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

NCT07672106 | Recruiting

• 1 other identifier: 312923028
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Diaphragm Thickness at Intensive Care Unit Admission

  Within 0-30 minutes after intensive care unit admission

• Parasternal Intercostal Muscle Thickness at Intensive Care Unit Admission

  Within 0-30 minutes after intensive care unit admission

• Lung Ultrasound Score at Intensive Care Unit Admission

  Within 0-30 minutes after intensive care unit admission

Study Arms (2)

Reintubation group

Reintubation group

No reintubation group

No reintubation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Prof. Dr. Cemil Taşçıoğlu Şehir Hastanesi

Istanbul, Şişli, 34360, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• 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.

  PMID: 40089666 BACKGROUND

• 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.

  PMID: 39904074 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 26, 2026
• Study Start: April 28, 2026
• Primary Completion (Estimated): October 28, 2026
• Study Completion (Estimated): October 28, 2026
• Last Updated: June 26, 2026

Record last verified: 2026-06

Locations

TU (1)