Clinical trial NCT06445049: Intrinsic Respiratory Rate Assessment During Mechanical Ventilation to Accelerate Spontaneous Breathing and Extubation
Official 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Reverse Triggering
Patient Ventilator Dyssynchrony
Keywords: Mechanical Ventilation
Dyssynchrony
Reverse Triggering
Intensive Care Unit
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2024-06-06
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Deferred consent model
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients tolerating the transition to assisted breathing, or having an SBT, or being extubated within 48 hours
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Unity Health Toronto - St. Michael's Hospital
name: Laurent Brochard
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rodrigues A, Telias I, Damiani LF, Brochard L. Reverse Triggering during Controlled Ventilation: From Physiology to Clinical Management. Am J Respir Crit Care Med. 2023 Mar 1;207(5):533-543. doi: 10.1164/rccm.202208-1477CI.