Clinical trial NCT04350710: Description of Respiratory Mechanics in Patients With SARS-CoV-2 Associated ARDS
Official title: Evaluation of Respiratory Mechanics and Lung Recruitment in Patients With SARS-CoV-2 Associated Acute Respiratory Distress Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Respiratory Distress Syndrome
COVID
Keywords: COVID
Acute Respiratory Distress Syndrome
SARS CoV-2
Lung recruitability
Respiratory mechanics
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2020-04-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Mechanically Ventilated adult patients with COVID-19 Associated ARDS

Brief summary: The aim of this observationnal study is to describe respiratory mechanics and lung recruitement in patients with SARS-CoV-2 Associated Acute Respiratory Distress Syndrome who underwent invasive ventilation on endotracheal tube, admitted to the medical ICU of Angers university hospital . Statics measurements of respiratory system compliance were performed at 2 differents levels of PEEP (15 cmH2O and 5 cmH2O). The recruited volume is computed as the difference between the volume expired from PEEP 15 to 5 cmH2O and the volume predicted by compliance at PEEP 5 cmH2O . The recruitment-to-Inflation (R/I) ratio (i.e. the ratio between the recruited lung compliance and CRS at PEEP 5 cmH2O) is used to assess lung recruitability. A R/I ratio value higher than or equal to 0.5 was used to define highly recruiter patients.

Detailed description: The investigators perform an observational prospective study in patients admitted to medical ICU in Angers University hospital with a confirmed COVID 19 pneumonia and who require invasive ventilation on endotracheal tube. Participants receive initially deep sedation and neuromuscular blockers for 24 hours and are ventilated in volume-controlled mode with a tidal volume of 6 mL/kg of predicted body weight, a constant inspiratory flow of 60 L/minute and a respiratory rate adjusted to maintain pH above 7.35 when possible. A PEEP decremental trial from 15 to 5 cmH2O was performed (15 minutes by step).

Esophageal pressure monitoring and electrical impedance tomography (EIT) are collected if available. Arterial blood gases and respiratory mechanics are measured at the end of each step.

The recruitment-to-Inflation (R/I) ratio (i.e. the ratio between the recruited lung compliance and CRS at PEEP 5 cmH2O) is used to assess lung recruitability. A R/I ratio value higher than or equal to 0.5 is used to define highly recruiter patients.

By the end of the recording time, a low-flow (5 L/min) inflation from PEEP 5 cmH2O (tidal volume = 6ml/kg PBW) is then performed after a prolonged expiration to identify a potential airway closure and the corresponding airway opening pressure (AOP).

Investigators perform these measurements at day 1, day 5 and day 10 from ICU admission if participants still require controlled ventilation.

The investigators also collect clinical data about each participant (past medical history, ICU discharge, hospital discharge, date of death, ventilator acquired pneumonia, thromboembolic event, use of NO, use of ECMO or renal replacement therapy).

Eligibility criteria: Inclusion Criteria:

* ARDS criteria according to Berlin classification criteria
* Invasive mechanical ventilation on endotracheal tube
* SARS Cov-2 infection

Exclusion Criteria:

* pneumothorax

Primary outcomes:
measure: Recruitment-to Inflation ratio (R/I ratio)
timeFrame: Day 1
measure: Recruitment-to Inflation ratio (R/I ratio)
timeFrame: Day 5
measure: Recruitment-to Inflation ratio (R/I ratio)
timeFrame: Day 10
Secondary outcomes:
measure: PaO2/FiO2 (mmHg)
timeFrame: Day 1
measure: PaO2/FiO2 (mmHg)
timeFrame: Day 5
measure: PaO2/FiO2 (mmHg)
timeFrame: Day 10
measure: Lung volume recruited (VRec)
timeFrame: Day 1
measure: Lung volume recruited (VRec)
timeFrame: Day 5
measure: Lung volume recruited (VRec)
timeFrame: Day 10
measure: Plateau pressure (cm H2O)
timeFrame: Day 1
measure: Plateau pressure (cm H2O)
timeFrame: Day 5
measure: Plateau pressure (cm H2O)
timeFrame: Day 10
measure: Oesophagal pressure (cm H2O)
timeFrame: Day 1
measure: Oesophagal pressure (cm H2O)
timeFrame: Day 5
measure: Oesophagal pressure (cm H2O)
timeFrame: Day 10
measure: weight (Kg)
timeFrame: Day 1
measure: weight (Kg)
timeFrame: Day 5
measure: weight (Kg)
timeFrame: Day 10
measure: urine output (mL)
timeFrame: day 1
measure: urine output (mL)
timeFrame: day 5
measure: urine output (mL)
timeFrame: day 10
measure: serum creatinine (Umo/L)
timeFrame: day 1
measure: serum creatinine (Umo/L)
timeFrame: day 5
measure: serum creatinine (Umo/L)
timeFrame: day 10
measure: Mean arterial pressure (mmHg)
timeFrame: day 1
measure: Mean arterial pressure (mmHg)
timeFrame: day 5
measure: Mean arterial pressure (mmHg)
timeFrame: day 10
measure: Peak Pressure (cm H2O)
timeFrame: Day 1
measure: Peak Pressure (cm H2O)
timeFrame: Day 5
measure: Peak Pressure (cm H2O)
timeFrame: Day 10
measure: PEEP total (cm H2O)
timeFrame: Day 1
measure: PEEP total (cm H2O)
timeFrame: Day 5
measure: PEEP total (cm H2O)
timeFrame: Day 10
measure: PEP Set (cm H2O)
timeFrame: Day 1
measure: PEP Set (cm H2O)
timeFrame: Day 5
measure: PEP Set (cm H2O)
timeFrame: Day 10
measure: Height (cm)
timeFrame: Day 1
measure: Airway pening pressure (cm H2O)
timeFrame: day 1
measure: Airway pening pressure (cm H2O)
timeFrame: day 5
measure: Airway pening pressure (cm H2O)
timeFrame: day 10
measure: Expired volume in PEEP setted at 15 cmH2O (mL)
timeFrame: Day 1
measure: Expired volume in PEEP setted at 15 cmH2O (mL)
timeFrame: Day 5
measure: Expired volume in PEEP setted at 15 cmH2O (mL)
timeFrame: Day 10
measure: Expired volume in PEEP setted at 5 cmH2O (mL)
timeFrame: Day 1
measure: Expired volume in PEEP setted at 5 cmH2O (mL)
timeFrame: Day 5
measure: Expired volume in PEEP setted at 5 cmH2O (mL)
timeFrame: Day 10
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU
Study officials:
affiliation: CHU Angers, Médecine intensive réanimation
name: François BELONCLE, MCU PH
role: PRINCIPAL_INVESTIGATOR
References: