Clinical trial NCT04000997: The Predictive Value of Peak Cough Flow for Endotracheal Extubation of Patients After Craniotomy
Official title: The Predictive Value of Cough Peak Flow for Extubation Success in Mechanically Ventilated Patients After Craniotomy: a Single-center Prospective Diagnostic Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Extubation Success
Craniofacial Pain Syndrome
Cough Peak Flow
Endotracheal Tube
Keywords: endotracheal tube
extubation success
cough peak flow
predictive value
post-craniotomy
critically ill
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2019-06-27
Enrollment: 785
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Predictive value of CPF for endotracheal extubation
timeFrame: 72h after extubation
Secondary outcomes:
measure: mortality rates
timeFrame: in hospital
Other outcomes:
Locations:
city: Beijing
country: China
facility: Jianfang Zhou
state: Beijing
Study officials:
affiliation: Beijing Tian Tan Hospital
name: Jianxin Zhou, MD
role: STUDY_DIRECTOR
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