Diaphragmatic Speckle Tracking to Guide Diaphragm-Protective Ventilatory Support: A Study of Feasibility and Efficacy.

Not Applicable

Not yet recruiting

• Conditions: Respiratory Failure

• Registration Number: NCT06996665
• Lead Sponsor: Sir Run Run Shaw Hospital

Brief Summary

The goal of this clinical trial is to evaluate the effectiveness of diaphragmatic speckle tracking ultrasound in guiding diaphragm-protective ventilation in mechanically ventilated patients, and to assess its impact on extubation success rates and diaphragmatic function preservation. The main research questions include:

Can diaphragmatic speckle tracking ultrasound improve diaphragmatic function and reduce the risk of complications associated with mechanical ventilation?

Can real-time adjustment of ventilation parameters based on speckle tracking feedback improve extubation success rates?

Researchers will compare the PEEP strategy guided by diaphragmatic speckle tracking ultrasound with conventional PEEP settings in mechanical ventilation to evaluate the effectiveness of this novel approach in preserving diaphragmatic function and improving patient outcomes.

Participants will:

Receive either ultrasound-guided ventilation or conventional ventilation daily during mechanical ventilatory support.

Keep a daily record of symptoms, ventilation adjustments, and extubation outcomes.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-03
• Study First Submitted QC: 2025-05-29
• Last Update Submitted: 2025-05-29
• Study First Posted: 2025-05-30
• Last Update Posted: 2025-05-30
• Study Start: 2025-06-01
• Primary Completion: 2025-12-30
• Study Completion: 2026-02-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Age ≥18 years old.
2. Clear diagnosis of respiratory failure requiring respiratory support.
3. Expected duration of respiratory support ≥24 hours or (high-flow/non-invasive ventilation) ≥48 hours.
4. Voluntary participation in this study and signed informed consent. If the participant is unable to read or sign the informed consent form due to incapacity (e.g., unconsciousness), the legal guardian must act as a proxy in the informed consent process and sign the form. If the participant cannot read the consent form (e.g., illiterate participants), a witness must observe the informed consent process and sign the form.

Exclusion Criteria

1. Severe chest wall deformities or diaphragmatic paralysis.
2. End-stage disease with a predicted life expectancy of less than 24 hours.
3. Inability to acquire STE (strains and echoes) images (e.g., severe subcutaneous emphysema, position limitations).
4. Vulnerable groups other than critically ill patients/elderly/illiterate individuals, including those with mental disorders, cognitive impairments, pregnant women, etc.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
First successful extubation time	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 months.
Incidence of ventilator-associated events (VAE)	through study completion, an average of 1 month
Total MV duration (h)	through study completion, an average of 1 month

Secondary Outcome Measures

Name	Time	Method
Adverse events including pneumothorax, hemodynamic instability, and other complications	At baseline (upon enrollment), 1 hour / 6 hours / 24 hours after intervention, and during daily morning assessments until extubation or day 28.
Arterial blood gas analysis (ABG analysis)	At baseline (upon enrollment), 1 hour / 6 hours / 24 hours after intervention, and during daily morning assessments until extubation or day 28.
EIT monitoring of regional ventilation distribution (center-to-periphery ventilation ratio)	At baseline (upon enrollment), 1 hour / 6 hours / 24 hours after intervention, and during daily morning assessments until extubation or day 28.
TGF-β1 in blood samples	At baseline (upon enrollment) and extubation or day 28
Diaphragmatic ultrasound parameters (maximum displacement, thickening fraction, etc.)	At baseline (upon enrollment), 1 hour / 6 hours / 24 hours after the intervention, and daily morning assessments until extubation or day 28.
Transpulmonary pressure	At baseline (upon enrollment), 1 hour / 6 hours / 24 hours after the intervention, and daily morning assessments until extubation or day 28.
Grem2 in blood samples	At baseline (upon enrollment) and extubation or day 28
Smad3 in blood samples	At baseline (upon enrollment) and extubation or day 28

Trial Locations

Locations (1)

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine; 🇨🇳 Hang Zhou, Zhejiang, China