Delayed ExtubationNCT07658456
Factors Associated With Late Extubation in Postoperative Patients in the Surgical Intensive Care Unit
An observational study of Delayed Extubation and Postoperative Intensive Care, run by Kaohsiung Armed Forces General Hospital at 1 site in Taiwan.
Trial summary
Timely removal of a breathing tube after surgery is an important part of recovery for patients admitted to the intensive care unit (ICU). In some cases, patients may require longer use of mechanical ventilation, which can be associated with longer hospital stays and a higher risk of complications. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Delayed Extubation, Postoperative Intensive Care, Mechanical Ventilation Weaning
- How many people
- 204 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Apr 2019to 31 Dec 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population consists of adult postoperative patients admitted to the surgical intensive care unit who required invasive mechanical ventilation as part of routine postoperative care. This retrospective observational study analyzes existing clinical data collected during standard medical practice. No additional interventions, procedures, or changes to patient management were involved.
Who may be able to join
- Postoperative patients admitted to the surgical intensive care unit.
- Patients who required invasive mechanical ventilation after surgery.
- Patients with documented intubation and extubation events during the ICU stay.
- Patients with available routine clinical data, including demographic information, respiratory parameters, and laboratory results.
Who cannot join
- Patients without documented extubation information.
- Patients admitted to non-surgical intensive care units.
- Patients with incomplete or missing key clinical data required for analysis.
- Patients who did not receive invasive mechanical ventilation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Related Factors of Post Operation Patients With Late Extubation in Surgical Intensive Care Unit
Timely removal of a breathing tube after surgery is an important part of recovery for patients admitted to the intensive care unit (ICU). In some cases, patients may require longer use of mechanical ventilation, which can be associated with longer hospital stays and a higher risk of complications.
The purpose of this study is to examine clinical factors that may be associated with delayed removal of breathing tubes in postoperative ICU patients. This study will use information that has already been routinely collected during standard medical care, such as patient characteristics, breathing-related measurements, fluid balance, and laboratory test results.
This is a retrospective observational study and does not involve any additional treatments, procedures, or changes to routine clinical care. By analyzing these existing data, the study aims to improve understanding of factors related to extubation timing and support future efforts to enhance postoperative ICU care.
Read the detailed description
Delayed extubation after surgery is a common clinical challenge in postoperative intensive care unit (ICU) patients and is associated with increased risks of pulmonary complications, prolonged mechanical ventilation, and extended hospitalization. Determining optimal extubation timing remains complex because respiratory mechanics, metabolic status, neurologic recovery, and perioperative stress responses must align for successful ventilator liberation.
This study is a retrospective observational study designed to identify clinical factors associated with delayed extubation in postoperative ICU patients and to develop predictive models using routinely collected clinical data. The institutional cohort includes adult postoperative patients admitted to the surgical ICU at Kaohsiung Armed Forces General Hospital who required invasive mechanical ventilation. An external cohort derived from the MIMIC-IV database is used to support model development and cross-domain learning. No additional interventions, procedures, or changes to standard clinical care are involved.
Delayed extubation is defined as removal of the endotracheal tube more than 24 hours after initiation of mechanical ventilation, while early extubation is defined as extubation within 24 hours. Demographic characteristics, disease severity scores, respiratory parameters, perioperative laboratory data, and fluid balance variables routinely documented in medical records are included for analysis.
Statistical analyses include univariable and multivariable regression models to identify factors independently associated with delayed extubation and hospital length of stay. In addition, machine learning and deep learning approaches are applied to explore complex interactions among clinical variables and to improve prediction performance. Transfer learning techniques are used to enhance model generalizability by integrating information from external ICU datasets while adapting to local institutional data.
The primary objective of this study is to improve understanding of physiologic, metabolic, and respiratory determinants of delayed extubation in postoperative ICU patients. The findings may support more individualized ventilator weaning strategies, reduce prolonged mechanical ventilation, and improve postoperative ICU care. This study involves secondary analysis of existing clinical data and poses no additional risk to patients.
- Being tested
- No Intervention - Retrospective Observational Study
- Keywords
- Delayed extubation, Surgical intensive care unit, Mechanical ventilation, Weaning, Machine learning, Postoperative care, Rapid shallow breathing index, serum calcium, cumulative fluid balance, weaning predictors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention - Retrospective Observational StudyOther
No intervention was administered or assigned in this study. This is a retrospective observational study based on secondary analysis of existing clinical data collected during routine clinical care. No changes to patient management, treatment decisions, or standard care were made as part of this study.
| Study group | Role | What they receive |
|---|---|---|
| Early Extubation Group | This cohort includes postoperative intensive care unit patients who were extubated within 24 hours after initiation of invasive mechanical ventilation. No interventions were assigned as part of this study. Clinical data were analyzed retrospectively. Receives: Other: No Intervention - Retrospective Observational Study | |
| Delayed Extubation Group | This cohort includes postoperative intensive care unit patients who were extubated more than 24 hours after initiation of invasive mechanical ventilation. No interventions were assigned as part of this study. Clinical data were analyzed retrospectively. Receives: Other: No Intervention - Retrospective Observational Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delayed Extubation
Delayed extubation is defined as removal of the endotracheal tube more than 24 hours after initiation of invasive mechanical ventilation during postoperative intensive care unit admission.
Measured: Within 24 hours to 30 days after initiation of invasive mechanical ventilation
Secondary outcomes (2)
Hospital Length of Stay
Hospital length of stay is defined as the total number of days from hospital admission to hospital discharge.
Measured: From hospital admission through hospital discharge, up to 30 days
Duration of Mechanical Ventilation
Duration of mechanical ventilation is defined as the time from initiation of invasive mechanical ventilation to successful extubation.
Measured: From initiation of invasive mechanical ventilation to extubation, up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start1 Apr 2019
- Primary completion30 Nov 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delayed ExtubationStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Armed Forces General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07658456
- Sponsor's protocol ID
- KAFGHIRB 108-006
- Status last verified
- May 2026
- First submitted
- 20 Apr 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Individual data sharing
- No: Individual participant data will not be shared because this is a retrospective observational study based on institutional clinical records. Data access is restricted by institutional policies and ethical approvals, and no consent for data sharing outside the study team was obtained.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Related Factors of Post Operation Patients With Late Extubation in Surgical Intensive Care Unit
- ClinicalTrials.gov ID
- NCT07658456
- Acronym / sponsor ID
- KAFGHIRB 108-006
- Keywords
- Delayed extubation, Surgical intensive care unit, Mechanical ventilation, Weaning, Machine learning, Postoperative care, Rapid shallow breathing index, serum calcium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Kaohsiung Armed Forces General HospitalUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 22 Jun 2026 (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.
Timely removal of a breathing tube after surgery is an important part of recovery for patients admitted to the intensive care unit (ICU). In some cases, patients may require longer use of mechanical ventilation, which can be associated with longer hospital stays and a higher risk of complications.
The purpose of this study is to examine clinical factors that may be associated with delayed removal of breathing tubes in postoperative ICU patients. This study will use information that has already been routinely collected during standard medical care, such as patient characteristics, breathing-related measurements, fluid balance, and laboratory test results.
This is a retrospective observational study and does not involve any additional treatments, procedures, or changes to routine clinical care. By analyzing these existing data, the study aims to improve understanding of factors related to extubation timing and support future efforts to enhance postoperative ICU care.
Detailed description
Delayed extubation after surgery is a common clinical challenge in postoperative intensive care unit (ICU) patients and is associated with increased risks of pulmonary complications, prolonged mechanical ventilation, and extended hospitalization. Determining optimal extubation timing remains complex because respiratory mechanics, metabolic status, neurologic recovery, and perioperative stress responses must align for successful ventilator liberation.
This study is a retrospective observational study designed to identify clinical factors associated with delayed extubation in postoperative ICU patients and to develop predictive models using routinely collected clinical data. The institutional cohort includes adult postoperative patients admitted to the surgical ICU at Kaohsiung Armed Forces General Hospital who required invasive mechanical ventilation. An external cohort derived from the MIMIC-IV database is used to support model development and cross-domain learning. No additional interventions, procedures, or changes to standard clinical care are involved.
Delayed extubation is defined as removal of the endotracheal tube more than 24 hours after initiation of mechanical ventilation, while early extubation is defined as extubation within 24 hours. Demographic characteristics, disease severity scores, respiratory parameters, perioperative laboratory data, and fluid balance variables routinely documented in medical records are included for analysis.
Statistical analyses include univariable and multivariable regression models to identify factors independently associated with delayed extubation and hospital length of stay. In addition, machine learning and deep learning approaches are applied to explore complex interactions among clinical variables and to improve prediction performance. Transfer learning techniques are used to enhance model generalizability by integrating information from external ICU datasets while adapting to local institutional data.
The primary objective of this study is to improve understanding of physiologic, metabolic, and respiratory determinants of delayed extubation in postoperative ICU patients. The findings may support more individualized ventilator weaning strategies, reduce prolonged mechanical ventilation, and improve postoperative ICU care. This study involves secondary analysis of existing clinical data and poses no additional risk to patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Extubation Group | – | Other: No Intervention - Retrospective Observational StudyThis cohort includes postoperative intensive care unit patients who were extubated within 24 hours after initiation of invasive mechanical ventilation. No interventions were assigned as part of this study. Clinical data were analyzed retrospectively. |
| Delayed Extubation Group | – | Other: No Intervention - Retrospective Observational StudyThis cohort includes postoperative intensive care unit patients who were extubated more than 24 hours after initiation of invasive mechanical ventilation. No interventions were assigned as part of this study. Clinical data were analyzed retrospectively. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consists of adult postoperative patients admitted to the surgical intensive care unit who required invasive mechanical ventilation as part of routine postoperative care. This retrospective observational study analyzes existing clinical data collected during standard medical practice. No additional interventions, procedures, or changes to patient management were involved.
Key inclusion criteria (4 listed)
- Postoperative patients admitted to the surgical intensive care unit.
- Patients who required invasive mechanical ventilation after surgery.
- Patients with documented intubation and extubation events during the ICU stay.
- Patients with available routine clinical data, including demographic information, respiratory parameters, and laboratory results.
Key exclusion criteria (4 listed)
- Patients without documented extubation information.
- Patients admitted to non-surgical intensive care units.
- Patients with incomplete or missing key clinical data required for analysis.
- Patients who did not receive invasive mechanical ventilation.
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 |
|---|---|---|
| No Intervention - Retrospective Observational StudyNo intervention was administered or assigned in this study. This is a retrospective observational study based on secondary analysis of existing clinical data collected during routine clinical care. No changes to patient management, treatment decisions, or standard care were made as part of this study. | Other | Delayed Extubation Group, Early Extubation Group |
Primary outcome
Delayed Extubation
Time frame: Within 24 hours to 30 days after initiation of invasive mechanical ventilation
Delayed extubation is defined as removal of the endotracheal tube more than 24 hours after initiation of invasive mechanical ventilation during postoperative intensive care unit admission.
2 secondary outcomes
Hospital Length of Stay
Time frame: From hospital admission through hospital discharge, up to 30 days
Duration of Mechanical Ventilation
Time frame: From initiation of invasive mechanical ventilation to extubation, up to 30 days
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 22 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because this is a retrospective observational study based on institutional clinical records. Data access is restricted by institutional policies and ethical approvals, and no consent for data sharing outside the study team was obtained.
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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 Delayed Extubation and Postoperative Intensive Care, run by Kaohsiung Armed Forces General Hospital at 1 site in Taiwan.
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 4 inclusion and 4 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 22 Jun 2026. 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 Taiwan. 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?
Delayed Extubation (time frame: Within 24 hours to 30 days after initiation of invasive mechanical ventilation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2026.