V/Q Matching Variations With PEEP in ARDS According to Compliance-based Phenotypes (France)
ConditionARDS
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Angers
About this trial
This study aim to compare the effect of Positive End Expiratory Pressure (PEEP) on ventilation/perfusion mismatch in two phenotypes of patients with moderate-to-severe Acute Respiratory Distress Syndrome (ARDS), characterized by their respiratory system elastance (Ers). Ventilation/perfusion mismatch will be assessed by Electrical Impedance Tomography (EIT).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
intubated patients with moderate and severe ARDS (Berlin definition, PaO2/FiO2 ≤200 mmHg at PEEP 5 cmH2O)
undergoing deep sedation
on controlled mechanical ventilation
between 24 hours and 5 days after intubation.
Disqualifiers
age <18 years old; pregnancy
patient undergoing legal protection
contra-indications to EIT (e. g. severe chest trauma or wounds)
pneumothorax; patient undergoing ECMO
Trial design
Design model
Parallel
Treatments tested in this trial
PEEP increase
Procedure/SurgeryPositive End Expiratory Pressure (PEEP) will be increased from 5 to 15 cmH2O.
PEEP decrease
Procedure/SurgeryPositive End Expiratory Pressure (PEEP) will be decreased from 15 to 5 cmH2O.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Strategy A: PEEP 15 cmH2O → PEEP 5 cmH2OExperimental treatment 1 intervention
Group B: Strategy B: PEEP 5 cmH2O → PEEP 15 cmH2OActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Difference in ventilation/perfusion mismatch between PEEP 5 and 15 cmH2O according to the two studied phenotypes
Ventilation/perfusion (V/Q) mismatch will be assessed by Electrical Impedance Tomography (EIT). Mismatch is expressed in %. Comparison between phenotype with higher and lower elastance will be performed.
Time frame
immediately after each interventionSecondary outcomes
1
Difference in respiratory mechanics between PEEP 5 and 15 cmH2O according to the two studied phenotypes
Plateau pressure and total PEEP will be aggregated to compute driving pressure (Plateau pressure minus total PEEP, all in cmH2O). Respiratory system compliance will be computed by dividing tidal volume by driving pressure (in mL.cmH2O-1; respiratory system resistance will be computed as the inverse of compliance; all these values will be assessed and compared between the two PEEP levels. Comparison between phenotype with higher and lower elastance will be performed.
Time frame
immediately after each intervention2
Difference in oxygenation between PEEP 5 and 15 cmH2O according to the two studied phenotypes
PaO2 (in mmHg) will be assessed and compared between the two PEEP levels. Comparison between phenotype with higher and lower elastance will be performed.
Time frame
immediately after each intervention3
Difference in carbon clearance between PEEP 5 and 15 cmH2O according to the two studied phenotypes
PaCO2 (in mmHg) will be assessed and compared between the two PEEP levels. Ventilatory ratio (no unit) will be derived from the PaCO2 values. Comparison between phenotype with higher and lower elastance will be performed.
Time frame
immediately after each intervention4
Difference in dead space measured by capnometric volumetry between PEEP 5 and 15 cmH2O according to the two studied phenotypes
VCO2 (measured by Vcap, in mmHg) will be assessed and compared between the two PEEP levels. Comparison between phenotype with higher and lower elastance will be performed.
Time frame
immediately after each interventionSponsors and contacts
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Source ClinicalTrials.gov