Assessment of Reintubation Risk Using Multiple Parameters in Postoperative Intensive Care Unit Patients

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 Overview

• Status: Recruiting
• Conditions: Extubation Failure; Parasternal Intercostal Muscle Thickness; Postoperative Respiratory Failure; Lung Ultrasonography Score; Diaphragm Thickness

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Şişli
    • Istanbul, Şişli, Turkey (Türkiye), 34360
      • Recruiting
      • Prof. Dr. Cemil Taşçıoğlu Şehir Hastanesi
      • Contact: Zekeriya Ervatan; Phone Number: +9005055983248; Email: zek.ervatan@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Reintubation group
No reintubation group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From intensive care unit admission to 72 hours after admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Within 0-30 minutes after intensive care unit admission

Collaborators and Investigators

• Sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Publications and helpful links

General 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.
• Masaki 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2026
• Primary Completion (Estimated): October 28, 2026
• Study Completion (Estimated): October 28, 2026

Study Registration Dates

• First Submitted: June 22, 2026
• First Submitted That Met QC Criteria: June 22, 2026
• First Posted (Actual): June 26, 2026

Study Record Updates

• Last Update Posted (Actual): June 26, 2026
• Last Update Submitted That Met QC Criteria: June 22, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Diaphragm thickness; Postoperative Respiratory Failure; lung ultrasonography score; parasternal intercostal muscle thickness
• Other Study ID Numbers: 312923028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No