Exploring the Use of Pulse Tissue Doppler in Predicting Extubation Success in Mechanically Ventilated Patients

NCT06154811 | Unknown

• 1 other identifier: 269089632
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Determining the appropriate extubation timing for mechanically ventilated patients is a critical issue in the Intensive Care Unit (ICU). Early or delayed extubation may prolong mechanical ventilation and ICU stay, leading to an increased mortality rate. Currently, extubation timing relies solely on the Spontaneous Breathing Trial (SBT), but its reliability is relatively low, with a extubation failure rate ranging from 10% to 40%. Therefore, accurately predicting potential post-extubation issues and early identification of reasons for SBT trial failure are crucial for improving patient outcomes. Commonly used parameters for assessing readiness for extubation do not fully reflect organ dysfunction, and the investigators plan to utilize comprehensive techniques, including bedside lung and diaphragm ultrasound parameters, to enhance the accuracy of predicting extubation outcomes in patients who pass the SBT trial.

Conditions

Airway Extubation

Outcome Measures

Primary Outcomes (1)

• Successful Removal of Endotracheal Tube

  Extubation success is defined as the successful completion of a Spontaneous Breathing Trial (SBT) and the maintenance of spontaneous breathing without respiratory distress for at least 48 hours, without the need for non-invasive or invasive ventilation.

  The patient undergoes a spontaneous breathing trial, and measurements are taken 30 minutes after the removal of the endotracheal tube.

Study Arms (2)

Extubation Success Group

Extubation success is defined as the successful completion of a Spontaneous Breathing Trial (SBT) and the maintenance of spontaneous breathing without respiratory distress for at least 48 hours, without the need for non-invasive or invasive ventilation.

Extubation Failure Group

Extubation failure is defined as successful Spontaneous Breathing Trial (SBT) but an inability to sustain independent breathing for more than 48 hours without non-invasive or invasive ventilation.

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

From September 01, 2022, to December 30, 2024, continuously enroll patients admitted to both ICU and EICU who, due to various pathophysiological reasons, require mechanical ventilation for more than 24 hours and have successfully passed a spontaneous breathing trial.

You may qualify if:

• Patients were enrolled if participants had been intubated and mechanically ventilated for more than 24 hours and were ready for participants first SBT according to ICU weaning criteria.

You may not qualify if:

• paralytic drugs taken within 24 hours prior to the trial;
• diagnosis of diaphragmatic paralysis or paradoxical movement of the hemidiaphragm detected by ultrasound or poor imaging quality;
• Pregnancy;
• Ascites;
• age\<18years;
• Post-thoracotomy;
• Existence of pneumothorax;
• presence of large pleural effusion, subcutaneous emphysema, flail chest or right-sided rib fractures;
• presence of neuromuscular diseases.

Sponsors & Collaborators

• Affiliated Hospital of Jiangnan University: lead

Study Sites (1)

Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu, 214122, China

RECRUITING

Study Officials

• Jun Liu, Master

  Affiliated Hospital of Jiangnan University

  STUDY DIRECTOR

Central Study Contacts

Jun Liu, Master

CONTACT

+8617751500920; 17751500920@sina.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2023
• First Posted: December 4, 2023
• Study Start: September 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 8, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: within 60 days of publication
• Access Criteria: individual patient data(IPD) Sharing Standards Purpose: Data is solely for lawful, scientific research, not commercial or illegal use. Compliance: Usage complies with regulations, ethics, privacy principles. Research Proposal: Utilizing researchers submit detailed proposals. Ethical Review: Proposals need ethics committee approval. Data Security: Researchers ensure secure data handling. De-identification: Data provided is de-identified for privacy. Reporting Obligations: Researchers report progress and share results. Sharing Plan Updates: Data providers can update plans. Collaboration Opportunities: Data providers may collaborate on analysis, publications. Legal Responsibilities: Researchers follow legal regulations, preventing misuse.

Locations

CN (1)