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

NCT ID: NCT04550871

Last Updated: 2022-05-31

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-21
• Study Completion Date: 2022-12-31

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.

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.

Conditions

Respiratory Failure

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Autonomous Healthcare, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Northeast Georgia Medical Center

Gainesville, Georgia, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Brandon Powers

Role: primary

Geoffrey.Powers@nghs.com

770-219-8869

Other Identifiers

S-101

Identifier Type: -

Identifier Source: org_study_id