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

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04350710
• Other study ID #: 2030/31
• Status: Recruiting
• Start date: March 18, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2020
• Source: University Hospital, Angers
• Contact: François BELONCLE, MCU PH
• Phone: 0241345866
• Email: Francois.Beloncle[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2020
• Est. primary completion date: April 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ARDS criteria according to Berlin classification criteria

• Invasive mechanical ventilation on endotracheal tube

• SARS Cov-2 infection

Exclusion Criteria:

• pneumothorax

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• COVID
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Other:
• PEEP trial
Measurement of Recruitment-to-Inflation Ratio

Locations

Country	Name	City	State
France	CHU	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment-to Inflation ratio (R/I ratio)	no unit	Day 1
Primary	Recruitment-to Inflation ratio (R/I ratio)	no unit	Day 5
Primary	Recruitment-to Inflation ratio (R/I ratio)	no unit	Day 10
Secondary	PaO2/FiO2 (mmHg)	Arterial blood gases	Day 1
Secondary	PaO2/FiO2 (mmHg)	Arterial blood gases	Day 5
Secondary	PaO2/FiO2 (mmHg)	Arterial blood gases	Day 10
Secondary	Lung volume recruited (VRec)	mL	Day 1
Secondary	Lung volume recruited (VRec)	mL	Day 5
Secondary	Lung volume recruited (VRec)	mL	Day 10
Secondary	Plateau pressure (cm H2O)	Obtained by inspiratory pause of 5 seconds	Day 1
Secondary	Plateau pressure (cm H2O)	Obtained by inspiratory pause of 5 seconds	Day 5
Secondary	Plateau pressure (cm H2O)	Obtained by inspiratory pause of 5 seconds	Day 10
Secondary	Oesophagal pressure (cm H2O)		Day 1
Secondary	Oesophagal pressure (cm H2O)		Day 5
Secondary	Oesophagal pressure (cm H2O)		Day 10
Secondary	weight (Kg)		Day 1
Secondary	weight (Kg)		Day 5
Secondary	weight (Kg)		Day 10
Secondary	urine output (mL)		day 1
Secondary	urine output (mL)		day 5
Secondary	urine output (mL)		day 10
Secondary	serum creatinine (Umo/L)		day 1
Secondary	serum creatinine (Umo/L)		day 5
Secondary	serum creatinine (Umo/L)		day 10
Secondary	Mean arterial pressure (mmHg)		day 1
Secondary	Mean arterial pressure (mmHg)		day 5
Secondary	Mean arterial pressure (mmHg)		day 10
Secondary	Peak Pressure (cm H2O)		Day 1
Secondary	Peak Pressure (cm H2O)		Day 5
Secondary	Peak Pressure (cm H2O)		Day 10
Secondary	PEEP total (cm H2O)	Obtained by expiratory pause of 5 seconds	Day 1
Secondary	PEEP total (cm H2O)	Obtained by expiratory pause of 5 seconds	Day 5
Secondary	PEEP total (cm H2O)	Obtained by expiratory pause of 5 seconds	Day 10
Secondary	PEP Set (cm H2O)		Day 1
Secondary	PEP Set (cm H2O)		Day 5
Secondary	PEP Set (cm H2O)		Day 10
Secondary	Height (cm)		Day 1
Secondary	Airway pening pressure (cm H2O)		day 1
Secondary	Airway pening pressure (cm H2O)		day 5
Secondary	Airway pening pressure (cm H2O)		day 10
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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