Description of Respiratory Mechanics in Patients With SARS-CoV-2 Associated ARDS

Evaluation of Respiratory Mechanics and Lung Recruitment in Patients With SARS-CoV-2 Associated Acute Respiratory Distress Syndrome

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.

Study Overview

• Status: Unknown
• Conditions: COVID; Acute Respiratory Distress Syndrome
• Intervention / Treatment: Other: PEEP trial

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).

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• France
  • Angers, France, 49100
    • Recruiting
    • CHU
    • Contact: Francois BELONCLE, MCU-PH; Phone Number: 0241345866; Email: Francois.Beloncle@chu-angers.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Mechanically Ventilated adult patients with COVID-19 Associated ARDS

Description

Inclusion Criteria:

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

Exclusion Criteria:

• pneumothorax

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment-to Inflation ratio (R/I ratio)	no unit	Day 1
Recruitment-to Inflation ratio (R/I ratio)	no unit	Day 5
Recruitment-to Inflation ratio (R/I ratio)	no unit	Day 10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PaO2/FiO2 (mmHg)	Arterial blood gases	Day 1
PaO2/FiO2 (mmHg)	Arterial blood gases	Day 5
PaO2/FiO2 (mmHg)	Arterial blood gases	Day 10
Lung volume recruited (VRec)	mL	Day 1
Lung volume recruited (VRec)	mL	Day 5
Lung volume recruited (VRec)	mL	Day 10
Plateau pressure (cm H2O)	Obtained by inspiratory pause of 5 seconds	Day 1
Plateau pressure (cm H2O)	Obtained by inspiratory pause of 5 seconds	Day 5
Plateau pressure (cm H2O)	Obtained by inspiratory pause of 5 seconds	Day 10
Oesophagal pressure (cm H2O)		Day 1
Oesophagal pressure (cm H2O)		Day 5
Oesophagal pressure (cm H2O)		Day 10
weight (Kg)		Day 1
weight (Kg)		Day 5
weight (Kg)		Day 10
urine output (mL)		day 1
urine output (mL)		day 5
urine output (mL)		day 10
serum creatinine (Umo/L)		day 1
serum creatinine (Umo/L)		day 5
serum creatinine (Umo/L)		day 10
Mean arterial pressure (mmHg)		day 1
Mean arterial pressure (mmHg)		day 5
Mean arterial pressure (mmHg)		day 10
Peak Pressure (cm H2O)		Day 1
Peak Pressure (cm H2O)		Day 5
Peak Pressure (cm H2O)		Day 10
PEEP total (cm H2O)	Obtained by expiratory pause of 5 seconds	Day 1
PEEP total (cm H2O)	Obtained by expiratory pause of 5 seconds	Day 5
PEEP total (cm H2O)	Obtained by expiratory pause of 5 seconds	Day 10
PEP Set (cm H2O)		Day 1
PEP Set (cm H2O)		Day 5
PEP Set (cm H2O)		Day 10
Height (cm)		Day 1
Airway pening pressure (cm H2O)		day 1
Airway pening pressure (cm H2O)		day 5
Airway pening pressure (cm H2O)		day 10
Expired volume in PEEP setted at 15 cmH2O (mL)	respiratory rate decreased to 10 /min, expired tidal volume displayed by the ventilator is noted	Day 1
Expired volume in PEEP setted at 15 cmH2O (mL)	respiratory rate decreased to 10 /min, expired tidal volume displayed by the ventilator is noted	Day 5
Expired volume in PEEP setted at 15 cmH2O (mL)	respiratory rate decreased to 10 /min, expired tidal volume displayed by the ventilator is noted	Day 10
Expired volume in PEEP setted at 5 cmH2O (mL)	respiratory rate decreased to 10 /min, expired tidal volume displayed by the ventilator is noted	Day 1
Expired volume in PEEP setted at 5 cmH2O (mL)	respiratory rate decreased to 10 /min, expired tidal volume displayed by the ventilator is noted	Day 5
Expired volume in PEEP setted at 5 cmH2O (mL)	respiratory rate decreased to 10 /min, expired tidal volume displayed by the ventilator is noted	Day 10

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Investigators: Principal Investigator: François BELONCLE, MCU PH, CHU Angers, Médecine intensive réanimation

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2020
• Primary Completion (Anticipated): April 20, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: April 9, 2020
• First Submitted That Met QC Criteria: April 14, 2020
• First Posted (Actual): April 17, 2020

Study Record Updates

• Last Update Posted (Actual): April 17, 2020
• Last Update Submitted That Met QC Criteria: April 14, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: COVID; Acute Respiratory Distress Syndrome; Respiratory mechanics; SARS CoV-2; Lung recruitability
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: 2030/31

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No