Regional Diaphragmatic Synchrony Index for Predicting Weaning Outcomes During Pressure Support Ventilation Spontaneous Breathing Trials
2026년 7월 23일 업데이트: Huiqing Ge, Sir Run Run Shaw Hospital
Regional Diaphragmatic Synchrony Index for Predicting Weaning Outcomes During Pressure Support Ventilation Spontaneous Breathing Trials: A Prospective Observational Study
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.
연구 개요
상태
아직 모집하지 않음
연구 유형
관찰
등록 (추정된)
110
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Huiqing Ge, MD
- 전화번호: +8613588706787
- 이메일: gehq@zju.edu.cn
연구 연락처 백업
- 이름: YIqing Xu, Master
- 전화번호: +86 13634115344
- 이메일: xuyiqing@srrsh.com
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
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아니
샘플링 방법
확률 샘플
연구 인구
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.
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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.
|
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).
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|
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.
|
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).
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Rate of first-attempt weaning failure
기간: Up to 48 hours post-extubation (or duration of the first PSV-SBT if failed)
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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)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Rescue NIV/HFNC within 48 or 72 hours post-extubation
기간: - Up to 72 hours post-extubation
|
- Proportion of patients requiring reintubation for any reason (e.g., respiratory failure, decreased airway protection) within 72 hours after extubation.
|
- Up to 72 hours post-extubation
|
|
- Rescue NIV/HFNC within 48 or 72 hours post-extubation
기간: - Up to 48 hours 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.
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- Up to 48 hours or 72 hours post-extubation
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- Ventilator-free days at 28 days (D28)
기간: - Up to 28 days post-enrollment
|
- 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.
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- Up to 28 days post-enrollment
|
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- Length of stay in the ICU and hospital
기간: From the date of randomization until the date of ICU discharge or hospital discharge, whichever came first, assessed up to 12 months.
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- The number of days from enrollment (day of first SBT) to ICU discharge, and from enrollment to final hospital discharge.
|
From the date of randomization until the date of ICU discharge or hospital discharge, whichever came first, assessed up to 12 months.
|
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- ICU mortality and in-hospital mortality
기간: From the date of randomization until the date of ICU discharge or death, whichever came first, assessed up to 12 months.
|
- The proportion of patients who die during their ICU stay and during the entire hospital stay (until discharge).
|
From the date of randomization until the date of ICU discharge or death, whichever came first, assessed up to 12 months.
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- Correlation between RDSI and conventional respiratory mechanics/diaphragm ultrasound parameters
기간: At the end of the first PSV-SBT (approximately 30 to 120 minutes post-initiation)
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- Assessment of the statistical correlation between the novel RDSI index and conventional weaning predictors, including Rapid Shallow Breathing Index (RSBI), Maximum Inspiratory Pressure (MIP/NIF), Vital Capacity (VC), Cough Peak Flow (CPF), Airway Occlusion Pressure (P0.1),
Diaphragmatic Excursion (DE), and Diaphragm Thickening Fraction (DTF).
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At the end of the first PSV-SBT (approximately 30 to 120 minutes post-initiation)
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- Feasibility and reliability of RDSI image acquisition and speckle tracking
기간: At the end of the first PSV-SBT, up to 120 minutes post-initiation (upon image completion)
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- Assessment of the acquisition rate of diaphragm ultrasound images, the analyzability rate (proportion of successful speckle tracking analysis), and the inter-observer and intra-observer measurement agreement (Intraclass Correlation Coefficient, ICC).
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At the end of the first PSV-SBT, up to 120 minutes post-initiation (upon image completion)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
- 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.
- 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.
- 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.
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 8월 23일
기본 완료 (추정된)
2027년 8월 21일
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2027년 8월 30일
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