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
| Registry | NCT06445049, acronym INTRINSIC |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, supportive care |
| Enrollment | 70 (Estimated) |
| Sponsor | Unity Health Toronto (Other) |
| Conditions | Reverse Triggering, Patient Ventilator Dyssynchrony |
| Interventions | brief test (Other) |
| Dates | start 2024-07-30 (estimated), primary completion 2027-06-30 (estimated), completion 2027-06-30 (estimated), first posted 2024-06-06, last updated 2024-06-06 |
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All trials for Reverse Triggering All trials for Patient Ventilator Dyssynchrony All trials of brief test
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Standard Care | No intervention | The participant will receive the current standard intensive care. | |
| brief test | Active comparator | Other: 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. |
Sex: All, ages: 18 Years to any
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.