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Trial record 35 of 33639 for:    value

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

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ClinicalTrials.gov Identifier: NCT04000997
Recruitment Status : Not yet recruiting
First Posted : June 27, 2019
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
Jianfang Zhou, Beijing Tiantan Hospital

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
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.


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Study Type : Observational
Estimated Enrollment : 301 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
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

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



Primary Outcome Measures :
  1. Predictive value of PCF for endotracheal extubation [ Time Frame: 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 :
  1. mortality rates [ Time Frame: 28 days ]
    the differences of mortality rates between patients with a failure an successful extubation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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. For patients whose extubation is failed, the patients will be grouped as failure group. Whereas, if the extubation is successful, the patients will be grouped as seccess group.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04000997


Contacts
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Contact: Jianfang Zhou, MD 8610-59978451 zjfyanger@sina.com

Sponsors and Collaborators
Beijing Tiantan Hospital
Investigators
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Study Director: Jianxin Zhou, MD Beijing Tian Tan Hospital

Publications of Results:

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Responsible Party: Jianfang Zhou, MD, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT04000997     History of Changes
Other Study ID Numbers: JZhou-1
First Posted: June 27, 2019    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jianfang Zhou, Beijing Tiantan Hospital:
endotracheal tube
extubation
peak cough flow
predictive value
Additional relevant MeSH terms:
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Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms