NCT07038291

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2025

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2025

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 26, 2025

Completed
Last Updated

June 26, 2025

Status Verified

June 1, 2025

Enrollment Period

3 months

First QC Date

June 10, 2025

Last Update Submit

June 17, 2025

Conditions

Keywords

Extubation failureICUVentilator

Outcome Measures

Primary Outcomes (1)

  • 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.

    From January 2021 to August 2025

Study Arms (2)

Extubation Failure

Patient with extubation failure

Other: Not applicable- observational study

Successful Extubation

Patient with successful extubation

Other: Not applicable- observational study

Interventions

Observational study without intervention

Extubation FailureSuccessful Extubation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients were intubated in Kanigara ICU for more than 24 hours in January 2021 until August 2024

You may qualify if:

  • Patient age 18 years old or more were intubated in Kanigara ICU RSCM more than 24 hours

You may not qualify if:

  • Dead or needed tracheostomy before extubation, or reintubated for surgical procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RSUPN Dr. Cipto Mangunkusumo

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Related Publications (12)

  • 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.

    PMID: 25810614BACKGROUND
  • Xie 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.

    PMID: 31374585BACKGROUND
  • Hazarika 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.

    PMID: 36779148BACKGROUND
  • Mokhlesi 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.

    PMID: 18028561BACKGROUND
  • Godet 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.

    PMID: 27749290BACKGROUND
  • Coplin 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.

    PMID: 10806150BACKGROUND
  • Tanaka 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.

    PMID: 37777790BACKGROUND
  • Al-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.

    PMID: 38396437BACKGROUND
  • Andreu 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.

    PMID: 32979642BACKGROUND
  • Epstein SK. Decision to extubate. Intensive Care Med. 2002 May;28(5):535-46. doi: 10.1007/s00134-002-1268-8. Epub 2002 Apr 12.

    PMID: 12029399BACKGROUND
  • Arcanjo 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.

    PMID: 36995853BACKGROUND
  • Kulkarni 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.

    PMID: 19826583BACKGROUND

Related Links

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Anesthesiology and Intensive Care Study Program

Study Record Dates

First Submitted

June 10, 2025

First Posted

June 26, 2025

Study Start

March 1, 2025

Primary Completion

May 30, 2025

Study Completion

June 5, 2025

Last Updated

June 26, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations