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

Sponsor

Beijing Tiantan Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04000997

Collaborator

(none)

300

Enrollment

Location

Actual Duration (Months)

13.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Extubation Craniotomy Cough Endotracheal Tube

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. 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 Design

Study Type:

Observational

Actual Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

The Predictive Value of Peak Cough Flow for Endotracheal Extubation of Patients After Craniotomy-A Prospective Cohort Study

Actual Study Start Date :

Feb 1, 2019

Actual Primary Completion Date :

Feb 28, 2020

Actual Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Failure group Patients with a failure endotracheal extubation
Success group Patients with a successful endotracheal extubation

Outcome Measures

Primary Outcome Measures

Predictive value of PCF for endotracheal extubation [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

Secondary Outcome Measures

mortality rates [28 days]
the differences of mortality rates between patients with a failure an successful extubation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Previous chronic cardiac insufficiency (NYHA grade 4)
Previous chronic respiratory insufficiency (APACHE II chronic health score)
After tracheotomy
History of upper airway injury, deformity or leisions
Pregnant or lactating women
Participation in other clinical trials
Patients or immediate family members refuse to sign the informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jianfang Zhou	Beijing	Beijing	China	100020

Sponsors and Collaborators

Beijing Tiantan Hospital

Investigators

Study Director: Jianxin Zhou, MD, Beijing Tian Tan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jianfang Zhou, MD, Beijing Tiantan Hospital

ClinicalTrials.gov Identifier:

NCT04000997

Other Study ID Numbers:

JZhou-1

First Posted:

Jun 27, 2019

Last Update Posted:

Aug 5, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jianfang Zhou, MD, Beijing Tiantan Hospital

Additional relevant MeSH terms:

Cough

Study Results

No Results Posted as of Aug 5, 2021