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Completed

NCT Number: NCT04000997

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Predictive value of CPF for endotracheal extubation

    Time frame: 72h after extubation

    Failure of extubation refers to re-intubation within 72 hours after extubation

Secondary outcomes

  1. mortality rates

    Time frame: in hospital

    Comparison of mortality rates between patients with failed extubation and successful extubation.

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

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

Acronym: PCFET

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 27, 2019
Registry last updated
Oct 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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