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

October 18, 2024 updated by: Jianfang Zhou, Beijing Tiantan Hospital

The Predictive Value of Cough Peak Flow for Extubation Success in Mechanically Ventilated Patients After Craniotomy: a Single-center Prospective Diagnostic Study

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

785

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100020
        • Jianfang Zhou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients admitted into ICU ward after craniotomy will be screened. Those ones meeting the including criteria will be included. patients would be grouped by their extubation outcomes.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Failure group
Patients with a failure extubation
Success group
Patients with a successful extubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictive value of CPF for endotracheal extubation
Time Frame: 72h after extubation
Failure of extubation refers to re-intubation within 72 hours after extubation
72h after extubation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mortality rates
Time Frame: in hospital
Comparison of mortality rates between patients with failed extubation and successful extubation.
in hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tiantan Hospital

Investigators

  • Study Director: Jianxin Zhou, MD, Beijing Tian tan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2019

Primary Completion (Actual)

February 28, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

June 26, 2019

First Submitted That Met QC Criteria

June 26, 2019

First Posted (Actual)

June 27, 2019

Study Record Updates

Last Update Posted (Actual)

October 21, 2024

Last Update Submitted That Met QC Criteria

October 18, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JZhou-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data sets generated during the current study are available from the first author on reasonable request.

IPD Sharing Time Frame

June to December 2025

IPD Sharing Access Criteria

It is necessary to provide materials related to the purpose of the data and the usage plan, and sign a data sharing agreement. In addition, the use of the data is subject to the approval of the Ethics Committee of our hospital. The first author can be contacted by email.

IPD Sharing Supporting Information Type

  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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