Status:
UNKNOWN
Paramedical Protocol for Ventilation in Acute Respiratory Distress Syndrome
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Acute Respiratory Distress Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Acute respiratory distress syndrome (ARDS) is a frequent pathology in intensive care (around 10% of patients admitted to intensive care and almost a quarter of patients on mechanical ventilation) and ...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Intensive care hospitalization;
- Intubation with artificial ventilation;
- ARDS evolving for less than 72 hours. ARDS criteria according to the Berlin definition, as follows:
- Exposure to a risk factor for ARDS or onset/aggravation of pulmonary symptoms within the previous 7 days ;
- Respiratory distress not fully explained by cardiac failure or volume overload, with exclusion of hydrostatic edema in the absence of exposure to a risk factor for ARDS;
- Hypoxemia with PaO2/FiO2 ratio \< 300 mm Hg under PEEP ≥ 5 cmH2O ;
- Bilateral opacities on chest X-ray, lung ultrasound or chest CT, not fully explained by pleural effusions, atelectasis or nodules.
- Blood pressure monitoring
- Affiliation to the social security system.
- Written informed consent (patient, relative) or inclusion in emergency situation.
Exclusion
- Long-term oxygen therapy;
- Pneumothorax or drained pleurisy;
- Documented pulmonary embolism;
- Intracranial hypertension;
- ARDS refractory to inclusion, i.e.: i) oxygen partial pressure on inspired oxygen fraction a ratio (PaO2/FiO2) \<80 mm Hg or plateau pressure (Pplat) \> 32 cmH2O despite optimization of mechanical ventilation (tidal volume (Vt) set at 6 mL/kg weight predicted by height, FiO2 ≥80% and positive expiratory pressure (PEEP) ≥10 cmH2O) and despite the use of complementary therapies (including prone and/or inhaled nitric oxide); or ii) pH \<7. 25 with PaCO2 ≥60 mm Hg;
- ARDS evolving for more than 72 hours with intubation and mechanical ventilation;
- Patient deprived of liberty;
- Patient under legal protection (guardianship or curatorship);
- Known pregnancy or breast-feeding (a pregnancy test will be performed prior to inclusion in patients of childbearing age).
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
540 Patients enrolled
Trial Details
Trial ID
NCT06039215
Start Date
October 1 2023
End Date
August 1 2025
Last Update
September 15 2023
Active Locations (1)
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1
Assistance Publique-Hôpitaux de Paris service de santé publique
Créteil, Creteil, France, 94010