Intrinsic Respiratory Rate Assessment During Mechanical Ventilation to Accelerate Spontaneous Breathing and Extubation
Reverse Triggering · Patient Ventilator Dyssynchrony
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 70 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Read the full description
The objective of this study is to investigate the impact of assessing intrinsic respiratory rate in mechanically ventilated patients with reverse triggering on the facilitation of transition to spontaneous breathing and successful extubation.
Patients will be excluded if under current use of continuous neuromuscular blocking agent or severe metabolic acidosis (Ph\<7.25 at the time of study procedure.
Patients will be screened every morning from 8:00 am to 9:00 am all the patients under controlled ventilation to detect the presence of reverse triggering by looking at the screen on the ventilator (2-5 min observation). The research team (research MDs, physiotherapists and respiratory therapists) is very well trained at detecting reverse triggering. Patients will then be randomized to standard of care or intervention using a deferred consent model.
- Control group: standard care.
- Intervention group: 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 pressure support ventilation and suggest to the clinicians and physician in charge to transition the patient to pressure support ventilation plus suggest reducing sedation.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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.
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- No masking
Standard Care
The participant will receive the current standard intensive care.
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.
Other: brief test
brief test OTHER
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.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Number of patients tolerating the transition to assisted breathing, or having an SBT, or being extubated within 48 hours
Time frame: 48 hours
Number of patients tolerating the transition to assisted breathing (e.g., Pressure Support Ventilation, Neurally Adjusted Ventilatory Assist, Proportional assist ventilation with load-adjustable gain factors), or having an SBT, or being extubated within 48 hours
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (2)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
2 locations
St. Michael's HospitalToronto, Ontario, CanadaRecruiting
Toronto Western HospitalToronto, Ontario, CanadaNot yet recruiting
Study team and timeline
- Lead sponsor
- Unity Health Toronto
- Study start
- Aug 25, 2025 Actual
- Primary completion
- Jun 30, 2027 Estimated
- Study completion
- Jun 30, 2027 Estimated
- First posted
- Jun 6, 2024 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
Assessing Intrinsic Respiratory Rate in Mechanically Ventilated Adult Patients With Reverse Triggering as an Incentive for Accelerating Transition to Spontaneous Breathing and Extubation: Pilot Randomized Clinical Trial - INTRINSIC
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026