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AzTrials

SARS PneumoniaCOVID-VENTNCT04445961

Respiratory Mechanics and Gas Exchange in Patients With COVID-19 and Hypoxemic Acute Respiratory Failure

An observational study of SARS Pneumonia, run by I.M. Sechenov First Moscow State Medical University at 3 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Data on respiratory mechanics and gas exchange in acute respiratory failure in COVID-19 patients is limited. Knowledge of respiratory mechanics and gas exchange in COVID-19 can lead to different selection of mechanical ventilation strategy, reduce ventilator-associated lung injury and improve outcomes. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
SARS Pneumonia
What is being tested?
Respiratory mechanics measurement and Gas exchange measurement
How many people
117 participants
Where
3 sitesRussia
Study dates
1 May 2020to 14 Aug 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 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All patients with COVID-19 requiring respiratory support

Who may be able to join

  • all patients with COVID-19 and acute respiratory failure on invasive and noninvasive ventilation

Who cannot join

  • Patients who reached the following goals at conventional oxygen therapy (oxygen flow < 15 l/min): peripheral capillary oxygen saturation(SpO2) > 93%, no visible work of auxiliary respiratory muscles, no fatigue, stable hemodynamics (no need in any catecholamines and/or life-threatening heart rhythm abnormalities),
  • less than 24 ours in intensive care unit (ICU) by any reason,
  • lung emphysema,
  • primary lung diseases (chronic obstructive lung disease-COPD, interstitial lung diseases, etc) or tumour metastases in lungs,
  • chronic decompensated diseases with extrapulmonary organ dysfunction (tumour progression, liver cirrhosis, congestive heart failure),
  • atonic coma.

Trial locations and contacts

3 sites in 1 country.

Russia3 sites

  • Sechenov University Clinic #1

    Moscow

  • Sechenov University Clinic #3

    Moscow

  • Sechenov University Clinic #4

    Moscow

Other trials in Russia

About this study

Official title: Respiratory Mechanics and Gas Exchange in Patients With COVID-19 and Hypoxemic Acute Respiratory Failure: Multicentral Observational Study

Data on respiratory mechanics and gas exchange in acute respiratory failure in COVID-19 patients is limited. Knowledge of respiratory mechanics and gas exchange in COVID-19 can lead to different selection of mechanical ventilation strategy, reduce ventilator-associated lung injury and improve outcomes. The objective of the study is to evaluate the respiratory mechanics, lung recruitability and gas exchange in COVID-19 -associated acute respiratory failure during the whole course of mechanical ventilation - invasive or non-invasive.

Read the detailed description

In December 2019, an outbreak of a novel coronavirus (SARS-CoV-2) emerged in Wuhan, China and rapidly spread worldwide. The World Health Organization (WHO) declared the outbreak a pandemic on March 11th, 2020. The clinical disease (COVID-19) results in critical illness in about 5% of patients with predominant acute respiratory failure.

The goal of the study is the evaluation of the respiratory mechanics (peak inspiratory pressure (PIP), plateau pressure (Pplat), static compliance (Cstat), driving pressure (DP) at different positive end-expiratory pressure (PEEP) levels and different tidal volumes (Vt) (6-8 ml/kg ideal body weight), lung recruitability (by change of DP and oxygenation) and gas exchange (PaO2/FiO2 ratio and alveolar dead space) in COVID-19 -associated acute respiratory failure during the whole course of mechanical ventilation - invasive or non-invasive for selection of safe and effective PEEP level, Vt, respiratory rate (RR) and inspiratory oxygen fraction (FiO2) during the whole course of mechanical ventilation - invasive or non-invasive.

This study is multicentral observational trial in 3 University clinics.

Conditions
SARS Pneumonia
Being tested
Respiratory mechanics measurement, Gas exchange measurement
Keywords
SARS Pneumonia, ARDS, COVID-19, compliance, recruitability
Medical subject headings
COVID-19, Patient Compliance

What participants receive

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

  • Respiratory mechanics measurementDiagnostic test

    Measurement of peak inspiratory pressure, plateau pressure, calculation of static compliance and driving pressure

  • Gas exchange measurementDiagnostic test

    Measurement of arterial oxygen and tension and arterial dioxide tension, calculation of arterial partial oxygen tension to inspiratory oxygen fraction (PaO2/FiO2) ratio and alveolar dead space

What is being measured

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

  1. Optimum positive end-expiratory pressure (PEEP) level

    Positive end-expiratory pressure (PEEP) selection at minimum level with maximum static compliance and the highest peripheral capillary oxygen saturation over fraction of inspired oxygen (SpO2/FiO2)

    Measured: On day 1 during mechanical ventilation

  2. Optimum positive end-expiratory pressure (PEEP) level

    Positive end-expiratory pressure (PEEP) selection at minimum level with maximum static compliance and the highest peripheral capillary oxygen saturation over fraction of inspired oxygen (SpO2/FiO2)

    Measured: On day 7 during mechanical ventilation

  3. Number of patients with recruitable lung

    Peripheral capillary oxygen saturation (SpO2) change from 90% after recruitment maneuver (doubled tidal volume for 15 respiratory cycles) - if peripheral capillary oxygen saturation (SpO2) after recruitment maneuver more than 95%-recruitable

    Measured: On day 1 during mechanical ventilation

  4. Number of patients with recruitable lung

    Peripheral capillary oxygen saturation (SpO2) change from 90% after recruitment maneuver (doubled tidal volume for 15 respiratory cycles) - if peripheral capillary oxygen saturation (SpO2) after recruitment maneuver more than 95%-recruitable

    Measured: On day 7 during mechanical ventilation

Secondary outcomes (5)

  1. Change in alveolar dead space

    Calculation of the alveolar dead space using end-tidal carbon dioxide measurement and arterial carbon dioxide tension measurement

    Measured: On day 1, 3, 5, 7, 10, 14, 21 during mechanical ventilation

  2. Change in plethysmogram variability during recruitment maneuver

    Measurement of plethysmogram variability before and during recruitment maneuver

    Measured: On day 1, 3, 5, 7, 10, 14, 21 during mechanical ventilation

  3. Change in arterial partial oxygen tension to inspiratory oxygen fraction (PaO2/FiO2) ratio

    Calculation of the arterial partial oxygen tension to inspiratory oxygen fraction (PaO2/FiO2) ratio using arterial oxygen tension measurement

    Measured: On day 1, 3, 5, 7, 10, 14, 21 during mechanical ventilation

  4. Optimum positive end-expiratory pressure (PEEP) level

    Positive end-expiratory pressure (PEEP) selection at minimum level with maximum static compliance and the highest peripheral capillary oxygen saturation over fraction of inspired oxygen (SpO2/FiO2)

    Measured: On day 3, 5, 10, 14, 21 during mechanical ventilation

  5. Change in driving pressure with different positive end-expiratory pressure (PEEP) levels

    Driving pressure calculation at different positive end-expiratory pressure (PEEP) levels (8, 10, 12, 14)

    Measured: On day 1, 3, 5, 7, 10, 14, 21 during mechanical ventilation

Timeline

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

  1. First posted24 Jun 2020
  2. Study start1 May 2020
  3. Primary completion14 Aug 2020
  4. Study completion14 Aug 2020

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
Case only
Time perspective
Prospective
Enrolment
117 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04445961
Sponsor's protocol ID
COVID-VENT
Acronym
COVID-VENT
Status last verified
Jun 2020
First submitted
22 Jun 2020
Last updated
27 Aug 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Amato MB, Meade MO, Slutsky AS, Brochard L, Costa EL, Schoenfeld DA, Stewart TE, Briel M, Talmor D, Mercat A, Richard JC, Carvalho CR, Brower RG. Driving pressure and survival in the acute respiratory distress syndrome. N Engl J Med. 2015 Feb 19;372(8):747-55. doi: 10.1056/NEJMsa1410639.

    PubMed 25693014

  • Gattinoni L, Chiumello D, Caironi P, Busana M, Romitti F, Brazzi L, Camporota L. COVID-19 pneumonia: different respiratory treatments for different phenotypes? Intensive Care Med. 2020 Jun;46(6):1099-1102. doi: 10.1007/s00134-020-06033-2. Epub 2020 Apr 14. No abstract available.

    PubMed 32291463

  • Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.

    PubMed 32031570

  • Toufen Junior C, De Santis Santiago RR, Hirota AS, Carvalho ARS, Gomes S, Amato MBP, Carvalho CRR. Driving pressure and long-term outcomes in moderate/severe acute respiratory distress syndrome. Ann Intensive Care. 2018 Dec 7;8(1):119. doi: 10.1186/s13613-018-0469-4.

    PubMed 30535520

  • Yaroshetskiy AI, Avdeev SN, Politov ME, Nogtev PV, Beresneva VG, Sorokin YD, Konanykhin VD, Krasnoshchekova AP, Merzhoeva ZM, Tsareva NA, Trushenko NV, Mandel IA, Yavorovskiy AG. Potential for the lung recruitment and the risk of lung overdistension during 21 days of mechanical ventilation in patients with COVID-19 after noninvasive ventilation failure: the COVID-VENT observational trial. BMC Anesthesiol. 2022 Mar 4;22(1):59. doi: 10.1186/s12871-022-01600-0.

    PubMed 35246024

Questions about this trial

What is this clinical trial studying?

An observational study of SARS Pneumonia, run by I.M. Sechenov First Moscow State Medical University at 3 sites in Russia.

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 1 inclusion and 6 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: finished, as of the sponsor's last update on 27 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Russia. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Optimum positive end-expiratory pressure (PEEP) level (time frame: On day 1 during mechanical ventilation). The study lists 4 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 NCT04445961, which also lists 5 linked publications.

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 27 Aug 2020.

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