Postoperative Respiratory FailureNCT07672106
Assessment of Reintubation Risk Using Multiple Parameters in Postoperative Intensive Care Unit Patients
An observational study of Postoperative Respiratory Failure and Extubation Failure, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
Trial summary
This prospective, non-interventional observational study will evaluate the risk of reintubation in adult postoperative patients admitted to the intensive care unit after major surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Respiratory Failure, Extubation Failure, Lung Ultrasonography Score
- How many people
- 600 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Apr 2026to 28 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adult postoperative patients aged 18 years and older who are admitted to the anesthesia and reanimation intensive care units after major surgery, including abdominal, vascular, orthopedic, and ear, nose, throat, head and neck surgery. Eligible patients will be those extubated in the operating room and admitted to the intensive care unit with spontaneous breathing during the study period after ethics committee approval.
Who may be able to join
- Adult patients aged 18 years and older
- Patients requiring postoperative intensive care follow-up after major surgery, including abdominal, vascular, orthopedic, or ear, nose, throat, head and neck surgery
- Patients extubated in the operating room and admitted to the intensive care unit with spontaneous breathing
- Patients without any clinical condition preventing the planned measurements within the first 0-2 hours after ICU admission (T0 and T1)
- Patients for whom written informed consent can be obtained from the patient or legally authorized representative
- Patients admitted to the intensive care unit within the specified study period after ethics committee approval and enrolled consecutively
Who cannot join
- Patients younger than 18 years of age
- Patients who leave the operating room intubated or are admitted to the intensive care unit while intubated
- Patients with a tracheostomy
- Patients with a history of diaphragmatic paralysis
- Patients with a significant neuromuscular disease, such as ALS, myasthenia gravis, or similar conditions
- Patients with conditions that significantly prevent ultrasound measurements, including marked subcutaneous emphysema, large dressings or bandages covering the measurement area, inability to access the measurement site due to drains or the surgical field, or inability to obtain technically adequate images
- Patients in whom the planned measurements cannot be performed due to clinical instability requiring emergency intubation immediately after ICU admission
- Patients from whom informed consent cannot be obtained, or patients or legally authorized representatives who refuse participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Prof. Dr. Cemil Taşçıoğlu Şehir Hastanesi
Istanbul, Şişli, 34360
Zekeriya Ervatan, +9005055983248, zek.ervatan@gmail.com
About this study
This prospective, non-interventional observational study will evaluate the risk of reintubation in adult postoperative patients admitted to the intensive care unit after major surgery. Reintubation after extubation is an important clinical problem because it may increase complications, prolong mechanical ventilation, and extend intensive care and hospital stay.
The study will include adult patients who are extubated in the operating room and admitted to the intensive care unit with spontaneous breathing. Within the first hours after ICU admission, bedside ultrasound measurements of diaphragm thickness, parasternal intercostal muscle thickness, and lung ultrasound score will be performed. The ROX index will also be calculated using oxygen saturation, inspired oxygen concentration, and respiratory rate. Perioperative fluid balance will be recorded from anesthesia and patient files.
Patients will be followed for 48 to 72 hours after ICU admission to determine whether reintubation is required. The study aims to assess whether respiratory muscle ultrasound findings, lung ultrasound score, ROX index, and perioperative fluid balance can help predict reintubation risk in postoperative ICU patients. No additional treatment or intervention will be applied as part of the study, and all clinical decisions will be made by the responsible intensive care team according to routine clinical practice.
- Conditions
- Postoperative Respiratory Failure, Extubation Failure, Lung Ultrasonography Score, Diaphragm Thickness, Parasternal Intercostal Muscle Thickness
- Keywords
- lung ultrasonography score, Diaphragm thickness, parasternal intercostal muscle thickness, Postoperative Respiratory Failure
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 |
|---|---|---|
| Reintubation group | Reintubation group | |
| No reintubation group | No reintubation group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reintubation Within 72 Hours After Intensive Care Unit Admission
The primary outcome is the development of reintubation within the first 72 hours after admission to the intensive care unit. Reintubation is defined as the need for endotracheal intubation after initial extubation in the operating room and admission to the intensive care unit with spontaneous breathing. The decision for reintubation will be made by the responsible intensive care team according to routine clinical criteria and independently of the study protocol. The outcome will be recorded as yes or no.
Measured: From intensive care unit admission to 72 hours after admission
Secondary outcomes (3)
Diaphragm Thickness at Intensive Care Unit Admission
Diaphragm thickness will be measured by bedside ultrasonography within the first 0-30 minutes after intensive care unit admission. Measurements will be obtained from the same anatomical site with at least three repeated measurements, and the mean value will be used for analysis. Diaphragm thickness values will be evaluated for their association with reintubation within 72 hours.
Measured: Within 0-30 minutes after intensive care unit admission
Parasternal Intercostal Muscle Thickness at Intensive Care Unit Admission
Parasternal intercostal muscle thickness will be measured by bedside ultrasonography within the first 0-30 minutes after intensive care unit admission. At least three repeated measurements will be obtained, and the mean value will be used for analysis. Parasternal intercostal muscle thickness values will be evaluated for their association with reintubation within 72 hours.
Measured: Within 0-30 minutes after intensive care unit admission
Lung Ultrasound Score at Intensive Care Unit Admission
Lung ultrasound score will be assessed using a 12-region lung ultrasound examination. Each region will be scored from 0 to 3, and the total score will range from 0 to 36. Higher scores indicate greater loss of lung aeration. Lung ultrasound score will be evaluated for its association with reintubation within 72 hours.
Measured: Within 0-30 minutes after intensive care unit admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start28 Apr 2026
- Primary completion28 Oct 2026 (estimated)
- Study completion28 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative Respiratory FailureStudies 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
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reyhan Kucuk Erturk, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07672106
- Sponsor's protocol ID
- 312923028
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hattori J, Tanaka A, Kosaka J, Hirao O, Furushima N, Maki Y, Kabata D, Uchiyama A, Egi M, Morimatsu H, Mizobuchi S, Kotake Y, Shintani A, Koyama Y, Yoshida T, Fujino Y. Clinical predictors of extubation failure in postoperative critically ill patients: a post-hoc analysis of a multicenter prospective observational study. BMC Anesthesiol. 2025 Mar 15;25(1):127. doi: 10.1186/s12871-025-02996-1.
PubMed 40089666Masaki H, Suzuki S, Nakayama N, Kobayashi E, Fujii A, Nishiwaki K, Mizuno M, Nakatochi M. Risk markers for postoperative reintubation of intensive care unit patients: A retrospective multicentre study of the National Intensive Care Registry. Intensive Crit Care Nurs. 2025 Apr;87:103956. doi: 10.1016/j.iccn.2025.103956. Epub 2025 Feb 3.
PubMed 39904074
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Reintubation Risk Using Multiple Parameters in Postoperative Intensive Care Unit Patients
- ClinicalTrials.gov ID
- NCT07672106
- Acronym / sponsor ID
- 312923028
- Conditions
- Postoperative Respiratory Failure, Extubation Failure, Lung Ultrasonography Score, Diaphragm Thickness, Parasternal Intercostal Muscle Thickness
- Keywords
- lung ultrasonography score, Diaphragm thickness, parasternal intercostal muscle thickness, Postoperative Respiratory Failure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- 28 Apr 2026 (actual)
- Primary completion
- 28 Oct 2026 (estimated)
- Study completion
- 28 Oct 2026 (estimated)
- First posted
- 26 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.
This prospective, non-interventional observational study will evaluate the risk of reintubation in adult postoperative patients admitted to the intensive care unit after major surgery. Reintubation after extubation is an important clinical problem because it may increase complications, prolong mechanical ventilation, and extend intensive care and hospital stay.
The study will include adult patients who are extubated in the operating room and admitted to the intensive care unit with spontaneous breathing. Within the first hours after ICU admission, bedside ultrasound measurements of diaphragm thickness, parasternal intercostal muscle thickness, and lung ultrasound score will be performed. The ROX index will also be calculated using oxygen saturation, inspired oxygen concentration, and respiratory rate. Perioperative fluid balance will be recorded from anesthesia and patient files.
Patients will be followed for 48 to 72 hours after ICU admission to determine whether reintubation is required. The study aims to assess whether respiratory muscle ultrasound findings, lung ultrasound score, ROX index, and perioperative fluid balance can help predict reintubation risk in postoperative ICU patients. No additional treatment or intervention will be applied as part of the study, and all clinical decisions will be made by the responsible intensive care team according to routine clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reintubation group | – | –Reintubation group |
| No reintubation group | – | –No reintubation group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult postoperative patients aged 18 years and older who are admitted to the anesthesia and reanimation intensive care units after major surgery, including abdominal, vascular, orthopedic, and ear, nose, throat, head and neck surgery. Eligible patients will be those extubated in the operating room and admitted to the intensive care unit with spontaneous breathing during the study period after ethics committee approval.
Key inclusion criteria (6 listed)
- Adult patients aged 18 years and older
- Patients requiring postoperative intensive care follow-up after major surgery, including abdominal, vascular, orthopedic, or ear, nose, throat, head and neck surgery
- Patients extubated in the operating room and admitted to the intensive care unit with spontaneous breathing
- Patients without any clinical condition preventing the planned measurements within the first 0-2 hours after ICU admission (T0 and T1)
- Patients for whom written informed consent can be obtained from the patient or legally authorized representative
Key exclusion criteria (8 listed)
- Patients younger than 18 years of age
- Patients who leave the operating room intubated or are admitted to the intensive care unit while intubated
- Patients with a tracheostomy
- Patients with a history of diaphragmatic paralysis
- Patients with a significant neuromuscular disease, such as ALS, myasthenia gravis, or similar conditions
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
Reintubation Within 72 Hours After Intensive Care Unit Admission
Time frame: From intensive care unit admission to 72 hours after admission
The primary outcome is the development of reintubation within the first 72 hours after admission to the intensive care unit. Reintubation is defined as the need for endotracheal intubation after initial extubation in the operating room and admission to the intensive care unit with spontaneous breathing. The decision for reintubation will be made by the responsible intensive care team according to routine clinical criteria and independently of the study protocol. The outcome will be recorded as yes or no.
3 secondary outcomes
Diaphragm Thickness at Intensive Care Unit Admission
Time frame: Within 0-30 minutes after intensive care unit admission
Parasternal Intercostal Muscle Thickness at Intensive Care Unit Admission
Time frame: Within 0-30 minutes after intensive care unit admission
Lung Ultrasound Score at Intensive Care Unit Admission
Time frame: Within 0-30 minutes after intensive care unit admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Background: PubMed 40089666Hattori J, Tanaka A, Kosaka J, Hirao O, Furushima N, Maki Y, Kabata D, Uchiyama A, Egi M, Morimatsu H, Mizobuchi S, Kotake Y, Shintani A, Koyama Y, Yoshida T, Fujino Y. Clinical predictors of extubation failure in postoperative critically ill patients: a post-hoc analysis of a multicenter prospective observational study. BMC Anesthesiol. 2025 Mar 15;25(1):127. doi: 10.1186/s12871-025-02996-1.
- Background: PubMed 39904074Masaki H, Suzuki S, Nakayama N, Kobayashi E, Fujii A, Nishiwaki K, Mizuno M, Nakatochi M. Risk markers for postoperative reintubation of intensive care unit patients: A retrospective multicentre study of the National Intensive Care Registry. Intensive Crit Care Nurs. 2025 Apr;87:103956. doi: 10.1016/j.iccn.2025.103956. Epub 2025 Feb 3.
- Individual participant dataSharing planned: Undecided
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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.
Prof. Dr. Cemil Taşçıoğlu Şehir Hastanesi
Istanbul, Turkey (Türkiye)
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 Postoperative Respiratory Failure and Extubation Failure, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 11 Aug 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reintubation Within 72 Hours After Intensive Care Unit Admission (time frame: From intensive care unit admission to 72 hours after admission). 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 NCT07672106, which also lists 2 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 11 Aug 2026.