Actively Recruiting
Personalized Tidal Volume in ARDS (VT4HEMOD)
Led by Hospices Civils de Lyon · Updated on 2024-11-19
10
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Personalized Tidal Volume in ARDS (VT4HEMOD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 years old
- Diagnosis of ARDS as defined by the BERLIN definition with PaO2/FiO2 ratio ≤ 150 mm Hg
- Receiving 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
- Presence of an arterial catheter allowing pulse contour cardiac output measurement calibrated with thermodilution
- Presence of a central venous catheter in the superior vena cava territory
- Presence of an esophageal balloon
- Computed tomography scan planned by the attending physician
You will not qualify if you...
- Previous participation in this study
- Acute cor pulmonale
- Receiving extracorporeal membrane oxygenation (ECMO)
- Arterial pH less than 7.21 despite respiratory rate set to a maximum of 35/min
- Presence of pneumothorax or bronchopleural fistula
- Decision to withdraw or withhold life sustaining treatment within 24 hours from inclusion
- Contraindication to transport to imaging facility
- Intracranial hypertension
- Presence of tricuspid or pulmonary mechanical valve
- Presence of tricuspid or pulmonary infective endocarditis
- Presence of pacemaker with intracardiac leads
- Right ventricle tumor
- Complete left bundle branch block
- Presence of intrathoracic metallic device
- Chronic obstructive pulmonary disease (COPD)
- Cardiac arrhythmia
- Vesical pressure greater than 15 mm Hg
- Lower limb amputation
- Inferior vena cava thrombosis
- Participation in another clinical trial exclusion period
- Under legal protective measure
- Not affiliated to social security
- Lack of patient or representative consent
- Pregnancy
- Breastfeeding
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hospices Civils de Lyon - Hôpital de la Croix Rousse - Service de Médecine Intensive Réanimation
Lyon, France, 69004
Actively Recruiting
Research Team
J
Jean-Christophe RICHARD
CONTACT
W
William DANJOU
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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