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

Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04550871
• Other study ID #: S-101
• Status: Recruiting
• Start date: July 21, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2022
• Source: Autonomous Healthcare, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Locations

Country	Name	City	State
United States	Northeast Georgia Medical Center	Gainesville	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Autonomous Healthcare, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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