completion date

Aug 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Number of asynchrony events per minute and the asynchrony index [ Time Frame: Up to 4 weeks ]

Central Contacts and Locations

Locations

Northeast Georgia Medical Center

Recruiting

Gainesville, Georgia, United States, 30501

Contacts

Brandon Powers

770-219-8869Geoffrey.Powers@nghs.com

Principal Investigator:

Gagan Kumar, MD

More Information

Sponsor

Autonomous Healthcare, Inc.

Last update posted

May 31, 2022

Last verified

May, 2022

Keywords

  • Patient-ventilator asynchrony

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Autonomous Healthcare, Inc. on 2022-05-31.