NCT04708509

Extubation Advisor: Initial Implementation and Evaluation of a Novel Extubation Clinical Decision Support Tool

Completed Phase 1 Results posted Last updated 15 May 2025

What this trial tests

Phase 1 trial testing Extubation Advisor in Airway Extubation in 31 participants. Completed in 13 January 2023.

Timeline

4 October 2021

Primary endpoint
13 January 2023

13 January 2023

Quick facts

Lead sponsor	Ottawa Hospital Research Institute
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	31
Start date	4 October 2021
Primary completion	13 January 2023
Estimated completion	13 January 2023
Sites	1 location across Canada

Drugs / interventions tested

• Extubation Advisor

Conditions studied

• Airway Extubation — all drugs for Airway Extubation →

Sponsor

Ottawa Hospital Research Institute

Who can join

18 and older, any sex, with Airway Extubation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Evaluate Feasibility of Enrolling and Consenting Greater Than 50% of Eligible Patients Primary · Upon study completion, 4 months after study initiation

Feasibility of patient enrolment and consent will be evaluated by determining if greater than 50% of eligible patients are enrolled and consented

Group	Value	95% CI
Intervention Arm	30

Evaluate Feasibility of Capturing Greater Than 75% of Wave Form Data Primary · Upon study completion, 4 months after study initiation

Feasibility of wave form data capture will be evaluated by determining if greater than 75% of the time, wave form data is captured

Group	Value	95% CI
Intervention Arm	68

Evaluate Feasibility of Generating and Delivering Greater Than 80% of Extubation Advisor Reports to the Attending Physician Primary · Upon study completion, 4 months after study initiation

Feasibility of Extubation Advisor report generation will be evaluated by determining if greater than 80% of the time, an extubation report is successfully generated and delivered to the attending physician

Group	Value	95% CI
Intervention Arm	55

Sponsor's own description

Expeditious, safe extubation is vitally important in the care of Intensive Care Unit (ICU) patients, as prolonged mechanical ventilation harms patients and failed extubation (i.e. re-intubation within 48 hrs) is associated with increased morbidity, mortality and costs. The urgent need to improve extubation failure is further highlighted by current observations suggesting that COVID-19 patients are at increased risk of both early and late extubation failure. The investigators previously found that decreased respiratory rate variability (indicative of reduced adaptability and/or increased stress) during Spontaneous Breathing Trials (SBTs) predicted extubation failure and outperformed the best available predictive indices. Combining this predictive analytic with standardized extubation readiness checklists and risk mitigation strategies, the investigators created the Extubation Advisor (EA). The investigators recently completed a single-center phase I mixed methods observational study (n=117) wherein there was demonstrated technical feasibility (i.e. ability to generate 92% EA of reports) and clinician acceptance of the EA tool. In the current open-label, multi-center interventional phase I study, the investigators will assess the feasibility and initial perceptions of EA implementation in the intensive care unit by (1) evaluating the feasibility of patient enrolment, data collection, and EA report generation, and (2) performing a mixed-methods analysis of critical care physician and respiratory therapist perceptions of EA. Findings from this study will inform a future randomized controlled trial assessing EA outcomes compared to standard of care, with the intent of aiding bedside decision-making, enhancing care delivery, and improving outcomes in critically ill patients with and without COVID-19.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. <i>Extubation Advisor</i>: Implementation and Evaluation of A Novel Extubation Clinical Decision Support Tool.
   Hryciw BN, Hudek N, Brehaut JC, Herry C, et al · · 2025 · cited 1× · PMID 39444331 · DOI 10.1177/08850666241291524