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

NCT04000997 | Completed

• 1 other identifier: JZhou-1
• Study Type: observational
• Target: 785
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Predictive value of CPF for endotracheal extubation

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

  72h after extubation

Secondary Outcomes (1)

• mortality rates

  in hospital

Study Arms (2)

Failure group

Patients with a failure extubation

Success group

Patients with a successful extubation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Jianfang Zhou

Beijing, Beijing Municipality, 100020, China

Location

Related Publications (11)

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  PMID: 23857695 BACKGROUND

• 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.

  PMID: 27870576 BACKGROUND

• 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.

  PMID: 25441577 BACKGROUND

• 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.

  PMID: 24368359 BACKGROUND

• Bosel J, Schiller P, Hook Y, Andes M, Neumann JO, Poli S, Amiri H, Schonenberger 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.

  PMID: 23204058 BACKGROUND

• 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.

  PMID: 29223743 BACKGROUND

• 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.

  PMID: 26759420 BACKGROUND

• 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.

  PMID: 30336945 BACKGROUND

• 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.

  PMID: 27864615 BACKGROUND

• 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.

  PMID: 29359301 BACKGROUND

• Zhou J, Li HL, Luo XY, Chen GQ, Yang YL, Zhang L, Xu M, Shi GZ, Zhou JX. Predictive value of cough peak flow for successful extubation in mechanically ventilated patients after craniotomy: a single-centre prospective diagnostic study. BMJ Open. 2025 Jan 2;15(1):e088219. doi: 10.1136/bmjopen-2024-088219.

  PMID: 39753249 DERIVED

MeSH Terms

Conditions

Facial Neuralgia; Critical Illness

Condition Hierarchy (Ancestors)

Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jianxin Zhou, MD

  Beijing Tian Tan Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: June 27, 2019
• Study Start: August 1, 2019
• Primary Completion: February 28, 2021
• Study Completion: December 31, 2021
• Last Updated: October 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: June to December 2025
• Access Criteria: It is necessary to provide materials related to the purpose of the data and the usage plan, and sign a data sharing agreement. In addition, the use of the data is subject to the approval of the Ethics Committee of our hospital. The first author can be contacted by email.

Locations

CN (1)