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Recruiting NCT05406570

Personalized Tidal Volume in ARDS (VT4HEMOD)

No phase Interventional Acute Respiratory Distress Syndrome

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: Standardized ventilation, Personalized ventilation.
Who it may be relevant to
Registry conditions: Acute Respiratory Distress Syndrome. 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
France
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 →

Official title

Personalized Tidal Volume According to Cardiopulmonary Interactions in ARDS

Overview

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)

Interventions

  • Procedure Standardized ventilation
    Patient will be ventilated with tidal volume 6 mL/kg predicted body weight (PBW) and positive end-expiratory pressure (PEEP) according to the PEEP-FiO2 table of the ARMA trial. A CT scan will be performed with this ventilatory setting and the patients will be switched to the other group
  • Procedure Personalized ventilation
    Patient will be ventilated with PEEP according to the PEEP-FiO2 table of the ARMA trial. Tidal volume will be selected as the tidal volume minimizing cardiopulmonary interactions as assessed on arterial pressure tracing, during a VT trial. A CT scan will be performed with this ventilatory setting and the patients will be switched to the other group.

Primary outcome measures

  • Tidal hyperinflation [Time frame: 5 minutes - This endpoint will be assessed 5 minutes after ventilatory adjustment]
Secondary outcome measures (1)
  • Tidal volume [Time frame: 5 hours - This endpoint will be assessed through study completion (approximately 4-5 hours after study inclusion)]

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
  • ECMO
  • 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
  • Right ventricle tumor
  • Complete left bundle block
  • Intrathoracic metallic device
  • COPD
  • Cardiac arrythmia
  • Vesical pressure > 15 mm Hg
  • Lower limb amputation
  • Inferior vena cava thrombosis
  • Patient under an exclusion period relative to participation to another clinical trial
  • Patient under a legal protective measure
  • Patient not affiliated to social security
  • lac of patient/representative consent
  • Pregnancy
  • Breast feeding

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

France · 1 center
  • Hospices Civils de Lyon - Hôpital de la Croix Rousse - Service de Médecine Intensive Réani — Lyon

Identifiers

NCT: NCT05406570 · 69HCL21_1272 · 2021-A02996-35

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗