The Predictive Value of Peak Cough Flow for Endotracheal Extubation of Patients After Craniotomy (PCFET)
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|ClinicalTrials.gov Identifier: NCT04000997|
Recruitment Status : Not yet recruiting
First Posted : June 27, 2019
Last Update Posted : June 27, 2019
|Condition or disease|
|Extubation Craniotomy Cough Endotracheal Tube|
The objection of this study is to evaluate the preditive value of PCF for endotracheal extubation in patients undergoing craniotomy. For patients who met the inclusion criteria, the PCF value will be measured before the removal of entracheal tubes, and the predictive value of PCF will be evaluated by ROC curves, as will as the cut-off value of PCF. Logistic regression stratified analysis will be used to adjust the influence of other risk factors of endotracheal extubation.
Two subgroup analysis will be carried out. According to state of consciousness, patients will be grouped as consciousness and unconsciousness group, and the predictive value of PCF for endotracheal extubation will be evaluated seprately in both groups. For patients with disturbance of consciousness, only passive PCF value will be measured. For lucid patients, inaddition to passive PCF value, the voluntary PCF value will also be measured.
According to anatomic site of lesion, patients will be divided into supratentorial and intracranial groups, and the predictive value of PCF for endotracheal extubation will be evaluated seprately in both groups.
|Study Type :||Observational|
|Estimated Enrollment :||301 participants|
|Official Title:||The Predictive Value of Peak Cough Flow for Endotracheal Extubation of Patients After Craniotomy-A Prospective Cohort Study|
|Estimated Study Start Date :||October 1, 2019|
|Estimated Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||December 31, 2021|
Patients with a failure endotracheal extubation
Patients with a successful endotracheal extubation
- Predictive value of PCF for endotracheal extubation [ Time Frame: 72h after extubation ]Failure of extubation refers to re-intubation within 72 hours after extubation or the need for non-invasive ventilation (NIV). Predictive value of PCF for endotracheal extubation of post-craniotomy patients
- mortality rates [ Time Frame: 28 days ]the differences of mortality rates between patients with a failure an successful extubation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04000997
|Contact: Jianfang Zhou, MDemail@example.com|
|Study Director:||Jianxin Zhou, MD||Beijing Tian Tan Hospital|