An observational study in Respiratory Failure, sponsored by Autonomous Healthcare, Inc.. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-31.
Sponsored by Autonomous Healthcare, Inc. · Observational
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.
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.
24 studies on the registry are indexed under Patient-Ventilator Asynchrony; 11 are open to participants now.
This study's planned enrollment of 30 is below the median of 40 across 13 observational studies indexed under Patient-Ventilator Asynchrony.
Browse Patient-Ventilator Asynchrony studies →Autonomous Healthcare, Inc. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Compared within Patient-Ventilator Asynchrony, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Respiratory Insufficiency. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Mechanically ventilated in the intensive care unit
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Exclusion Criteria:
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.
Time frame: Up to 4 weeks
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
Time frame: 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
Time frame: Up to 4 weeks
Started Jul 2021 (actual). Primary completion is estimated for Aug 2022, 13 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Patient-Ventilator Asynchrony →
Autonomous Healthcare, Inc.