NCT06627686

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 2, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 4, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2024

Completed
Last Updated

October 4, 2024

Status Verified

October 1, 2024

Enrollment Period

1 year

First QC Date

October 2, 2024

Last Update Submit

October 3, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

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

    One day

Study Arms (1)

Traumatic brain injury

Air way occlusion pressure and maximum inspiratory pressure

Diagnostic Test: Air way occlusion pressure

Interventions

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

Also known as: Maximal inspiratory pressure
Traumatic brain injury

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Traumatic brain injury (closed type) patients who will be admitted to ICU and intubated and MV more than 24 hours will be included in this study. Age from 18 to 65 years (male or female). Fulfillment of Criteria of readiness for weaning off MV : Resolution of the cause of respiratory insufficiency and MV. Stable hemodynamic profile

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Ali Rashad Ahmed

Tanta, Mahala, 13821, Egypt

RECRUITING

MeSH Terms

Interventions

Maximal Respiratory Pressures

Intervention Hierarchy (Ancestors)

Respiratory Function TestsDiagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Ali Rashad, MBBCH

    Benha University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali Rashad, MBBCH

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 2, 2024

First Posted

October 4, 2024

Study Start

September 1, 2023

Primary Completion

September 1, 2024

Study Completion

October 5, 2024

Last Updated

October 4, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations