Clinical trial NCT04445961: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS Pneumonia
Keywords: SARS Pneumonia
ARDS
COVID-19
compliance
recruitability
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
First posted: 2020-06-24
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with COVID-19 requiring respiratory support

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.

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.

Primary outcomes:
measure: Optimum positive end-expiratory pressure (PEEP) level
timeFrame: On day 1 during mechanical ventilation
measure: Optimum positive end-expiratory pressure (PEEP) level
timeFrame: On day 7 during mechanical ventilation
measure: Number of patients with recruitable lung
timeFrame: On day 1 during mechanical ventilation
measure: Number of patients with recruitable lung
timeFrame: On day 7 during mechanical ventilation
Secondary outcomes:
measure: Change in alveolar dead space
timeFrame: On day 1, 3, 5, 7, 10, 14, 21 during mechanical ventilation
measure: Change in plethysmogram variability during recruitment maneuver
timeFrame: On day 1, 3, 5, 7, 10, 14, 21 during mechanical ventilation
measure: Change in arterial partial oxygen tension to inspiratory oxygen fraction (PaO2/FiO2) ratio
timeFrame: On day 1, 3, 5, 7, 10, 14, 21 during mechanical ventilation
measure: Optimum positive end-expiratory pressure (PEEP) level
timeFrame: On day 3, 5, 10, 14, 21 during mechanical ventilation
measure: Change in driving pressure with different positive end-expiratory pressure (PEEP) levels
timeFrame: On day 1, 3, 5, 7, 10, 14, 21 during mechanical ventilation
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Sechenov University Clinic #1
city: Moscow
country: Russian Federation
facility: Sechenov University Clinic #3
city: Moscow
country: Russian Federation
facility: Sechenov University Clinic #4
Study officials:
affiliation: Sechenov University
name: Andrey I Yaroshetskiy, Dr.Med.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.