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

• ClinicalTrials.gov Identifier: NCT04445961
• Recruitment Status: Completed
• First Posted: June 24, 2020
• Last Update Posted: August 27, 2020
• Sponsor: I.M. Sechenov First Moscow State Medical University
• Information provided by (Responsible Party): I.M. Sechenov First Moscow State Medical University

Tracking Information

• First Submitted Date: June 22, 2020
• First Posted Date: June 24, 2020
• Last Update Posted Date: August 27, 2020
• Actual Study Start Date: May 1, 2020
• Actual Primary Completion Date: August 14, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 23, 2020)

• Optimum positive end-expiratory pressure (PEEP) level [ Time Frame: On day 1 during mechanical ventilation ]
  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)
• Optimum positive end-expiratory pressure (PEEP) level [ Time Frame: On day 7 during mechanical ventilation ]
  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)
• Number of patients with recruitable lung [ Time Frame: On day 1 during mechanical ventilation ]
  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
• Number of patients with recruitable lung [ Time Frame: On day 7 during mechanical ventilation ]
  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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 23, 2020)

• Change in alveolar dead space [ Time Frame: On day 1, 3, 5, 7, 10, 14, 21 during mechanical ventilation ]
  Calculation of the alveolar dead space using end-tidal carbon dioxide measurement and arterial carbon dioxide tension measurement
• Change in plethysmogram variability during recruitment maneuver [ Time Frame: On day 1, 3, 5, 7, 10, 14, 21 during mechanical ventilation ]
  Measurement of plethysmogram variability before and during recruitment maneuver
• Change in arterial partial oxygen tension to inspiratory oxygen fraction (PaO2/FiO2) ratio [ Time Frame: On day 1, 3, 5, 7, 10, 14, 21 during mechanical ventilation ]
  Calculation of the arterial partial oxygen tension to inspiratory oxygen fraction (PaO2/FiO2) ratio using arterial oxygen tension measurement
• Optimum positive end-expiratory pressure (PEEP) level [ Time Frame: On day 3, 5, 10, 14, 21 during mechanical ventilation ]
  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)
• Change in driving pressure with different positive end-expiratory pressure (PEEP) levels [ Time Frame: On day 1, 3, 5, 7, 10, 14, 21 during mechanical ventilation ]
  Driving pressure calculation at different positive end-expiratory pressure (PEEP) levels (8, 10, 12, 14)

• 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: Respiratory Mechanics and Gas Exchange in Patients With COVID-19 and Hypoxemic Acute Respiratory Failure
• Official Title: Respiratory Mechanics and Gas Exchange in Patients With COVID-19 and Hypoxemic Acute Respiratory Failure: Multicentral Observational Study
• Brief 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. 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.

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.

• Study Type: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: All patients with COVID-19 requiring respiratory support
• Condition: SARS Pneumonia

Intervention

• Diagnostic Test: Respiratory mechanics measurement
  Measurement of peak inspiratory pressure, plateau pressure, calculation of static compliance and driving pressure
• Diagnostic Test: Gas exchange measurement
  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

• Study Groups/Cohorts: Not Provided

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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 26, 2020): 117
• Original Estimated Enrollment (submitted: June 23, 2020): 70
• Actual Study Completion Date: August 14, 2020
• Actual Primary Completion Date: August 14, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Russian Federation

Administrative Information

• NCT Number: NCT04445961
• Other Study ID Numbers: COVID-VENT
• Has Data Monitoring Committee: Yes

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: Not Provided
• Responsible Party: I.M. Sechenov First Moscow State Medical University
• Study Sponsor: I.M. Sechenov First Moscow State Medical University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Andrey I Yaroshetskiy, Dr.Med.Sc.; Sechenov University

• PRS Account: I.M. Sechenov First Moscow State Medical University
• Verification Date: June 2020