About this trial
Many patients admitted to the intensive care unit (ICU) for a severe lung disease called acute respiratory distress syndrome (ARDS) require mechanical ventilation and positive end-expiratory pressure (PEEP) to improve their oxygenation. Ventilator settings-and particularly the level of PEEP-are critical in the management of these patients. In fact, inappropriate ventilator settings can lead to a worsening of the patients' lung disease or compromise their hemodynamic status.
PEEP is a pressure maintained by the ventilator during the patient's exhalation to keep the alveoli open throughout the respiratory cycle. When PEEP is increased, if many alveoli open, this is called alveolar recruitment, which is the expected beneficial effect. However, in some patients, increasing PEEP can cause already-open alveoli to become overdistended without opening new alveoli; this is known as pulmonary overdistension. This phenomenon of overdistension will worsen the patient's pulmonary condition and may also lead to hemodynamic deterioration. To date, numerous techniques have been proposed for determining the optimal PEP level (alveolar recruitment without pulmonary overdistension) in these patients, but none can be recommended as the gold standard. The objective of our study is therefore to compare the various existing methods for determining the optimal PEEP level, in order to determine whether these methods are interchangeable and which would be the best method to use to optimize the care of these patients.
To this end, the investigators plan to conduct a prospective, observational, multicenter study in the Intensive Care Units of the Nice University Hospital and the European Hospital of Marseille. Patients on mechanical ventilation for ARDS will be included in the study, and medical and laboratory data from the electronic medical records obtained during the various PEEP measurements to determine the optimal PEEP will be analyzed.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients on invasive mechanical ventilation
Bilateral findings on chest X-ray
PaO₂/FiO₂ ratio <200 with PEEP ≥+5 cmH₂O
No evidence of cardiogenic pulmonary overload
Disqualifiers
Individuals receiving enhanced protection, namely minors
Individuals deprived of their liberty by a judicial or administrative decision
Pregnant and breastfeeding women
Individuals residing in a health or social care facility
Trial design
Single group
Treatments tested in this trial
Ventilation at different levels of PEP including a test involving a gradual decrease in PEP.
Dietary supplementInitial PEEP level will be set according to the PEEP/FiO2 table. The PEEP level will then be adjusted to achieve a plateau pressure of 28-30 cmH₂O. After 10 minutes, various hemodynamic and respiratory variables will be recorded, and an arterial blood gas analysis will be performed to assess the patient's respiratory mechanics and oxygenation. Next, the airway opening pressure will be measured, and the patient's recruitment potential will be assessed by calculating the R/I ratio through a sudden reduction in PEP from 15 cmH₂O to 5 cmH₂O over a single respiratory cycle. Following this, PEEP will be raised back to the initial level for at least 5 minutes and then gradually reduced in 2 cmH₂O increments every 2 minutes until reaching the AOP level or a PEEP level of 5 cmH₂O. In total, the optimal PEP level will be determined using six different techniques, allowing the clinician to obtain six optimal PEP values and thus best customize the ventilator settings for each patient.
Treatment groups
Trial outcomes
Primary outcomes
Level of positive end expiratory pressure
The primary outcome measure will be the optimal level of positive end expiratory pressure achieved with each of the methods used. The measurement of differents optimal level of positive end expiratory pressure will be determined after the positive end expiratory pressure reduction procedure.
Secondary outcomes
Minimale driving pressure
Minimale driving pressure will be assessed at various optimal positive end expiratory pressure levels according with each of the methods used. Determining the minimum driving pressure of differents optimal level of positive end expiratory pressure will be determined after the positive end expiratory pressure reduction procedure
Maximum pulmonary compliance
Maximum pulmonary compliance will be assessed at various optimal positive end expiratory pressure levels according with each of the methods used. Determining the maximum pulmonary compliance of differents optimal level of positive end expiratory pressure will be determined after the positive end expiratory pressure reduction procedure
Sponsors and contacts
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