Actively Recruiting

Age: 18Years - 65Years
All Genders
Healthy Volunteers
ID06627686

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

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

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)

Monitoring

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

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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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