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

NCT04445961 | Completed DMC

• 1 other identifier: COVID-VENT
• Study Type: observational
• Target: 117
• Locations: 1 country
• Sites: 3

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.

Conditions

SARS Pneumonia

Keywords

SARS Pneumonia; ARDS; COVID-19; compliance; recruitability

Outcome Measures

Primary Outcomes (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)

  On day 1 during mechanical ventilation

• 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)

  On day 7 during mechanical ventilation

• 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

  On day 1 during mechanical ventilation

• 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

  On day 7 during mechanical ventilation

Secondary Outcomes (5)

• Change in alveolar dead space

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

• Change in plethysmogram variability during recruitment maneuver

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

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

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

• Optimum positive end-expiratory pressure (PEEP) level

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

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

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

Interventions

Respiratory mechanics measurement DIAGNOSTIC_TEST

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

Gas exchange measurement DIAGNOSTIC_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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with COVID-19 requiring respiratory support

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (3)

Sechenov University Clinic #1

Moscow, Russia

Location

Sechenov University Clinic #3

Moscow, Russia

Location

Sechenov University Clinic #4

Moscow, Russia

Location

Related Publications (5)

• 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.

  PMID: 25693014 BACKGROUND

• 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.

  PMID: 32291463 RESULT

• 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.

  PMID: 32031570 RESULT

• 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.

  PMID: 30535520 RESULT

• 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.

  PMID: 35246024 DERIVED

MeSH Terms

Conditions

COVID-19; Patient Compliance

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Andrey I Yaroshetskiy, Dr.Med.Sc.

  Sechenov University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 24, 2020
• Study Start: May 1, 2020
• Primary Completion: August 14, 2020
• Study Completion: August 14, 2020
• Last Updated: August 27, 2020

Record last verified: 2020-06

Locations

RU (3)