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Acute Respiratory Distress SyndromeNCT04350710

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

An observational study of Acute Respiratory Distress Syndrome and COVID, run by University Hospital, Angers at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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 . Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Respiratory Distress Syndrome, COVID
What is being tested?
PEEP trial
How many people
50 participants
Where
1 siteFrance
Study dates
18 Mar 2020to 31 Dec 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Mechanically Ventilated adult patients with COVID-19 Associated ARDS

Who may be able to join

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

Who cannot join

  • pneumothorax

Trial locations and contacts

1 site in 1 country.

François BELONCLE, MCU PH contact

0241345866

Francois.Beloncle@chu-angers.fr

France1 site, 1 recruiting

  • CHU

    Angers, 49100

    Francois BELONCLE, MCU-PH, 0241345866, Francois.Beloncle@chu-angers.fr

    Recruiting

Other trials in France

About this study

Official title: 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.

Read the 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).

Being tested
PEEP trial
Keywords
COVID, Acute Respiratory Distress Syndrome, SARS CoV-2, Lung recruitability, Respiratory mechanics
Medical subject headings
Respiratory Distress Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PEEP trialOther

    Measurement of Recruitment-to-Inflation Ratio

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment-to Inflation ratio (R/I ratio)

    no unit

    Measured: Day 1

  2. Recruitment-to Inflation ratio (R/I ratio)

    no unit

    Measured: Day 5

  3. Recruitment-to Inflation ratio (R/I ratio)

    no unit

    Measured: Day 10

Secondary outcomes (43)

  1. PaO2/FiO2 (mmHg)

    Arterial blood gases

    Measured: Day 1

  2. PaO2/FiO2 (mmHg)

    Arterial blood gases

    Measured: Day 5

  3. PaO2/FiO2 (mmHg)

    Arterial blood gases

    Measured: Day 10

  4. Lung volume recruited (VRec)

    mL

    Measured: Day 1

  5. Lung volume recruited (VRec)

    mL

    Measured: Day 5

  6. Lung volume recruited (VRec)

    mL

    Measured: Day 10

  7. Plateau pressure (cm H2O)

    Obtained by inspiratory pause of 5 seconds

    Measured: Day 1

  8. Plateau pressure (cm H2O)

    Obtained by inspiratory pause of 5 seconds

    Measured: Day 5

  9. Plateau pressure (cm H2O)

    Obtained by inspiratory pause of 5 seconds

    Measured: Day 10

  10. Oesophagal pressure (cm H2O)

    Measured: Day 1

  11. Oesophagal pressure (cm H2O)

    Measured: Day 5

  12. Oesophagal pressure (cm H2O)

    Measured: Day 10

  13. weight (Kg)

    Measured: Day 1

  14. weight (Kg)

    Measured: Day 5

  15. weight (Kg)

    Measured: Day 10

  16. urine output (mL)

    Measured: day 1

  17. urine output (mL)

    Measured: day 5

  18. urine output (mL)

    Measured: day 10

  19. serum creatinine (Umo/L)

    Measured: day 1

  20. serum creatinine (Umo/L)

    Measured: day 5

  21. serum creatinine (Umo/L)

    Measured: day 10

  22. Mean arterial pressure (mmHg)

    Measured: day 1

  23. Mean arterial pressure (mmHg)

    Measured: day 5

  24. Mean arterial pressure (mmHg)

    Measured: day 10

  25. Peak Pressure (cm H2O)

    Measured: Day 1

  26. Peak Pressure (cm H2O)

    Measured: Day 5

  27. Peak Pressure (cm H2O)

    Measured: Day 10

  28. PEEP total (cm H2O)

    Obtained by expiratory pause of 5 seconds

    Measured: Day 1

  29. PEEP total (cm H2O)

    Obtained by expiratory pause of 5 seconds

    Measured: Day 5

  30. PEEP total (cm H2O)

    Obtained by expiratory pause of 5 seconds

    Measured: Day 10

  31. PEP Set (cm H2O)

    Measured: Day 1

  32. PEP Set (cm H2O)

    Measured: Day 5

  33. PEP Set (cm H2O)

    Measured: Day 10

  34. Height (cm)

    Measured: Day 1

  35. Airway pening pressure (cm H2O)

    Measured: day 1

  36. Airway pening pressure (cm H2O)

    Measured: day 5

  37. Airway pening pressure (cm H2O)

    Measured: day 10

  38. Expired volume in PEEP setted at 15 cmH2O (mL)

    respiratory rate decreased to 10 /min, expired tidal volume displayed by the ventilator is noted

    Measured: Day 1

  39. Expired volume in PEEP setted at 15 cmH2O (mL)

    respiratory rate decreased to 10 /min, expired tidal volume displayed by the ventilator is noted

    Measured: Day 5

  40. Expired volume in PEEP setted at 15 cmH2O (mL)

    respiratory rate decreased to 10 /min, expired tidal volume displayed by the ventilator is noted

    Measured: Day 10

  41. Expired volume in PEEP setted at 5 cmH2O (mL)

    respiratory rate decreased to 10 /min, expired tidal volume displayed by the ventilator is noted

    Measured: Day 1

  42. Expired volume in PEEP setted at 5 cmH2O (mL)

    respiratory rate decreased to 10 /min, expired tidal volume displayed by the ventilator is noted

    Measured: Day 5

  43. Expired volume in PEEP setted at 5 cmH2O (mL)

    respiratory rate decreased to 10 /min, expired tidal volume displayed by the ventilator is noted

    Measured: Day 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2020
  2. Study start18 Mar 2020
  3. Primary completion20 Apr 2020 (estimated)
  4. Study completion31 Dec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04350710
Sponsor's protocol ID
2030/31
Status last verified
Apr 2020
First submitted
9 Apr 2020
Last updated
17 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Respiratory Distress Syndrome and COVID, run by University Hospital, Angers at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact François BELONCLE, MCU PH (0241345866, Francois.Beloncle@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment-to Inflation ratio (R/I ratio) (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04350710.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2020.

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