Respiratory Mechanics and Gas Exchange Characteristics in Patient With SARS-CoV-2

NCT04486729 | Unknown DMC

• 1 other identifier: 10.2020
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The combination of different ventilatory strategies and its effects on respiratory mechanics and gas exchange in patients under mechanical ventilation with acute respiratory distress syndrome secondary to coronavirus-19 has been scarcely described.

Conditions

Covid19; ARDS, Human

Outcome Measures

Primary Outcomes (3)

• Driving transpulmonary pressure (cmH2O)

  The driving transpulmonary pressure will be evaluated between the high and low PEEP condition using the formula: driving transpulmonary pressure = driving airway pressure - driving esophageal pressure (cmH2O).

  10 minutes

• Bohr dead space fraction (%)

  The Bohr dead space fraction will be evaluated with high PEEP between the condition with end inspiratory pause and with no end inspiratory pause application using the formula: Bohr dead space fraction = Alveolar pressure of CO2 (PACO2) - Expired pressure of CO2 (PECO2) / PACO2

  10 minutes

• Shunt fraction (%)

  The shunt fraction will be evaluated with low PEEP between the condition with high fraction of oxygen to achieve a saturation goal of 96-98% and the condition with low fraction of oxygen to achieve a saturation goal of 88-92%. The shunt fraction will be calculated using the formula: Qs/Qt = (capillary oxygen content - arterial oxygen content)/(capillary oxygen content - venous oxygen content)

  10 minutes

Interventions

High PEEP with end inspiratory pause OTHER

Applying a PEEP value 10 cmH2O higher than the lower inflection point of the pressure-volume curve of the respiratory system with end inspiratory pause addition in volumen control ventilation

Low PEEP - FiO2 high OTHER

Applying a PEEP value equal to the lower inflection point of the pressure-volume curve of the respiratory system with a FiO2 necessary to achieve a SpO2 96-98%

High PEEP without end inspiratory pause OTHER

Applying a PEEP value 10 cmH2O higher than the lower inflection point of the pressure-volume curve of the respiratory system without end inspiratory pause addition in volumen control ventilation

Low PEEP - FiO2 low OTHER

Applying a PEEP value equal to the lower inflection point of the pressure-volume curve of the respiratory system with a FiO2 necessary to achieve a SpO2 88-92%

Eligibility Criteria

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

Study Population

Patients with ARDS secondary to COVID-19 under invasive mechanical ventilation

You may qualify if:

• Older than 18 years old
• less than 72 hs since ARDS diagnosis
• Moderate to severe ARDS
• central venous catheter and arterial line available
• Need of neuromuscular blocking agents
• Supine position
• Informed consent accepted
• Airway opening pressure lower than 20 cmH2O

You may not qualify if:

• RASS target higher than -5
• COPD diagnosis
• Pneumothorax
• Intracraneal Hypertension
• Pregnancy
• Cardiac inssuficiency uncompensated
• Chest wall deformity
• Bronchopleural fistula
• Contraindication to use esophageal manometry

Sponsors & Collaborators

• Sanatorio Anchorena San Martin: lead

Study Sites (1)

Sanatorio Anchorena San Martin

San Martín, Buenos Aires, Argentina

RECRUITING

Related Publications (18)

• Guo T, Fan Y, Chen M, Wu X, Zhang L, He T, Wang H, Wan J, Wang X, Lu Z. Cardiovascular Implications of Fatal Outcomes of Patients With Coronavirus Disease 2019 (COVID-19). JAMA Cardiol. 2020 Jul 1;5(7):811-818. doi: 10.1001/jamacardio.2020.1017.

  PMID: 32219356 BACKGROUND

• Ziehr DR, Alladina J, Petri CR, Maley JH, Moskowitz A, Medoff BD, Hibbert KA, Thompson BT, Hardin CC. Respiratory Pathophysiology of Mechanically Ventilated Patients with COVID-19: A Cohort Study. Am J Respir Crit Care Med. 2020 Jun 15;201(12):1560-1564. doi: 10.1164/rccm.202004-1163LE. No abstract available.

  PMID: 32348678 BACKGROUND

• ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.

  PMID: 22797452 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 BACKGROUND

• Chen L, Del Sorbo L, Grieco DL, Junhasavasdikul D, Rittayamai N, Soliman I, Sklar MC, Rauseo M, Ferguson ND, Fan E, Richard JM, Brochard L. Potential for Lung Recruitment Estimated by the Recruitment-to-Inflation Ratio in Acute Respiratory Distress Syndrome. A Clinical Trial. Am J Respir Crit Care Med. 2020 Jan 15;201(2):178-187. doi: 10.1164/rccm.201902-0334OC.

  PMID: 31577153 BACKGROUND

• Tusman G, Gogniat E, Madorno M, Otero P, Dianti J, Ceballos IF, Ceballos M, Verdier N, Bohm SH, Rodriguez PO, San Roman E. Effect of PEEP on Dead Space in an Experimental Model of ARDS. Respir Care. 2020 Jan;65(1):11-20. doi: 10.4187/respcare.06843. Epub 2019 Oct 15.

  PMID: 31615922 BACKGROUND

• Aguirre-Bermeo H, Moran I, Bottiroli M, Italiano S, Parrilla FJ, Plazolles E, Roche-Campo F, Mancebo J. End-inspiratory pause prolongation in acute respiratory distress syndrome patients: effects on gas exchange and mechanics. Ann Intensive Care. 2016 Dec;6(1):81. doi: 10.1186/s13613-016-0183-z. Epub 2016 Aug 24.

  PMID: 27558174 BACKGROUND

• Santos C, Ferrer M, Roca J, Torres A, Hernandez C, Rodriguez-Roisin R. Pulmonary gas exchange response to oxygen breathing in acute lung injury. Am J Respir Crit Care Med. 2000 Jan;161(1):26-31. doi: 10.1164/ajrccm.161.1.9902084.

  PMID: 10619793 BACKGROUND

• Pan C, Chen L, Lu C, Zhang W, Xia JA, Sklar MC, Du B, Brochard L, Qiu H. Lung Recruitability in COVID-19-associated Acute Respiratory Distress Syndrome: A Single-Center Observational Study. Am J Respir Crit Care Med. 2020 May 15;201(10):1294-1297. doi: 10.1164/rccm.202003-0527LE. No abstract available.

  PMID: 32200645 BACKGROUND

• Chen L, Del Sorbo L, Grieco DL, Shklar O, Junhasavasdikul D, Telias I, Fan E, Brochard L. Airway Closure in Acute Respiratory Distress Syndrome: An Underestimated and Misinterpreted Phenomenon. Am J Respir Crit Care Med. 2018 Jan 1;197(1):132-136. doi: 10.1164/rccm.201702-0388LE. No abstract available.

  PMID: 28557528 BACKGROUND

• Tobin MJ. Basing Respiratory Management of COVID-19 on Physiological Principles. Am J Respir Crit Care Med. 2020 Jun 1;201(11):1319-1320. doi: 10.1164/rccm.202004-1076ED. No abstract available.

  PMID: 32281885 BACKGROUND

• Talmor D, Sarge T, Malhotra A, O'Donnell CR, Ritz R, Lisbon A, Novack V, Loring SH. Mechanical ventilation guided by esophageal pressure in acute lung injury. N Engl J Med. 2008 Nov 13;359(20):2095-104. doi: 10.1056/NEJMoa0708638. Epub 2008 Nov 11.

  PMID: 19001507 BACKGROUND

• Yoshida T, Amato MBP, Grieco DL, Chen L, Lima CAS, Roldan R, Morais CCA, Gomes S, Costa ELV, Cardoso PFG, Charbonney E, Richard JM, Brochard L, Kavanagh BP. Esophageal Manometry and Regional Transpulmonary Pressure in Lung Injury. Am J Respir Crit Care Med. 2018 Apr 15;197(8):1018-1026. doi: 10.1164/rccm.201709-1806OC.

  PMID: 29323931 BACKGROUND

• Tahvanainen J, Meretoja O, Nikki P. Can central venous blood replace mixed venous blood samples? Crit Care Med. 1982 Nov;10(11):758-61. doi: 10.1097/00003246-198211000-00012.

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• Monnet X, Teboul JL. Passive leg raising: five rules, not a drop of fluid! Crit Care. 2015 Jan 14;19(1):18. doi: 10.1186/s13054-014-0708-5. No abstract available.

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• Iannuzzi M, De Sio A, De Robertis E, Piazza O, Servillo G, Tufano R. Different patterns of lung recruitment maneuvers in primary acute respiratory distress syndrome: effects on oxygenation and central hemodynamics. Minerva Anestesiol. 2010 Sep;76(9):692-8. Epub 2010 May 14.

  PMID: 20820146 BACKGROUND

• Odenstedt H, Lindgren S, Olegard C, Erlandsson K, Lethvall S, Aneman A, Stenqvist O, Lundin S. Slow moderate pressure recruitment maneuver minimizes negative circulatory and lung mechanic side effects: evaluation of recruitment maneuvers using electric impedance tomography. Intensive Care Med. 2005 Dec;31(12):1706-14. doi: 10.1007/s00134-005-2799-6. Epub 2005 Sep 22.

  PMID: 16177920 BACKGROUND

• Dorado JH, Perez J, Navarro E, Gogniat E, Torres S, Cagide S, Accoce M. Impact of liberal versus conservative saturation targets on gas exchange indices in COVID-19 related acute respiratory distress syndrome: a physiological study. Rev Bras Ter Intensiva. 2021 Oct-Dec;33(4):537-543. doi: 10.5935/0103-507X.20210081. Epub 2022 Jan 24.

  PMID: 35081237 DERIVED

MeSH Terms

Conditions

COVID-19; Respiratory Distress Syndrome

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; Respiration Disorders

Central Study Contacts

Javier H Dorado, PT

CONTACT

(054) 114164 4262; javierhdorado@gmail.com

Joaquin Pérez, PT

CONTACT

(054) 02245 505907; licjoaquinperez@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of physical therapy department

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: July 27, 2020
• Study Start: July 1, 2020
• Primary Completion: October 10, 2020
• Study Completion: October 20, 2020
• Last Updated: July 27, 2020

Record last verified: 2020-07

Locations

AR (1)