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

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ClinicalTrials.gov Identifier: NCT04350710
Recruitment Status : Recruiting
First Posted : April 17, 2020
Last Update Posted : April 17, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

Tracking Information
First Submitted Date April 9, 2020
First Posted Date April 17, 2020
Last Update Posted Date April 17, 2020
Actual Study Start Date March 18, 2020
Estimated Primary Completion Date April 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 14, 2020)
  • Recruitment-to Inflation ratio (R/I ratio) [ Time Frame: Day 1 ]
    no unit
  • Recruitment-to Inflation ratio (R/I ratio) [ Time Frame: Day 5 ]
    no unit
  • Recruitment-to Inflation ratio (R/I ratio) [ Time Frame: Day 10 ]
    no unit
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: April 14, 2020)
  • PaO2/FiO2 (mmHg) [ Time Frame: Day 1 ]
    Arterial blood gases
  • PaO2/FiO2 (mmHg) [ Time Frame: Day 5 ]
    Arterial blood gases
  • PaO2/FiO2 (mmHg) [ Time Frame: Day 10 ]
    Arterial blood gases
  • Lung volume recruited (VRec) [ Time Frame: Day 1 ]
    mL
  • Lung volume recruited (VRec) [ Time Frame: Day 5 ]
    mL
  • Lung volume recruited (VRec) [ Time Frame: Day 10 ]
    mL
  • Plateau pressure (cm H2O) [ Time Frame: Day 1 ]
    Obtained by inspiratory pause of 5 seconds
  • Plateau pressure (cm H2O) [ Time Frame: Day 5 ]
    Obtained by inspiratory pause of 5 seconds
  • Plateau pressure (cm H2O) [ Time Frame: Day 10 ]
    Obtained by inspiratory pause of 5 seconds
  • Oesophagal pressure (cm H2O) [ Time Frame: Day 1 ]
  • Oesophagal pressure (cm H2O) [ Time Frame: Day 5 ]
  • Oesophagal pressure (cm H2O) [ Time Frame: Day 10 ]
  • weight (Kg) [ Time Frame: Day 1 ]
  • weight (Kg) [ Time Frame: Day 5 ]
  • weight (Kg) [ Time Frame: Day 10 ]
  • urine output (mL) [ Time Frame: day 1 ]
  • urine output (mL) [ Time Frame: day 5 ]
  • urine output (mL) [ Time Frame: day 10 ]
  • serum creatinine (Umo/L) [ Time Frame: day 1 ]
  • serum creatinine (Umo/L) [ Time Frame: day 5 ]
  • serum creatinine (Umo/L) [ Time Frame: day 10 ]
  • Mean arterial pressure (mmHg) [ Time Frame: day 1 ]
  • Mean arterial pressure (mmHg) [ Time Frame: day 5 ]
  • Mean arterial pressure (mmHg) [ Time Frame: day 10 ]
  • Peak Pressure (cm H2O) [ Time Frame: Day 1 ]
  • Peak Pressure (cm H2O) [ Time Frame: Day 5 ]
  • Peak Pressure (cm H2O) [ Time Frame: Day 10 ]
  • PEEP total (cm H2O) [ Time Frame: Day 1 ]
    Obtained by expiratory pause of 5 seconds
  • PEEP total (cm H2O) [ Time Frame: Day 5 ]
    Obtained by expiratory pause of 5 seconds
  • PEEP total (cm H2O) [ Time Frame: Day 10 ]
    Obtained by expiratory pause of 5 seconds
  • PEP Set (cm H2O) [ Time Frame: Day 1 ]
  • PEP Set (cm H2O) [ Time Frame: Day 5 ]
  • PEP Set (cm H2O) [ Time Frame: Day 10 ]
  • Height (cm) [ Time Frame: Day 1 ]
  • Airway pening pressure (cm H2O) [ Time Frame: day 1 ]
  • Airway pening pressure (cm H2O) [ Time Frame: day 5 ]
  • Airway pening pressure (cm H2O) [ Time Frame: day 10 ]
  • Expired volume in PEEP setted at 15 cmH2O (mL) [ Time Frame: Day 1 ]
    respiratory rate decreased to 10 /min, expired tidal volume displayed by the ventilator is noted
  • Expired volume in PEEP setted at 15 cmH2O (mL) [ Time Frame: Day 5 ]
    respiratory rate decreased to 10 /min, expired tidal volume displayed by the ventilator is noted
  • Expired volume in PEEP setted at 15 cmH2O (mL) [ Time Frame: Day 10 ]
    respiratory rate decreased to 10 /min, expired tidal volume displayed by the ventilator is noted
  • Expired volume in PEEP setted at 5 cmH2O (mL) [ Time Frame: Day 1 ]
    respiratory rate decreased to 10 /min, expired tidal volume displayed by the ventilator is noted
  • Expired volume in PEEP setted at 5 cmH2O (mL) [ Time Frame: Day 5 ]
    respiratory rate decreased to 10 /min, expired tidal volume displayed by the ventilator is noted
  • Expired volume in PEEP setted at 5 cmH2O (mL) [ Time Frame: Day 10 ]
    respiratory rate decreased to 10 /min, expired tidal volume displayed by the ventilator is noted
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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).

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Mechanically Ventilated adult patients with COVID-19 Associated ARDS
Condition
  • Acute Respiratory Distress Syndrome
  • COVID
Intervention Other: PEEP trial
Measurement of Recruitment-to-Inflation Ratio
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 14, 2020)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2020
Estimated Primary Completion Date April 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • pneumothorax
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: François BELONCLE, MCU PH 0241345866 Francois.Beloncle@chu-angers.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04350710
Other Study ID Numbers 2030/31
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University Hospital, Angers
Study Sponsor University Hospital, Angers
Collaborators Not Provided
Investigators
Principal Investigator: François BELONCLE, MCU PH CHU Angers, Médecine intensive réanimation
PRS Account University Hospital, Angers
Verification Date April 2020