Regional Diaphragmatic Synchrony Index for Predicting Weaning Outcomes During Pressure Support Ventilation Spontaneous Breathing Trials

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSir Run Run Shaw Hospital

About this trial

The primary aim of this study is to evaluate the predictive value of the inspiratory regional diaphragmatic synchrony index (RDSI-insp) during PSV-SBT for first-attempt weaning failure. Secondary objectives include: (1) assessing the correlation between RDSI-insp and conventional respiratory mechanics and diaphragmatic ultrasound parameters such as RSBI, MIP/NIF, VC, CPF, P0.1, DE, and DTF; (2) comparing differences in RDSI and DPSI between successful and failed weaning groups during inspiration, end-inspiration, and expiration; (3) exploring the association of anterior diaphragmatic dyssynchrony index, posterior/crural dyssynchrony index, and regional time-to-peak dispersion with weaning outcomes; and (4) evaluating the feasibility, analyzable image rate, and repeatability of diaphragmatic speckle-tracking and RDSI calculation in patients undergoing PSV-SBT.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: Age ≥ 18 years.

Mechanical Ventilation Duration: Receiving invasive mechanical ventilation for ≥ 24 hours.

Weaning Readiness: The attending physician has determined that the patient meets the criteria for weaning assessment and plans to conduct a Spontaneous Breathing Trial (SBT) under Pressure Support Ventilation (PSV) mode.

Hemodynamic Stability: Hemodynamically stable prior to the SBT, defined as a mean arterial pressure (MAP) ≥ 65 mmHg, or requiring only low-dose vasopressor support.

Disqualifiers

Known or highly suspected phrenic nerve injury, or unilateral/bilateral diaphragmatic paralysis.

Neuromuscular diseases causing severely restricted spontaneous breathing capacity, as judged by the investigator to be unsuitable for RDSI analysis.

Recent chest or upper abdominal surgery, open trauma, skin infection, or extensive dressing coverage that prevents obtaining a reliable diaphragm ultrasound window.

Significant agitation or severe patient-ventilator asynchrony that prevents the acquisition of continuous and stable respiratory cycles.

Trial population

The study population will consist of adult patients (aged 18 years and older) who have received invasive mechanical ventilation for at least 24 hours and are clinically ready for their first Spontaneous Breathing Trial (SBT) under Pressure Support Ventilation (PSV) mode. Eligible participants must be hemodynamically stable (MAP ≥ 65 mmHg with or without low-dose vasopressors) and have adequate oxygenation (FiO2 ≤ 0.60 and PEEP ≤ 10 cmH2O) to safely undergo the SBT. Patients with known diaphragm paralysis, inadequate ultrasound windows, severe agitation, or those who are pregnant will be excluded. Written informed consent will be obtained from the patient or their legally authorized representative prior to enrollment.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Diagnostic Procedure: Diaphragm Ultrasound and Weaning Assessment

    Device

    Patients undergoing their first Spontaneous Breathing Trial (SBT) under Pressure Support Ventilation (PSV) will receive diaphragm ultrasound examinations. The investigators will measure diaphragm excursion (DE) and thickening fraction (DTF) to calculate the Respiratory Diaphragm-SB Index (RDSI). Conventional weaning parameters (RSBI, MIP, P0.1, etc.) will also be recorded simultaneously. The results will be compared to predict weaning outcomes (successful extubation vs. failure/reintubation).

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Weaning Success1 intervention
Group B: Weaning Failure1 intervention

Trial outcomes

Primary outcomes

1

Rate of first-attempt weaning failure

First-attempt weaning failure, defined as failure of the first PSV-SBT, or extubation following a successful SBT but requiring reintubation within 48 hours due to respiratory failure or failure of airway protection.

Time frame
Up to 48 hours post-extubation (or duration of the first PSV-SBT if failed)

Secondary outcomes

1

Rescue NIV/HFNC within 48 or 72 hours post-extubation

\- Proportion of patients requiring reintubation for any reason (e.g., respiratory failure, decreased airway protection) within 72 hours after extubation.

Time frame
- Up to 72 hours post-extubation
2

- Rescue NIV/HFNC within 48 or 72 hours post-extubation

\- Proportion of patients requiring urgent initiation of non-invasive ventilation (NIV) or high-flow nasal cannula (HFNC) due to respiratory distress or hypoxemia within 48 or 72 hours after extubation.

Time frame
- Up to 48 hours or 72 hours post-extubation
3

- Ventilator-free days at 28 days (D28)

\- The number of days from the first successful weaning and extubation until day 28, during which the patient is alive and free from invasive mechanical ventilation. If the patient dies or remains on mechanical ventilation for more than 28 days, it is recorded as 0 days.

Time frame
- Up to 28 days post-enrollment
4

- Length of stay in the ICU and hospital

\- The number of days from enrollment (day of first SBT) to ICU discharge, and from enrollment to final hospital discharge.

Time frame
From the date of randomization until the date of ICU discharge or hospital discharge, whichever came first, assessed up to 12 months.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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