Recruiting

Observational Study

Sponsor:

Unity Health Toronto

Code:

NCT06445049

Conditions

Reverse Triggering

Patient Ventilator Dyssynchrony

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

brief test

Study Details

Brief summary:

The goal of this study is to identify patients with reverse triggering who's the potential to breath spontaneously is hidden because of the ventilator management strategy by performing a simple 30sec-test with includes reducing the support from the ventilator. The findings will provide clear advice to doctors on how to better care for these patients.

This will be a pilot randomized clinical trial including 70 adult patients (aimed at equal number of men and woman) sedated and under controlled ventilation having reverse triggering. The study will be conducted in two ICUs: 1) St. Michael's Hospital, Toronto Canada and 2) Toronto Western Hospital, Toronto, Canada.

Conditions

Reverse Triggering

Patient Ventilator Dyssynchrony

Study ID

NCT06445049

Start date

Aug 25, 2025

Status verified date

Aug, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult patients (aimed at equal number of men and woman) sedated and under controlled ventilation having reverse triggering.

Exclusion Criteria:

  • under current use of continuous neuromuscular blocking agent or severe metabolic acidosis (Ph<7.25) at the time of study procedure.

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

no intervention: Standard Care

The participant will receive the current standard intensive care.

active comparator: brief test

The intervention is a simple brief test as follows: With the ventilator set with the patient clinical settings, it will be performed an up to 30sec-long or two inspiratory effort and-expiratory occlusion maneuver on the ventilator and/or switch the patient to pressure support for up to 30sec-long to assess the presence of intrinsic respiratory rate.

If an intrinsic respiratory rate ≥8 breaths per minute is present and P/F ratio is ≥150 it will be performed a 5-minute "test" in pressure support ventilation with the pressure support level to match the clinical setting of the patient. If the patient tolerates well 5 minutes in pressure support (see criteria below) the clinical team will be informed:

\- It will be indicated that the patient tolerated 5 min of PSV and suggest to the clinicians and physician in charge to transition the patient to pressure support ventilation plus suggest reducing sedation.

Interventions

brief test

The intervention is a simple brief test as follows: With the ventilator set with the patient clinical settings, it will be performed an up to 30sec-long or two inspiratory effort and-expiratory occlusion maneuver on the ventilator and/or switch the patient to pressure support for up to 30sec-long to assess the presence of intrinsic respiratory rate.

If an intrinsic respiratory rate ≥8 breaths per minute is present and P/F ratio is ≥150 it will be performed a 5-minute "test" in pressure support ventilation with the pressure support level to match the clinical setting of the patient. If the patient tolerates well 5 minutes in pressure support (see criteria below) the clinical team will be informed:

\- It will be indicated that the patient tolerated 5 min of PSV and suggest to the clinicians and physician in charge to transition the patient to pressure support ventilation plus suggest reducing sedation.

Primary outcome measure

  • Number of patients tolerating the transition to assisted breathing, or having an SBT, or being extubated within 48 hours [ Time Frame: 48 hours ]

Central Contacts and Locations

Central contacts

Laurent Brochard, MD

4168645686laurent.brochard@unityhealth.to

Antenor Rodrigues, Ph.D.

antenor.rodrigues@unityhealth.to

Locations

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B1W8

Contacts

Nattapat Wongtirawit, M.D.

416-864-6060nattapat.wongtirawit@unityhealth.to

More Information

Sponsor

Unity Health Toronto

Last update posted

Nov 10, 2026

Last verified

Aug, 2026

Keywords

  • Mechanical Ventilation
  • Dyssynchrony
  • Reverse Triggering
  • Intensive Care Unit

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-11. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2026-11-10. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.