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

Endotracheal Tube Clinical Trial

— PCFET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04000997
• Other study ID #: JZhou-1
• Status: Completed
• Start date: August 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2024
• Source: Beijing Tiantan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 785
• Est. completion date: December 31, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cough
• Endotracheal Tube
• Facial Neuralgia
• Facial Pain

Locations

Country	Name	City	State
China	Jianfang Zhou	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

References & Publications (10)

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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 pil — View Citation

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. — View Citation

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. — View Citation

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 Ja — View Citation

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 E — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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): — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predictive value of CPF for endotracheal extubation	Failure of extubation refers to re-intubation within 72 hours after extubation	72h after extubation
Secondary	mortality rates	Comparison of mortality rates between patients with failed extubation and successful extubation.	in hospital