Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06445049
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-30
Brief Title:
Intrinsic Respiratory Rate Assessment During Mechanical Ventilation to Accelerate Spontaneous Breathing and Extubation
Sponsor:
Unity Health Toronto
Organization:
Unity Health Toronto
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INTRINSIC
Brief Summary:
The goal of this study is to identify patients with reverse triggering whos 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 Michaels Hospital Toronto Canada and 2 Toronto Western Hospital Toronto Canada
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 Michaels 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 Ph725 at the time of study procedure
Patients will be screened every morning from 800 am to 900 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 andor 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 PF 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
Patients will be excluded if under current use of continuous neuromuscular blocking agent or severe metabolic acidosis Ph725 at the time of study procedure
Patients will be screened every morning from 800 am to 900 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 andor 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 PF 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None