Extubation SuccessPCFETNCT04000997
The Predictive Value of Peak Cough Flow for Endotracheal Extubation of Patients After Craniotomy
An observational study of Extubation Success and Craniofacial Pain Syndrome, run by Beijing Tiantan Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extubation Success, Craniofacial Pain Syndrome, Cough Peak Flow
- How many people
- 785 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2019to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age ≥ 18 years
- Post- craniotomy
- ICU LOS ≥ 24h
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Predictive Value of Cough Peak Flow for Extubation Success in Mechanically Ventilated Patients After Craniotomy: a Single-center Prospective Diagnostic Study
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.
Read the 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.
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.
- Keywords
- endotracheal tube, extubation success, cough peak flow, predictive value, post-craniotomy, critically ill
- Medical subject headings
- Facial Neuralgia, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Failure group | Patients with a failure extubation | |
| Success group | Patients with a successful extubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive value of CPF for endotracheal extubation
Failure of extubation refers to re-intubation within 72 hours after extubation
Measured: 72h after extubation
Secondary outcomes (1)
mortality rates
Comparison of mortality rates between patients with failed extubation and successful extubation.
Measured: in hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start1 Aug 2019
- Primary completion28 Feb 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Extubation SuccessStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 785 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianfang Zhou, Beijing Tiantan Hospital
- Investigators
- Jianxin Zhou, MD, Study director, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04000997
- Sponsor's protocol ID
- JZhou-1
- Acronym
- PCFET
- Status last verified
- Feb 2024
- First submitted
- 26 Jun 2019
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sets generated during the current study are available from the first author on reasonable request.
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.
PubMed 23857695McCredie 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.
PubMed 27870576Hyde 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.
PubMed 25441577Alali 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.
PubMed 24368359Bosel 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.
PubMed 23204058Herritt 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.
PubMed 29223743Kaese 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.
PubMed 26759420Wang 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.
PubMed 30336945Tipping 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.
PubMed 27864615Pisegna 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.
PubMed 29359301Zhou 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.
PubMed 39753249
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive Value of Cough Peak Flow for Extubation Success in Mechanically Ventilated Patients After Craniotomy: a Single-center Prospective Diagnostic Study
- ClinicalTrials.gov ID
- NCT04000997
- Acronym / sponsor ID
- PCFET / JZhou-1
- Keywords
- endotracheal tube, extubation success, cough peak flow, predictive value, post-craniotomy, critically ill
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 785 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 27 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Failure group | – | –Patients with a failure extubation |
| Success group | – | –Patients with a successful extubation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Post- craniotomy
- ICU LOS ≥ 24h
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Predictive value of CPF for endotracheal extubation
Time frame: 72h after extubation
Failure of extubation refers to re-intubation within 72 hours after extubation
1 secondary outcome
mortality rates
Time frame: in hospital
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- Results publication: PubMed 23857695Reis 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.
- Results publication: PubMed 27870576McCredie 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.
- Results publication: PubMed 25441577Hyde 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.
- Results publication: PubMed 24368359Alali 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.
- Results publication: PubMed 23204058Bosel 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.
- Results publication: PubMed 29223743Herritt 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.
- Results publication: PubMed 26759420Kaese 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.
- Results publication: PubMed 30336945Wang 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.
- Results publication: PubMed 27864615Tipping 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.
- Results publication: PubMed 29359301Pisegna 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.
- Derived from this study: PubMed 39753249Zhou 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.
- Individual participant dataSharing planned: Yes. Data sets generated during the current study are available from the first author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianxin Zhou, MD study director
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Extubation Success and Craniofacial Pain Syndrome, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive value of CPF for endotracheal extubation (time frame: 72h after extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04000997, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2024.