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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

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.

Condition or disease Intervention/treatment
Acute Respiratory Distress Syndrome COVID 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).

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Respiratory Mechanics and Lung Recruitment in Patients With SARS-CoV-2 Associated Acute Respiratory Distress Syndrome
Actual Study Start Date : March 18, 2020
Estimated Primary Completion Date : April 20, 2020
Estimated Study Completion Date : December 31, 2020



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


Primary Outcome Measures :
  1. Recruitment-to Inflation ratio (R/I ratio) [ Time Frame: Day 1 ]
    no unit

  2. Recruitment-to Inflation ratio (R/I ratio) [ Time Frame: Day 5 ]
    no unit

  3. Recruitment-to Inflation ratio (R/I ratio) [ Time Frame: Day 10 ]
    no unit


Secondary Outcome Measures :
  1. PaO2/FiO2 (mmHg) [ Time Frame: Day 1 ]
    Arterial blood gases

  2. PaO2/FiO2 (mmHg) [ Time Frame: Day 5 ]
    Arterial blood gases

  3. PaO2/FiO2 (mmHg) [ Time Frame: Day 10 ]
    Arterial blood gases

  4. Lung volume recruited (VRec) [ Time Frame: Day 1 ]
    mL

  5. Lung volume recruited (VRec) [ Time Frame: Day 5 ]
    mL

  6. Lung volume recruited (VRec) [ Time Frame: Day 10 ]
    mL

  7. Plateau pressure (cm H2O) [ Time Frame: Day 1 ]
    Obtained by inspiratory pause of 5 seconds

  8. Plateau pressure (cm H2O) [ Time Frame: Day 5 ]
    Obtained by inspiratory pause of 5 seconds

  9. Plateau pressure (cm H2O) [ Time Frame: Day 10 ]
    Obtained by inspiratory pause of 5 seconds

  10. Oesophagal pressure (cm H2O) [ Time Frame: Day 1 ]
  11. Oesophagal pressure (cm H2O) [ Time Frame: Day 5 ]
  12. Oesophagal pressure (cm H2O) [ Time Frame: Day 10 ]
  13. weight (Kg) [ Time Frame: Day 1 ]
  14. weight (Kg) [ Time Frame: Day 5 ]
  15. weight (Kg) [ Time Frame: Day 10 ]
  16. urine output (mL) [ Time Frame: day 1 ]
  17. urine output (mL) [ Time Frame: day 5 ]
  18. urine output (mL) [ Time Frame: day 10 ]
  19. serum creatinine (Umo/L) [ Time Frame: day 1 ]
  20. serum creatinine (Umo/L) [ Time Frame: day 5 ]
  21. serum creatinine (Umo/L) [ Time Frame: day 10 ]
  22. Mean arterial pressure (mmHg) [ Time Frame: day 1 ]
  23. Mean arterial pressure (mmHg) [ Time Frame: day 5 ]
  24. Mean arterial pressure (mmHg) [ Time Frame: day 10 ]
  25. Peak Pressure (cm H2O) [ Time Frame: Day 1 ]
  26. Peak Pressure (cm H2O) [ Time Frame: Day 5 ]
  27. Peak Pressure (cm H2O) [ Time Frame: Day 10 ]
  28. PEEP total (cm H2O) [ Time Frame: Day 1 ]
    Obtained by expiratory pause of 5 seconds

  29. PEEP total (cm H2O) [ Time Frame: Day 5 ]
    Obtained by expiratory pause of 5 seconds

  30. PEEP total (cm H2O) [ Time Frame: Day 10 ]
    Obtained by expiratory pause of 5 seconds

  31. PEP Set (cm H2O) [ Time Frame: Day 1 ]
  32. PEP Set (cm H2O) [ Time Frame: Day 5 ]
  33. PEP Set (cm H2O) [ Time Frame: Day 10 ]
  34. Height (cm) [ Time Frame: Day 1 ]
  35. Airway pening pressure (cm H2O) [ Time Frame: day 1 ]
  36. Airway pening pressure (cm H2O) [ Time Frame: day 5 ]
  37. Airway pening pressure (cm H2O) [ Time Frame: day 10 ]
  38. 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

  39. 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

  40. 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

  41. 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

  42. 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

  43. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Mechanically Ventilated adult patients with COVID-19 Associated ARDS
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • pneumothorax

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04350710


Contacts
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Contact: François BELONCLE, MCU PH 0241345866 Francois.Beloncle@chu-angers.fr

Locations
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France
CHU Recruiting
Angers, France, 49100
Contact: Francois BELONCLE, MCU-PH    0241345866    Francois.Beloncle@chu-angers.fr   
Sponsors and Collaborators
University Hospital, Angers
Investigators
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Principal Investigator: François BELONCLE, MCU PH CHU Angers, Médecine intensive réanimation
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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT04350710    
Other Study ID Numbers: 2030/31
First Posted: April 17, 2020    Key Record Dates
Last Update Posted: April 17, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Angers:
COVID
Acute Respiratory Distress Syndrome
SARS CoV-2
Lung recruitability
Respiratory mechanics
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury