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End-Expiratory Diaphragmatic Residual Contraction Index for Identifying Intrinsic PEEP and Assisting PEEP Titration: A Prospective Physiological Study

5 juillet 2026 mis à jour par: Huiqing Ge, Sir Run Run Shaw Hospital
This study proposes the End-expiratory Diaphragmatic Residual Contraction (EDRC) index to quantify residual diaphragmatic activity at end-expiration during Pressure Support Ventilation (PSV) mode. The study aims to validate the relationship between EDRC and dynamic intrinsic PEEP (PEEPi), triggering load, patient-ventilator asynchrony, and PEEP responsiveness through a brief, standardized PEEP titration trial conducted within a clinically safe range. This will provide a basis for subsequent individualized PEEP setting guided by EDRC.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Observationnel

Inscription (Estimé)

100

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Huiqing Ge, MD
  • Numéro de téléphone: +8613588706787
  • E-mail: gehq@zju.edu.cn

Sauvegarde des contacts de l'étude

  • Nom: YIqing Xu, Master
  • Numéro de téléphone: +86 13634115344
  • E-mail: xuyiqing@srrsh.com

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

The study population will consist of adult patients ($\ge$ 18 years) admitted to the Intensive Care Unit (ICU) who are receiving invasive mechanical ventilation in Pressure Support Ventilation (PSV) mode. Participants will be recruited from the ICU at [Insert Name of Hospital/Institution].

The population is characterized by patients who are clinically assessed as having a risk of dynamic intrinsic PEEP (PEEPi,dyn) or are undergoing a spontaneous breathing trial (SBT) as part of the weaning process. All enrolled patients will have an indwelling esophageal balloon catheter placed for the measurement of esophageal pressure (Pes), which serves as the reference standard for respiratory mechanics.

Patients will be screened for eligibility based on hemodynamic stability and the ability to tolerate the study procedures. Specific exclusion criteria include pregnancy, severe esophageal pathology, severe hypoxemia, and conditions precluding diaphragmatic ultrasound imaging (e.g., chest wall tra

La description

Inclusion Criteria:

  • Age ≥ 18 years. Patients receiving invasive mechanical ventilation in Pressure Support Ventilation (PSV) mode.

Clinically assessed as having a risk of dynamic intrinsic PEEP (PEEPi,dyn) or experiencing difficult weaning from mechanical ventilation.

Presence of an indwelling esophageal balloon catheter (for reference standard measurements).

Provision of written informed consent from the patient or legally authorized representative.

Exclusion Criteria:

  • Pregnancy or lactation. Known esophageal diseases (e.g., esophageal varices, strictures, recent esophageal surgery) or contraindications to esophageal catheter placement.

Severe hemodynamic instability (e.g., requiring high-dose vasoactive support, uncontrolled arrhythmias).

Severe hypoxemia (PaO2/FiO2 < 100 mmHg) or severe hypercapnia with hemodynamic compromise at baseline.

Conditions precluding ultrasound assessment of the diaphragm (e.g., extensive chest wall trauma, large pleural effusion, severe subcutaneous emphysema).

Active spontaneous breathing with severe patient-ventilator asynchrony that cannot be stabilized during the trial.

Anticipated extubation or withdrawal of life-sustaining treatment within the next 24 hours.

Participation in another interventional clinical trial within the last 30 days.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
Patients Undergoing PEEP Step Trial and EDRC Assessment
All enrolled patients will receive a standardized, short-term PEEP step trial while in Pressure Support Ventilation (PSV) mode. The trial consists of sequentially applying PEEP levels of Baseline, -2, +2, +4, and +6 cmH2O relative to the set PEEP. At each step, respiratory mechanics and patient-ventilator synchrony will be monitored. The primary intervention of interest is the assessment of End-Expiratory Diaphragmatic Residual Contraction (EDRC) via ultrasound to identify the presence of intrinsic PEEP (PEEPi) and to determine the optimal level of extrinsic PEEP that minimizes diaphragmatic effort and asynchrony.
Dispositif: Short-term PEEP Step Trial and EDRC Ultrasound Assessment
This intervention involves a standardized, short-term PEEP step trial combined with a novel physiological assessment. During the trial, external PEEP is systematically adjusted in 2 cmH2O increments (Baseline, -2, +2, +4, +6 cmH2O) while maintaining stable Pressure Support Ventilation (PSV) settings. Simultaneously, the End-Expiratory Diaphragmatic Residual Contraction (EDRC) index is evaluated using diaphragm ultrasound speckle tracking. This distinguishes the intervention by providing a non-invasive, real-time quantification of residual diaphragmatic tension at end-expiration, which serves as a surrogate marker for dynamic intrinsic PEEP (PEEPi) and trigger load, distinguishing it from traditional static measurements or esophageal manometry alone.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Diagnostic Efficacy of EDRC-AUC for Identifying Clinically Significant Dynamic Intrinsic PEEP
Délai: During the short-term PEEP step trial (each PEEP level is maintained for 5-10 minutes)
The primary outcome is the diagnostic efficacy of the End-Expiratory Diaphragmatic Residual Contraction Area Under the Curve (EDRC-AUC) in identifying clinically significant dynamic intrinsic PEEP (PEEPi,dyn ≥ 5 cmH2O) in patients undergoing Pressure Support Ventilation (PSV). The diagnostic performance will be evaluated using Receiver Operating Characteristic (ROC) curve analysis, reporting the Area Under the Curve (AUC), optimal cut-off value, sensitivity, specificity, positive predictive value, and negative predictive value, with esophageal manometry and flow curves as the reference standard.
During the short-term PEEP step trial (each PEEP level is maintained for 5-10 minutes)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Correlation between EDRC-AUC and Respiratory Drive/Load Indices
Délai: During the short-term PEEP step trial (each PEEP level maintained for 5-10 minutes) and within 30 minutes post-trial
To evaluate the correlation (using Pearson or Spearman correlation coefficients) between the End-Expiratory Diaphragmatic Residual Contraction Area Under the Curve (EDRC-AUC)
During the short-term PEEP step trial (each PEEP level maintained for 5-10 minutes) and within 30 minutes post-trial
Incidence of Patient-Ventilator Asynchrony Events
Délai: During the short-term PEEP step trial (each PEEP level maintained for 5-10 minutes) and within 30 minutes post-trial.
To record and compare the total incidence and distribution of patient-ventilator asynchrony events across different PEEP levels. Specific events include:Ineffective triggering;Double triggering;Auto-triggering;Short or long cycling.
During the short-term PEEP step trial (each PEEP level maintained for 5-10 minutes) and within 30 minutes post-trial.
Agreement between EDRC-Guided PEEP and Esophageal Manometry-Guided PEEP
Délai: During the short-term PEEP step trial (each PEEP level maintained for 5-10 minutes) and within 30 minutes post-trial.
To compare the optimal PEEP level determined by the EDRC minimization principle with the optimal PEEP level determined by esophageal manometry (minimizing driving pressure or PTP). Bland-Altman analysis will be used to evaluate the mean bias and limits of agreement between the two methods.
During the short-term PEEP step trial (each PEEP level maintained for 5-10 minutes) and within 30 minutes post-trial.
Trends in Diaphragmatic Contraction Dynamics Across PEEP Levels
Délai: During the short-term PEEP step trial (each PEEP level maintained for 5-10 minutes) and within 30 minutes post-trial.
To observe and describe the dynamic trends of diaphragm thickening fraction (DTF) and the EDRC index across all phases of the PEEP step trial (Baseline, -2, +2, +4, +6 cmH2O), assessing the bidirectional effects of extrinsic PEEP on diaphragmatic load.
During the short-term PEEP step trial (each PEEP level maintained for 5-10 minutes) and within 30 minutes post-trial.
Feasibility and Inter-Observer Reliability of EDRC Ultrasound Measurements
Délai: During the short-term PEEP step trial (each PEEP level maintained for 5-10 minutes) and within 30 minutes post-trial.
Feasibility: The proportion of patients from whom analyzable ultrasound images were successfully obtained; Reproducibility: The intra-class correlation coefficient (ICC) for EDRC-AUC measurements between different operators (inter-observer) and by the same operator at different time points (intra-observer).
During the short-term PEEP step trial (each PEEP level maintained for 5-10 minutes) and within 30 minutes post-trial.
Adverse Events During the PEEP Step Trial
Délai: During the short-term PEEP step trial (each PEEP level maintained for 5-10 minutes) and within 30 minutes post-trial.

To document any clinical adverse events occurring during the PEEP titration process, including:

Hemodynamic instability (e.g., systolic blood pressure decrease >20% or increased requirement for vasoactive drugs); Severe hypoxemia (SpO2 < 88% lasting >1 minute); Severe arrhythmias; Significant respiratory distress or intolerance requiring premature termination of the trial.
During the short-term PEEP step trial (each PEEP level maintained for 5-10 minutes) and within 30 minutes post-trial.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Sir Run Run Shaw Hospital

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

21 août 2026

Achèvement primaire (Estimé)

24 août 2027

Achèvement de l'étude (Estimé)

3 septembre 2027

Dates d'inscription aux études

Première soumission

5 juillet 2026

Première soumission répondant aux critères de contrôle qualité

5 juillet 2026

Première publication (Réel)

13 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

13 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

5 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • 20260627

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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