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Not yet recruiting NCT07697703

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

— Observational Speckle Tracking Diaphragm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Short-term PEEP Step Trial and EDRC Ultrasound Assessment.
Who it may be relevant to
Registry conditions: Speckle Tracking, Diaphragm. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device 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-in

Primary outcome measures

  • Diagnostic Efficacy of EDRC-AUC for Identifying Clinically Significant Dynamic Intrinsic PEEP [Time frame: During the short-term PEEP step trial (each PEEP level is maintained for 5-10 minutes)]
Secondary outcome measures (6)
  • Correlation between EDRC-AUC and Respiratory Drive/Load Indices [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: During the short-term PEEP step trial (each PEEP level maintained for 5-10 minutes) and within 30 minutes post-trial.]

Eligibility criteria

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.

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

  • Haudebourg AF, Maraffi T, Tuffet S, Perier F, de Prost N, Razazi K, Mekontso Dessap A, Carteaux G. Refractory ineffective triggering during pressure support ventilation: effect of proportional assist ventilation with load-adjustable gain factors. Ann Intensive Care. 2021 Oct 20;11(1):147. doi: 10.1186/s13613-021-00935-0. PMID 34669080
  • 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
  • Chao DC, Scheinhorn DJ, Stearn-Hassenpflug M. Patient-ventilator trigger asynchrony in prolonged mechanical ventilation. Chest. 1997 Dec;112(6):1592-9. doi: 10.1378/chest.112.6.1592. PMID 9404759
  • MacIntyre NR, Cheng KC, McConnell R. Applied PEEP during pressure support reduces the inspiratory threshold load of intrinsic PEEP. Chest. 1997 Jan;111(1):188-93. doi: 10.1378/chest.111.1.188. PMID 8996015

Identifiers

NCT: NCT07697703 · 20260627

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗