Actively Recruiting
Predictive Value of Airway Occlusion Pressure, Maximal Inspiratory Pressure and Their Ratio for Successful Extubation in Patients With Traumatic Brain Injury Observational Study
Led by Benha University · Updated on 2024-10-04
60
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
B
Benha University
Lead Sponsor
T
Tanta University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the ability of certain respiratory muscle and central drive measurements to predict successful removal from mechanical ventilation in patients with traumatic brain injury. The focus is on maximal inspiratory pressure (PImax), airway occlusion pressure (P0.1), and their ratio, to see how well these values forecast breathing success after extubation. This observational study involves patients who have been intubated and on mechanical ventilation for more than 24 hours in an intensive care setting. Measurements will be taken before spontaneous breathing trials, including a 20-second assessment of PImax, P0.1, and their ratio using specialized devices attached to the airway. Patients will be monitored closely during these tests to ensure safety, with specific criteria to stop the trial if signs of distress appear. If patients pass the breathing trial without deterioration, they will be extubated and receive oxygen support through a Venturi mask. Participants will be monitored continuously during the study with pulse oximetry and electrocardiogram and attended by respiratory physiotherapists. The main outcome measured is the accuracy of the respiratory parameters in predicting successful weaning from mechanical ventilation, defined as sustaining spontaneous breathing for 48 hours post-extubation. The study period includes measurements during breathing trials and follow-up for at least 48 hours after ventilator withdrawal.
CONDITIONS
Brief Title
Predictive Value of Airway Occlusion Pressure, Maximal Inspiratory Pressure and Their Ratio for Successful Extubation in Patients With Traumatic Brain Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Traumatic brain injury (closed type) patients who will be admitted to ICU and intubated and on mechanical ventilation for more than 24 hours
- Age from 18 to 65 years (male or female)
- Fulfillment of criteria of readiness for weaning off mechanical ventilation
- Resolution of the cause of respiratory insufficiency and mechanical ventilation
- Stable hemodynamic profile
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants have airway occlusion pressure and maximal inspiratory pressure measured before spontaneous breathing trials to assess readiness for extubation.
1 visit (in-person)
Duration - Up to 48 hours
Participants undergo spontaneous breathing trials and are continuously monitored for respiratory and hemodynamic stability to determine successful weaning from mechanical ventilation.
Continuous monitoring during the spontaneous breathing trial and extubation period
Trial Site Locations
Total: 1 location
1
Ali Rashad Ahmed
Tanta, Mahala, Egypt, 13821
Actively Recruiting
Research Team
A
Ali Rashad, MBBCH
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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