The Predictive Value of Peak Cough Flow for Endotracheal Extubation of Patients After Craniotomy

NCT ID: NCT04000997

Last Updated: 2024-10-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 785 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2021-12-31

Brief Summary

In severe cases after craniotomy, tracheal intubation is often required, and the removal of tracheal intubation presents certain risks and challenges. Premature removal of the tracheal intubation can lead to failure of extubation and increased proportion of re-intubation, resulting in increased risk of airway injury and hospital-acquired pneumonia, resulting in prolonged hospital stay and even adverse effects on neurological outcomes and mortality. However, delayed extubation can also lead to an increased risk of hospital acquired pneumonia, affecting early recovery and neurological recovery. It can be seen that the accurate evaluation of the possibility of tracheal intubation and the appropriate timing can have a greater impact on the prognosis of patients after craniotomy. However, there are currently no relevant standards or guidelines to guide clinical work. Previous studies have shown that for general critically ill patients, Peak cough flow (PCF) can play a certain role in predicting tracheal intubation, but the results of each study are not consistent. The predictive value of PCF for tracheal intubation and extubation in patients after craniotomy is less relevant. This study intends to use Pneumotachograph to measure the active and passive PCF of patients with extubation, to explore the predictive value of PCF for tracheal intubation after craniotomy, and to provide guidance for the development of clinical extubation decisions.

Detailed Description

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.

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.

Conditions

Extubation Success; Craniofacial Pain Syndrome; Cough Peak Flow; Endotracheal Tube

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Failure group

Patients with a failure extubation

No interventions assigned to this group

Success group

Patients with a successful extubation

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years
• Post- craniotomy
• ICU LOS ≥ 24h

Exclusion Criteria

• no extubation attempt during the ICU stay;
• underwent tracheostomy without extubation attempt;
• pregnant or lactating women;
• enrolled in other clinical trials;
• declined to participate in the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jianfang Zhou

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jianxin Zhou, MD

Role: STUDY_DIRECTOR

Beijing Tian Tan Hospital

Locations

Jianfang Zhou

Beijing, Beijing Municipality, China

Countries

China

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Other Identifiers

JZhou-1

Identifier Type: -

Identifier Source: org_study_id