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Clinical Trials/NCT05406570
NCT05406570
Recruiting
Not Applicable

Personalized Tidal Volume According to Cardiopulmonary Interactions in ARDS

Hospices Civils de Lyon1 site in 1 country10 target enrollmentDecember 29, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Respiratory Distress Syndrome
Sponsor
Hospices Civils de Lyon
Enrollment
10
Locations
1
Primary Endpoint
Tidal hyperinflation
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

Treatment of acute respiratory distress syndrome (ARDS) relies on invasive mechanical ventilation with supposedly protective settings (low tidal volume ventilation). Mortality of ARDS remains high in observational studies (40 to 50%). Approximately 30% of ARDS patients exhibit tidal hyperinflation despite low tidal volume ventilation, suggesting that personalization of tidal volume is required to improve ARDS prognostic. To date, reliable bedside tools to adjust tidal volume are lacking. Excessive tidal volume can be detected using computed tomography by quantification of tidal hyperinflation, but this technique is reserved to research studies and requires patient transport to imaging facility.

Mechanical ventilation generates cardio-pulmonary interaction, whose magnitude is influenced by tidal volume and respiratory system characteristics. Pulse pressure variation is a bedside tool with potential to quantify cardio-pulmonary interactions. Increasing tidal volume will decrease right ventricular preload and increase right ventricular afterload, hence maximizing cardio-pulmonary interactions.

The investigators hypothesize that pulse pressure variation might help to detect excessive tidal volume during a tidal volume challenge (i.e. stepwise increase in tidal volume)

Registry
clinicaltrials.gov
Start Date
December 29, 2022
End Date
December 2026
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age greater then 18 years old
  • ARDS according to the BERLIN definition with PaO2/FiO2 ratio ≤ 150 mm Hg
  • invasive mechanical ventilation in volume controlled mode with tidal volume set to 6 ml/kg predicted body weight
  • use of sedation and neuromuscular-blocking agents
  • arterial catheter allowing computation of pulse contour cardiac output calibrated with thermodilution
  • central venous catheter implanted in the superior vena cava territory
  • esophageal balloon
  • Computed tomography planned by attending physician

Exclusion Criteria

  • Previous inclusion in current study
  • Acute cor pulmonale
  • Arterial pH \< 7.21 despite respiratory rate set to a maximum of 35/min
  • Pneumothorax or bronchopleural fistula
  • Decision to withdraw or withhold life sustaining treatment with 24 hours from inclusion
  • Contra-indication of transport to imaging facility
  • Intracranial hypertension
  • Tricuspid or pulmonary mechanical valve
  • Tricuspid or pulmonary infective endocarditis
  • Pace maker with intracardiac leads

Outcomes

Primary Outcomes

Tidal hyperinflation

Time Frame: 5 minutes - This endpoint will be assessed 5 minutes after ventilatory adjustment

Difference between hyperinflated volume in computed tomography images acquired at end-inspiration (defined by the volume of voxels with CT-number \< -900) and hyperinflated volume in computed tomography images acquired at end-expiration (defined by the volume of voxels with CT-number \< -900). This difference will be standardized to predicted body weight using the formula of the ARMA trial.

Secondary Outcomes

  • Tidal volume(5 hours - This endpoint will be assessed through study completion (approximately 4-5 hours after study inclusion))

Study Sites (1)

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