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

Predicting Extubation Outcomes in Mechanically Ventilated Patients Using PW-TDI Diaphragmatic Kinematics and Traditional Ventilation Parameters: A Prospective Study

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.

Study Overview

• Status: Recruiting
• Conditions: Airway Extubation

Detailed Description

All patients included in the study underwent a spontaneous breathing trial (SBT) using pressure support ventilation (PSV) strategy. This strategy employed pressure support(PS)≤9 cmH2O and positive end-expiratory pressure (PEEP)≤5 cmH2O. The duration of the trial was 30 minutes, and the FiO2 level was set at the same level (≤0.5) used during mechanical ventilation. After successful completion of the spontaneous breathing trial (SBT), ultrasound images were promptly acquired, and the Rapid Shallow Breathing Index (RSBI) was calculated based on the values displayed by the ventilator . Simultaneously, the Acute Physiology and Chronic Health Evaluation II (APACHE II) score was computed and recorded. The decision to extubate, made by the attending physician (unaware of the ultrasound examination parameters), was based on clinical judgment. The primary endpoint event was extubation failure, defined as successful completion of SBT but an inability to sustain spontaneous breathing for more than 48 hours without noninvasive or invasive ventilation support.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Jun Liu, Master; Phone Number: +8617751500920; Email: 17751500920@sina.cn

Study Locations

• China
  • Jiangsu
    • Wuxi, Jiangsu, China, 214122
      • Recruiting
      • Affiliated Hospital of Jiangnan University
      • Contact: Jun Liu, Master; Phone Number: +8617751500920; Email: 17751500920@sina.cn

Participation Criteria

Eligibility Criteria

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

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Affiliated Hospital of Jiangnan University
• Investigators: Study Director: Jun Liu, Master, Affiliated Hospital of Jiangnan University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: November 26, 2023
• First Submitted That Met QC Criteria: December 1, 2023
• First Posted (Actual): December 4, 2023

Study Record Updates

• Last Update Posted (Actual): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 269089632

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Within 60 days of publication, we will share research data, including but not limited to the Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR), and Analytic Code. The aforementioned research data will be uploaded in the form of case record sheets to https://github.com/.
• IPD Sharing Time Frame: within 60 days of publication

IPD Sharing 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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

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