Clinical trial NCT04381286: Transpulmonary Driving Pressure in ARDS COVID19 Patients
Official title: Transpulmonary Driving Pressure in ARDS COVID19 Patients / TRANSPULMONARY-COVID19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mechanical Ventilation
SARS-CoV-2
COVID-19
Keywords: elastance
Acute respiratory distress syndrome
Esophageal pressure
Pleural pressure
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-05-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with SARS-CoV-2 and mechanical ventilation requirement

Brief summary: A majority (65-85%) of critically ill patients admitted in intensive care units with a confirmed diagnostic of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) developed an acute respiratory distress syndrome (ARDS) according to BERLIN criteria. Gattinoni et al. recently described that the ARDS related to SARS-CoV-2 was not a "Typical" ARDS. Patients affected by this infection present indeed a major hypoxemia, which was surprisingly associated in early phase with a high compliance of respiratory system, more than 50 ml/cm H2O in most cases. The cornerstone of current treatment in case of ARDS is the use of "lung protective" ventilation, including limited tidal volumes (VT), low end-inspiratory plateau pressures while maintaining sufficiently-high positive end-expiratory pressures (PEEP). However, high levels of PEEP in patients may have detrimental effects on hemodynamic status and fluid retention, particularly when the respiratory system compliance is normal. High PEEP may also lead to overdistension and an increase of alveolar dead space. The airway pressures commonly monitored does not reliably reflect the impact of pressures on the lung parenchyma. Elastance of chest wall may indeed largely influence values of airways pressions. In contrast, transpulmonary pressure obtained using esophageal pressure (Pes) directly reflect lung overdistension risk and lung properties. In order to better understand this new kind of ARDS characterized by modest recruitable profile and to better personalize mechanical ventilation setting and therapy it is obvious to precise transpulmonary pressure.


Eligibility criteria: Inclusion criteria:

* Major patients (18-90 years old)
* Hospitalized following SARS-CoV-2
* Mechanical ventilatory support

Exclusion criteria:

* Minor patients

Primary outcomes:
measure: Duration of mechanical Ventilation
timeFrame: 1 day
Secondary outcomes:
measure: Number of Participants with during of Acute respiratory distress syndrom (SDRA)
timeFrame: 1 day
measure: Length of stay in intensive care unit
timeFrame: 1 day
measure: Mortality
timeFrame: 1 day
measure: number of patients with pulmonary complications
timeFrame: 1 day
measure: Number of Participants with pulmonary stress and strain
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Ramin Séverin, MD
role: PRINCIPAL_INVESTIGATOR
References: