NCT04550871

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Autonomous Healthcare, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2021-07-21
• Primary completion: 2022-08-30
• Completion: 2022-12-31
• First posted: 2020-09-16
• Last updated: 2022-05-31

Locations

1 site across 1 country: United States