Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

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

23. Juli 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

110

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Huiqing Ge, MD
  • Telefonnummer: +8613588706787
  • E-Mail: gehq@zju.edu.cn

Studieren Sie die Kontaktsicherung

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Wahrscheinlichkeitsstichprobe

Studienpopulation

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.

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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.
Gerät: 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).
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.
Gerät: 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).

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Rate of first-attempt weaning failure
Zeitfenster: Up to 48 hours post-extubation (or duration of the first PSV-SBT if failed)
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)

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Sir Run Run Shaw Hospital

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

23. August 2026

Primärer Abschluss (Geschätzt)

21. August 2027

Studienabschluss (Geschätzt)

30. August 2027

Studienanmeldedaten

Zuerst eingereicht

5. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

23. Juli 2026

Zuerst gepostet (Tatsächlich)

29. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

29. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

23. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • 20260625

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Abonnieren