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Clinical Trials/NCT06627686
NCT06627686RecruitingNot Applicable

Predictive Value of Airway Occlusion Pressure, Maximal Inspiratory Pressure and Their Ratio for Successful Extubation in Patients With Traumatic Brain Injury Observational Study

Benha University1 site in 1 country60 target enrollmentStarted: September 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
60
Locations
1
Primary Endpoint
Sensetivity, specifity, predictive values, and accuracy of Maximal inspiratory pressure, Airway occlusion pressure and their ratio will be determined by ROC curve.

Study Overview

Brief Summary

The aim of this study will be to measure the predictive power of the respiratory muscle determinants including The maximal inspiratory pressure, and central drive determinant including Airway occlusion pressure and ratio between them in weaning outcome of traumatic brain injury patients undergoing invasive mechanical ventilation.

Detailed Description

Before spontaneous breathing trials with a T-piece for 30 min with an FIO2 of 0.40, measurements will be performed for a 20-second period. Three parameters will be analyzed: PImax, P0.1, and P0.1/PImax. PImax and P0.1 will be obtained using a unidirectional valve method and a manovacuometer (Instrumentation Industries, Bethel Park, PA) attached to the airway.

The device will have a scale of 30 cm H2O with a 1 cm H2O interval, and will be designed to perform measurements at each 0.1 second. Prior to testing, all subjects will be on pressure support ventilation mode (12-20 cm H2O) and will not be on sedatives. The head of the subject's bed will be elevated to 45 degrees and the cuff of the artificial airway will be hyperinflated to prevent air leakage during measurement.

The subject will have the airway clear of secretions by suctioning with standard tracheal suction procedures after pre-oxygenation for 2 minutes with FIO2 of 1.0.

After a brief rest period, pre-oxygenation will be repeated. The subject will then be disconnected from mechanical ventilation and allowed to breathe spontaneously for 10 seconds before connecting the artificial airway to the manovacuometer when the subject will at functional residual capacity. The subject will continuously be monitored by pulse oximetry and electrocardiogram, and will have continual respiratory physiotherapist attention.

For the present study, respiratory drive (P0.1) will be calculated as an average of the measured inspiratory pressure 0.1 s after the initiation of the inspiration for the first 3 cycles, and P0.1/PImax as the ratio of absolute values of P0.1 and PImax. The subjects will not coached for the maneuver. Thresholds for the 3 parameters will be calculated from their respective receiver operating characteristic (ROC) curves. Values more negative than -25 cm H2Owere used to predict successful weaning.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Sensetivity, specifity, predictive values, and accuracy of Maximal inspiratory pressure, Airway occlusion pressure and their ratio will be determined by ROC curve.

Time Frame: One day

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ali Rashad Ahmed Abd El Bary

Principal investigator

Benha University

Study Sites (1)

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