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

NCT07733102 | Not Yet Recruiting

• 1 other identifier: 20260625
• Study Type: observational
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Diaphragm; Speckle Tracking

Outcome Measures

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.

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

Secondary Outcomes (7)

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

  - Up to 72 hours post-extubation

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

  - Up to 48 hours or 72 hours post-extubation

• - Ventilator-free days at 28 days (D28)

  - Up to 28 days post-enrollment

• - Length of stay in the ICU and hospital

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

• - ICU mortality and in-hospital mortality

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

Study Arms (2)

Weaning Success

Patients who successfully pass the first PSV-SBT and remain free from reintubation or rescue non-invasive ventilation (NIV)/high-flow nasal cannula (HFNC) for at least 48 hours post-extubation due to respiratory failure or failure of airway protection.

Device: Diagnostic Procedure: Diaphragm Ultrasound and Weaning Assessment

Weaning Failure

Patients who fail the first PSV-SBT, or those who pass the SBT but require reintubation or rescue NIV/HFNC within 48 hours post-extubation due to respiratory failure or failure of airway protection.

Device: Diagnostic Procedure: Diaphragm Ultrasound and Weaning Assessment

Interventions

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).

Weaning Failure; Weaning Success

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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.
• Oxygenation Criteria: Oxygenation status permits an SBT, typically defined as FiO2 ≤ 0.60 and PEEP ≤ 10 cmH2O, or meeting the standard weaning assessment criteria of the participating institution.

You may not qualify if:

• 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.
• Undrained pneumothorax, or conditions deemed unsuitable for ultrasound examination as judged by the attending physician.
• Pregnant patients.
• The patient or their legally authorized representative refuses to participate in the study.

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead

Related Publications (5)

• Mahmoodpoor A, Fouladi S, Ramouz A, Shadvar K, Ostadi Z, Soleimanpour H. Diaphragm ultrasound to predict weaning outcome: systematic review and meta-analysis. Anaesthesiol Intensive Ther. 2022;54(2):164-174. doi: 10.5114/ait.2022.117273.

  PMID: 35792111 RESULT

• Parada-Gereda HM, Tibaduiza AL, Rico-Mendoza A, Molano-Franco D, Nieto VH, Arias-Ortiz WA, Perez-Teran P, Masclans JR. Effectiveness of diaphragmatic ultrasound as a predictor of successful weaning from mechanical ventilation: a systematic review and meta-analysis. Crit Care. 2023 May 5;27(1):174. doi: 10.1186/s13054-023-04430-9.

  PMID: 37147688 RESULT

• Umbrello M, Formenti P, Longhi D, Galimberti A, Piva I, Pezzi A, Mistraletti G, Marini JJ, Iapichino G. Diaphragm ultrasound as indicator of respiratory effort in critically ill patients undergoing assisted mechanical ventilation: a pilot clinical study. Crit Care. 2015 Apr 13;19(1):161. doi: 10.1186/s13054-015-0894-9.

  PMID: 25886857 RESULT

• Park JE, Kim DY, Park JW, Jung YJ, Lee KS, Park JH, Sheen SS, Park KJ, Sunwoo MH, Chung WY. Development of a Machine Learning Model for Predicting Weaning Outcomes Based Solely on Continuous Ventilator Parameters during Spontaneous Breathing Trials. Bioengineering (Basel). 2023 Oct 5;10(10):1163. doi: 10.3390/bioengineering10101163.

  PMID: 37892893 RESULT

• Thille AW, Gacouin A, Coudroy R, Ehrmann S, Quenot JP, Nay MA, Guitton C, Contou D, Labro G, Reignier J, Pradel G, Beduneau G, Dangers L, Saccheri C, Prat G, Lacave G, Sedillot N, Terzi N, La Combe B, Mira JP, Romen A, Azais MA, Rouze A, Devaquet J, Delbove A, Dres M, Bourenne J, Lautrette A, de Keizer J, Ragot S, Frat JP; REVA Research Network. Spontaneous-Breathing Trials with Pressure-Support Ventilation or a T-Piece. N Engl J Med. 2022 Nov 17;387(20):1843-1854. doi: 10.1056/NEJMoa2209041. Epub 2022 Oct 26.

  PMID: 36286317 RESULT

Central Study Contacts

Huiqing Ge, MD

CONTACT

+8613588706787; gehq@zju.edu.cn

YIqing Xu, Master

CONTACT

+86 13634115344; xuyiqing@srrsh.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Respiratory Medicine

Study Record Dates

• First Submitted: July 5, 2026
• First Posted: July 29, 2026
• Study Start (Estimated): August 23, 2026
• Primary Completion (Estimated): August 21, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share