Extubation FailureNCT07038291
Factors Associated With Extubation Failure in Kanigara ICU (Intensive Care Unit) RSUPN Dr. Cipto Mangunkusumo
An observational study of Extubation Failure and Ventilated Patients, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
Extubation is the final stage after patients undergo weaning procedure from mechanical ventilation in the ICU. Extubation failure followed by reintubation is associated with worse patient outcomes, including prolonged length of stay, increased risk of pulmonary infections, need for tracheostomy, higher healthcare… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extubation Failure, Ventilated Patients
- What is being tested?
- Not applicable- observational study
- How many people
- 156 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Mar 2025to 5 Jun 2025
- 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 were intubated in Kanigara ICU for more than 24 hours in January 2021 until August 2024
Who may be able to join
- Patient age 18 years old or more were intubated in Kanigara ICU RSCM more than 24 hours
Who cannot join
- Dead or needed tracheostomy before extubation, or reintubated for surgical procedure
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
RSUPN Dr. Cipto Mangunkusumo
Jakarta Pusat, DKI Jakarta, 10430
About this study
Extubation is the final stage after patients undergo weaning procedure from mechanical ventilation in the ICU. Extubation failure followed by reintubation is associated with worse patient outcomes, including prolonged length of stay, increased risk of pulmonary infections, need for tracheostomy, higher healthcare costs, and increased mortality. Careful evaluation of various risk factors for extubation failure must be considered, therefore the extubation readiness guideline or checklist is essential before making the decision to extubate. This study aimed to identify factors associated with extubation failure in Kanigara ICU patients. This was a case-control study using secondary data from medical records of ICU patients who underwent extubation between January 2021 until August 2024. Variables analyzed included Glasgow Coma Scale (GCS) score, Arterial Blood Gas (ABG) results, hemodynamics, ventilator settings, airway protection ability, fluid balance, and airway-related problems. Bivariate and multivariate using logistic regression analyses were conducted to identify factors associated with extubation failure.
- Conditions
- Extubation Failure, Ventilated Patients
- Being tested
- Not applicable- observational study
- Keywords
- Extubation failure, ICU, Ventilator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable- observational studyOther
Observational study without intervention
| Study group | Role | What they receive |
|---|---|---|
| Extubation Failure | Patient with extubation failure Receives: Other: Not applicable- observational study | |
| Successful Extubation | Patient with successful extubation Receives: Other: Not applicable- observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Factors Associated with Extubation Failure analyzed using logistic regression analysis
Factors assessed were GCS score, hemodynamics, fluid balance, BGA results, airway protection ability, and airway related problems. Data were taken from medical records.
Measured: From January 2021 to August 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start1 Mar 2025
- Primary completion30 May 2025
- Study completion5 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Extubation FailureStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adhrie Sugiarto, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07038291
- Sponsor's protocol ID
- IndonesiaUAnes1006
- Status last verified
- Jun 2025
- First submitted
- 10 Jun 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Venkategowda PM, Mahendrakar K, Rao SM, Mutkule DP, Shirodkar CG, Yogesh H. Laryngeal air column width ratio in predicting post extubation stridor. Indian J Crit Care Med. 2015 Mar;19(3):170-3. doi: 10.4103/0972-5229.152763.
PubMed 25810614Xie J, Cheng G, Zheng Z, Luo H, Ooi OC. To extubate or not to extubate: Risk factors for extubation failure and deterioration with further mechanical ventilation. J Card Surg. 2019 Oct;34(10):1004-1011. doi: 10.1111/jocs.14189. Epub 2019 Aug 2.
PubMed 31374585Hazarika A, Singla K, Patel G, Mahajan V, Kahlon S, Meena S. Does Arterial Blood Gas (ABG) Provide a Safety Net for Extubation in Surgical Patients? Cureus. 2023 Jan 9;15(1):e33561. doi: 10.7759/cureus.33561. eCollection 2023 Jan.
PubMed 36779148Mokhlesi B, Tulaimat A, Gluckman TJ, Wang Y, Evans AT, Corbridge TC. Predicting extubation failure after successful completion of a spontaneous breathing trial. Respir Care. 2007 Dec;52(12):1710-7.
PubMed 18028561Godet T, Chabanne R, Marin J, Kauffmann S, Futier E, Pereira B, Constantin JM. Extubation Failure in Brain-injured Patients: Risk Factors and Development of a Prediction Score in a Preliminary Prospective Cohort Study. Anesthesiology. 2017 Jan;126(1):104-114. doi: 10.1097/ALN.0000000000001379.
PubMed 27749290Coplin WM, Pierson DJ, Cooley KD, Newell DW, Rubenfeld GD. Implications of extubation delay in brain-injured patients meeting standard weaning criteria. Am J Respir Crit Care Med. 2000 May;161(5):1530-6. doi: 10.1164/ajrccm.161.5.9905102.
PubMed 10806150Tanaka A, Shimomura Y, Uchiyama A, Tokuhira N, Kitamura T, Iwata H, Hashimoto H, Ishigaki S, Enokidani Y, Yamashita T, Koyama Y, Iguchi N, Yoshida T, Fujino Y. Time definition of reintubation most relevant to patient outcomes in critically ill patients: a multicenter cohort study. Crit Care. 2023 Sep 30;27(1):378. doi: 10.1186/s13054-023-04668-3.
PubMed 37777790Al-Husinat L, Jouryyeh B, Rawashdeh A, Robba C, Silva PL, Rocco PRM, Battaglini D. The Role of Ultrasonography in the Process of Weaning from Mechanical Ventilation in Critically Ill Patients. Diagnostics (Basel). 2024 Feb 12;14(4):398. doi: 10.3390/diagnostics14040398.
PubMed 38396437Andreu MF, Bezzi MG, Dotta ME. Incidence of immediate postextubation complications in critically Ill adult patients. Heart Lung. 2020 Nov-Dec;49(6):774-778. doi: 10.1016/j.hrtlng.2020.09.016. Epub 2020 Sep 24.
PubMed 32979642Epstein SK. Decision to extubate. Intensive Care Med. 2002 May;28(5):535-46. doi: 10.1007/s00134-002-1268-8. Epub 2002 Apr 12.
PubMed 12029399Arcanjo ABB, Beccaria LM. Factors associated with extubation failure in an intensive care unit: a case-control study. Rev Lat Am Enfermagem. 2023;31:e3864. doi: 10.1590/1518-8345.6224.3864.
PubMed 36995853Kulkarni AP, Agarwal V. Extubation failure in intensive care unit: predictors and management. Indian J Crit Care Med. 2008 Jan;12(1):1-9. doi: 10.4103/0972-5229.40942.
PubMed 19826583
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Extubation Failure in Kanigara ICU (Intensive Care Unit) RSUPN Dr. Cipto Mangunkusumo
- ClinicalTrials.gov ID
- NCT07038291
- Acronym / sponsor ID
- IndonesiaUAnes1006
- Conditions
- Extubation Failure, Ventilated Patients
- Keywords
- Extubation failure, ICU, Ventilator
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 5 Jun 2025 (actual)
- First posted
- 26 Jun 2025 (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.
Extubation is the final stage after patients undergo weaning procedure from mechanical ventilation in the ICU. Extubation failure followed by reintubation is associated with worse patient outcomes, including prolonged length of stay, increased risk of pulmonary infections, need for tracheostomy, higher healthcare costs, and increased mortality. Careful evaluation of various risk factors for extubation failure must be considered, therefore the extubation readiness guideline or checklist is essential before making the decision to extubate. This study aimed to identify factors associated with extubation failure in Kanigara ICU patients. This was a case-control study using secondary data from medical records of ICU patients who underwent extubation between January 2021 until August 2024. Variables analyzed included Glasgow Coma Scale (GCS) score, Arterial Blood Gas (ABG) results, hemodynamics, ventilator settings, airway protection ability, fluid balance, and airway-related problems. Bivariate and multivariate using logistic regression analyses were conducted to identify factors associated with extubation failure.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extubation Failure | – | Other: Not applicable- observational studyPatient with extubation failure |
| Successful Extubation | – | Other: Not applicable- observational studyPatient with successful extubation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were intubated in Kanigara ICU for more than 24 hours in January 2021 until August 2024
Key inclusion criteria (1 listed)
- Patient age 18 years old or more were intubated in Kanigara ICU RSCM more than 24 hours
Key exclusion criteria (1 listed)
- Dead or needed tracheostomy before extubation, or reintubated for surgical procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not applicable- observational studyObservational study without intervention | Other | Extubation Failure, Successful Extubation |
Primary outcome
Factors Associated with Extubation Failure analyzed using logistic regression analysis
Time frame: From January 2021 to August 2025
Factors assessed were GCS score, hemodynamics, fluid balance, BGA results, airway protection ability, and airway related problems. Data were taken from medical records.
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 26 Jun 2025.
- Background: PubMed 25810614Venkategowda PM, Mahendrakar K, Rao SM, Mutkule DP, Shirodkar CG, Yogesh H. Laryngeal air column width ratio in predicting post extubation stridor. Indian J Crit Care Med. 2015 Mar;19(3):170-3. doi: 10.4103/0972-5229.152763.
- Background: PubMed 31374585Xie J, Cheng G, Zheng Z, Luo H, Ooi OC. To extubate or not to extubate: Risk factors for extubation failure and deterioration with further mechanical ventilation. J Card Surg. 2019 Oct;34(10):1004-1011. doi: 10.1111/jocs.14189. Epub 2019 Aug 2.
- Background: PubMed 36779148Hazarika A, Singla K, Patel G, Mahajan V, Kahlon S, Meena S. Does Arterial Blood Gas (ABG) Provide a Safety Net for Extubation in Surgical Patients? Cureus. 2023 Jan 9;15(1):e33561. doi: 10.7759/cureus.33561. eCollection 2023 Jan.
- Background: PubMed 18028561Mokhlesi B, Tulaimat A, Gluckman TJ, Wang Y, Evans AT, Corbridge TC. Predicting extubation failure after successful completion of a spontaneous breathing trial. Respir Care. 2007 Dec;52(12):1710-7.
- Background: PubMed 27749290Godet T, Chabanne R, Marin J, Kauffmann S, Futier E, Pereira B, Constantin JM. Extubation Failure in Brain-injured Patients: Risk Factors and Development of a Prediction Score in a Preliminary Prospective Cohort Study. Anesthesiology. 2017 Jan;126(1):104-114. doi: 10.1097/ALN.0000000000001379.
- Background: PubMed 10806150Coplin WM, Pierson DJ, Cooley KD, Newell DW, Rubenfeld GD. Implications of extubation delay in brain-injured patients meeting standard weaning criteria. Am J Respir Crit Care Med. 2000 May;161(5):1530-6. doi: 10.1164/ajrccm.161.5.9905102.
- Background: PubMed 37777790Tanaka A, Shimomura Y, Uchiyama A, Tokuhira N, Kitamura T, Iwata H, Hashimoto H, Ishigaki S, Enokidani Y, Yamashita T, Koyama Y, Iguchi N, Yoshida T, Fujino Y. Time definition of reintubation most relevant to patient outcomes in critically ill patients: a multicenter cohort study. Crit Care. 2023 Sep 30;27(1):378. doi: 10.1186/s13054-023-04668-3.
- Background: PubMed 38396437Al-Husinat L, Jouryyeh B, Rawashdeh A, Robba C, Silva PL, Rocco PRM, Battaglini D. The Role of Ultrasonography in the Process of Weaning from Mechanical Ventilation in Critically Ill Patients. Diagnostics (Basel). 2024 Feb 12;14(4):398. doi: 10.3390/diagnostics14040398.
- Background: PubMed 32979642Andreu MF, Bezzi MG, Dotta ME. Incidence of immediate postextubation complications in critically Ill adult patients. Heart Lung. 2020 Nov-Dec;49(6):774-778. doi: 10.1016/j.hrtlng.2020.09.016. Epub 2020 Sep 24.
- Background: PubMed 12029399Epstein SK. Decision to extubate. Intensive Care Med. 2002 May;28(5):535-46. doi: 10.1007/s00134-002-1268-8. Epub 2002 Apr 12.
- Background: PubMed 36995853Arcanjo ABB, Beccaria LM. Factors associated with extubation failure in an intensive care unit: a case-control study. Rev Lat Am Enfermagem. 2023;31:e3864. doi: 10.1590/1518-8345.6224.3864.
- Background: PubMed 19826583Kulkarni AP, Agarwal V. Extubation failure in intensive care unit: predictors and management. Indian J Crit Care Med. 2008 Jan;12(1):1-9. doi: 10.4103/0972-5229.40942.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Failure and Ventilated Patients, run by Universitas Indonesia at 1 site in Indonesia.
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 1 inclusion and 1 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 26 Jun 2025. 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 Indonesia. 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?
Factors Associated with Extubation Failure analyzed using logistic regression analysis (time frame: From January 2021 to August 2025). 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 NCT07038291, which also lists 12 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 26 Jun 2025; AzTrials last refreshed its copy on 7 Nov 2026.