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

Official title

Regional Diaphragmatic Synchrony Index for Predicting Weaning Outcomes During Pressure Support Ventilation Spontaneous Breathing Trials: A Prospective Observational Study

Overview

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.

Interventions

• Device Diagnostic Procedure: Diaphragm Ultrasound and Weaning Assessment
  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).

Primary outcome measures

• Rate of first-attempt weaning failure [Time frame: Up to 48 hours post-extubation (or duration of the first PSV-SBT if failed)]

Secondary outcome measures (7)

• Rescue NIV/HFNC within 48 or 72 hours post-extubation [Time frame: - Up to 72 hours post-extubation]
• - Rescue NIV/HFNC within 48 or 72 hours post-extubation [Time frame: - Up to 48 hours or 72 hours post-extubation]
• - Ventilator-free days at 28 days (D28) [Time frame: - Up to 28 days post-enrollment]
• - Length of stay in the ICU and hospital [Time frame: 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 [Time frame: From the date of randomization until the date of ICU discharge or death, whichever came first, assessed up to 12 months.]
• - Correlation between RDSI and conventional respiratory mechanics/diaphragm ultrasound parameters [Time frame: At the end of the first PSV-SBT (approximately 30 to 120 minutes post-initiation)]
• - Feasibility and reliability of RDSI image acquisition and speckle tracking [Time frame: At the end of the first PSV-SBT, up to 120 minutes post-initiation (upon image completion)]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Other

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• 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
• 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
• 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
• 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
• 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 V PMID 36286317

Identifiers

NCT: NCT07733102 · 20260625

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗