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出境医 / 临床实验 / The Predictive Value of Peak Cough Flow for Endotracheal Extubation of Patients After Craniotomy (PCFET)

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

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
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
Layout table for study information
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
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
Group/Cohort
Failure group
Patients with a failure endotracheal extubation
Success group
Patients with a successful endotracheal extubation
Outcome Measures
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


Eligibility Criteria
Layout table for eligibility information
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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Jianfang Zhou, MD 8610-59978451 zjfyanger@sina.com

Locations
Layout table for location information
China, Beijing
Jianfang Zhou Recruiting
Beijing, Beijing, China, 100020
Contact: Jianfang Zhou, MD    8613241078866 ext 861059978451    zjfyanger@sina.com   
Sponsors and Collaborators
Beijing Tiantan Hospital
Investigators
Layout table for investigator information
Study Director: Jianxin Zhou, MD Beijing Tian Tan Hospital
Tracking Information
First Submitted Date June 26, 2019
First Posted Date June 27, 2019
Last Update Posted Date February 20, 2020
Actual Study Start Date February 1, 2019
Estimated Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 26, 2019) 		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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 26, 2019) 		mortality rates [ Time Frame: 28 days ]
the differences of mortality rates between patients with a failure an successful extubation
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Predictive Value of Peak Cough Flow for Endotracheal Extubation of Patients After Craniotomy
Official Title The Predictive Value of Peak Cough Flow for Endotracheal Extubation of Patients After Craniotomy-A Prospective Cohort Study
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. 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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Extubation
  • Craniotomy
  • Cough
  • Endotracheal Tube
Intervention Not Provided
Study Groups/Cohorts
  • Failure group
    Patients with a failure endotracheal extubation
  • Success group
    Patients with a successful endotracheal extubation
Publications *
  • Reis HF, Almeida ML, Silva MF, Rocha Mde S. Extubation failure influences clinical and functional outcomes in patients with traumatic brain injury. J Bras Pneumol. 2013 May-Jun;39(3):330-8. doi: 10.1590/S1806-37132013000300010. English, Portuguese.
  • McCredie VA, Ferguson ND, Pinto RL, Adhikari NK, Fowler RA, Chapman MG, Burrell A, Baker AJ, Cook DJ, Meade MO, Scales DC; Canadian Critical Care Trials Group. Airway Management Strategies for Brain-injured Patients Meeting Standard Criteria to Consider Extubation. A Prospective Cohort Study. Ann Am Thorac Soc. 2017 Jan;14(1):85-93. doi: 10.1513/AnnalsATS.201608-620OC.
  • Hyde GA, Savage SA, Zarzaur BL, Hart-Hyde JE, Schaefer CB, Croce MA, Fabian TC. Early tracheostomy in trauma patients saves time and money. Injury. 2015 Jan;46(1):110-4. doi: 10.1016/j.injury.2014.08.049. Epub 2014 Sep 16.
  • Alali AS, Scales DC, Fowler RA, Mainprize TG, Ray JG, Kiss A, de Mestral C, Nathens AB. Tracheostomy timing in traumatic brain injury: a propensity-matched cohort study. J Trauma Acute Care Surg. 2014 Jan;76(1):70-6; discussion 76-8. doi: 10.1097/TA.0b013e3182a8fd6a.
  • Bösel J, Schiller P, Hook Y, Andes M, Neumann JO, Poli S, Amiri H, Schönenberger S, Peng Z, Unterberg A, Hacke W, Steiner T. Stroke-related Early Tracheostomy versus Prolonged Orotracheal Intubation in Neurocritical Care Trial (SETPOINT): a randomized pilot trial. Stroke. 2013 Jan;44(1):21-8. doi: 10.1161/STROKEAHA.112.669895. Epub 2012 Nov 29.
  • Herritt B, Chaudhuri D, Thavorn K, Kubelik D, Kyeremanteng K. Early vs. late tracheostomy in intensive care settings: Impact on ICU and hospital costs. J Crit Care. 2018 Apr;44:285-288. doi: 10.1016/j.jcrc.2017.11.037. Epub 2017 Dec 22.
  • Kaese S, Zander MC, Lebiedz P. Successful Use of Early Percutaneous Dilatational Tracheotomy and the No Sedation Concept in Respiratory Failure in Critically Ill Obese Subjects. Respir Care. 2016 May;61(5):615-20. doi: 10.4187/respcare.04333. Epub 2016 Jan 12.
  • Wang R, Pan C, Wang X, Xu F, Jiang S, Li M. The impact of tracheotomy timing in critically ill patients undergoing mechanical ventilation: A meta-analysis of randomized controlled clinical trials with trial sequential analysis. Heart Lung. 2019 Jan;48(1):46-54. doi: 10.1016/j.hrtlng.2018.09.005. Epub 2018 Oct 15. Review.
  • Tipping CJ, Harrold M, Holland A, Romero L, Nisbet T, Hodgson CL. The effects of active mobilisation and rehabilitation in ICU on mortality and function: a systematic review. Intensive Care Med. 2017 Feb;43(2):171-183. doi: 10.1007/s00134-016-4612-0. Epub 2016 Nov 18. Review.
  • Pisegna JM, Murray J. Clinical Application of Flexible Endoscopic Evaluation of Swallowing in Stroke. Semin Speech Lang. 2018 Feb;39(1):3-14. doi: 10.1055/s-0037-1608855. Epub 2018 Jan 22. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 26, 2019) 		301
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2021
Estimated Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Jianfang Zhou, MD 8610-59978451 zjfyanger@sina.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04000997
Other Study ID Numbers JZhou-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Jianfang Zhou, Beijing Tiantan Hospital
Study Sponsor Beijing Tiantan Hospital
Collaborators Not Provided
Investigators
Study Director: Jianxin Zhou, MD Beijing Tian Tan Hospital
PRS Account Beijing Tiantan Hospital
Verification Date February 2020

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