Surfactant replacement therapy (SRT) improves oxygenation and survival in NRDS and some infant ARDS. SRT was tried in adult ARDS with conflicting results. Research by Filoche and Grotberg helped to understand the failure of previous clinical trials and yielded a strong scientific rationale for SRT success, now allowing to design a new administration protocol for SRT in adults, to be tested by this clinical trial in COVID-19 adult ARDS patients. Patients will be randomized to receive either a bronchial fibroscopy alone (with aspiration of secretions) or a bronchial fibroscopy with administration of 3 mL/kg of a solution of poractant alpha diluted to 16 mg/mL and distributed into each of the 5 lobar bronchi.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
20
Patient receiving surfactant (3 mL/kg of a poractant alpha solution diluted to 16 mg/mL, resulting in a total dose of 48mg/kg) administred by bronchial fibroscopy. The total volume will be divided in each of the five lobar bronchi.
CH Francois Quesnay
Mantes-la-Jolie, France
RECRUITINGEvolution of the PaO2 / FiO2 ratio between the measurements taken before (t0) and one hour after the end of the invasive procedure (H1).
Time frame: 1 hour post treatment
Oxygenation : PaO2 / FiO2 ratio.
Time frame: up to Day 1 and up to Day 7
Oxygenation : area under the PaO2 / FiO2 curve.
Time frame: up to Day 1 and up to Day 7
Oxygenation : area under the SpO2 curve.
Time frame: up to Hour 1 and up to Hour 24
Evolution of thoraco-pulmonary compliance (mL / mbar) between before and one hour after the procedure.
Time frame: 1 hour
Overall survival rate
Time frame: at 28 days, 56 days.
Mortality rate at discharge from the intensive care unit.
Time frame: through study completion, an average of 6 months.
Mortality rate at discharge from the hospital.
Time frame: through study completion, an average of 6 months.
Number of ventilator-free days
Time frame: Day 28, Day 56
Number of prone position sessions.
Time frame: up to 56 days
Time between inclusion and the last prone position session.
Time frame: up to 56 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.