Extubation Guided by Bedside Ultrasound

NCT05674812 | Completed FDA Device

• 1 other identifier: TJMZ2022-M001
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

The aging of the global population has led to an increased number of surgical procedures being performed on elderly patients. However, with aging, the main structure and function of the lungs undergo progressive changes involving lung elasticity , impaired defense mechanisms, weakened respiratory muscle strength, and lessened responsiveness of the lungs to anesthesia . Smetana showed that nearly 33% of patients older than 65 years of age who undergo surgical procedures develop postoperative pulmonary complications. It can be seen that elderly patients are themselves at high risk of pulmonary complications .Common postoperative pulmonary complications include pleural effusion, atelectasis, pneumonia, acute respiratory distress syndrome, cardiogenic pulmonary edema, and postoperative need for mechanical ventilation.This can lead to prolonged hospitalization, increased economic burden on patients, and increased long-term mortality . Therefore, accurately determining factors influencing successful postoperative weaning and extubation in elderly patients is crucial to reduce complications. Clinical practice guidelines for critically ill patients in general recommend a well-defined, albeit imperfect, protocolized weaning and extubation procedure, including the evaluation of weaning readiness, spontaneous breathing trial (SBT) assessment, extubation, and consideration of prophylactic noninvasive ventilation or high-flow nasal oxygen.However, even if the SBT is successful, 3%-30% of patients still need to be reintubated due to respiratory distress after removal of the endotracheal tube . Predicting successful extubation in these patients is difficult. Predicting successful extubation remains difficult even after a successful SBT. The decision often relies on SBT results and clinical judgment, which can be unreliable. Identifying objective factors associated with extubation failure is therefore essential. Lung ultrasound score (LUS)has been shown to accurately predict extubation failure by detecting significant pulmonary edema during SBT,and diaphragm excursion (DE)can be used to quantitatively assess diaphragm activity to assess extubation success. However, these studies primarily involved ICU patients with mixed medical and surgical conditions. Data specifically focusing on elderly surgical patients in the Post-Anesthesia Care Unit (PACU) are limited.Given this background, we conducted this multicenter prospective observational study to investigate the association between lung ultrasound parameters (LUS, DE), oxygenation index (OI), and other clinical and laboratory factors with extubation failure specifically in elderly surgical patients recovering in the PACU.

Conditions

Respiratory Insufficiency; Ventilator Weaning; Postoperative Complications

Keywords

Weaning; Ultrasound; Elderly surgical patients

Outcome Measures

Primary Outcomes (1)

• Incidence of extubation failure within 48 hours after planned extubation

  Extubation failure was defined as the need for other respiratory support (HFNC, NIV, reintubation) within 48 hours ofplanned extubation.

  Within 48 hours after extubation

Secondary Outcomes (4)

• Mechanical ventilation duration

  At the end of the operation, the patient was transferred to the PACU for a short period of ventilatory support, and the last minute of extubation was allowed after awakening and muscle strength recovery

• PACU/hospital stay

  Patients were observed from the first minute of entering the PACU to the last minute of leaving the PACU/Patients were hospitalized from the first to the last day

• postoperative pulmonary complications

  Within seven days of surgery

• mortality

  Mortality within 30 days of hospitalization

Study Arms (2)

Extubation Failure

Patients meeting extubation failure criteria within 48 hours after planned extubation

Diagnostic Test: Multimodal pre-extubation risk assessment in elderly surgical patients

Extubation Success

Patients maintaining spontaneous breathing for \>48 hours after extubation

Diagnostic Test: Multimodal pre-extubation risk assessment in elderly surgical patients

Interventions

Multimodal pre-extubation risk assessment in elderly surgical patients DIAGNOSTIC_TEST

This observational cohort study evaluates risk factors for extubation failure in elderly surgical patients. All participants receive standard pre-extubation clinical assessments per institutional protocol, including LUS、DE and oxygenation index (PaO₂/FiO₂), arterial blood gas analysis, and the patients'laboratory results before and after surgery. The association between these parameters and extubation failure will be analyzed.

Extubation Failure; Extubation Success

Eligibility Criteria

• Age: 65 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Elderly patients with mechanical ventilation after general anesthesia

Sponsors & Collaborators

• Lili Jia: lead
• Tianjin Forth Central Hospital: collaborator
• Tianjin Fifth Central Hospital: collaborator
• Tianjin TEDA Hospital: collaborator
• The First Affiliated Hospital of Shanxi Medical University: collaborator
• Shanxi Province Cancer Hospital: collaborator

Study Sites (1)

TianJin First Central Hospital

Tianjin, Tianjin Municipality, 300192, China

Location

MeSH Terms

Conditions

Respiratory Insufficiency; Postoperative Complications

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wenli Yu

  Tian Jin First Center Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: sponsor

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: January 6, 2023
• Study Start: December 1, 2022
• Primary Completion: June 30, 2024
• Study Completion: August 1, 2024
• Last Updated: September 3, 2025

Record last verified: 2025-08

Locations

CN (1)