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

Covid19 Clinical Trial

Official title:

Respiratory System Mechanics and Gas Exchange Characteristics Applying Different Ventilatory Strategies in Patients With SARS-CoV-2

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04486729
• Other study ID #: 10.2020
• Status: Recruiting
• Start date: July 1, 2020
• Est. completion date: October 20, 2020

Study information

• Verified date: July 2020
• Source: Sanatorio Anchorena San Martin
• Contact: Javier H Dorado, PT
• Phone: (054) 114164 4262
• Email: javierhdorado[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Investigation in mechanically ventilated patients with with acute respiratory distress syndrome (ARDS) secondary to coronavirus-19 (COVID-19) is emerging due to presumed differences with typical ARDS from other origin. Considering these issues, the effects of ventilatory strategies such as positive end expiratory pressure, end inspiratory pause and fraction of inspired oxygen on respiratory mechanics and gas exchange must be studied in order to characterize the behavior of COVID-19 ARDS during invasive mechanical ventilation and choose the best combination of ventilatory settings.

In this study the investigators will evaluate the changes in respiratory mechanics and gas exchange produced by low and high positive end expiratory pressure, low and high inspired oxygen fraction and the application of end inspiratory pause during volume controlled mechanical ventilation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: October 20, 2020
• Est. primary completion date: October 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• RASS target higher than -5

• COPD diagnosis

• Pneumothorax

• Intracraneal Hypertension

• Pregnancy

• Cardiac inssuficiency uncompensated

• Chest wall deformity

• Bronchopleural fistula

• Contraindication to use esophageal manometry

Related Conditions & MeSH terms

• ARDS, Human
• Covid19
• Respiratory Distress Syndrome, Adult

Intervention

Other:
• High PEEP with end inspiratory pause
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
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
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
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%

Locations

Country	Name	City	State
Argentina	Sanatorio Anchorena San Martin	San Martin	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Sanatorio Anchorena San Martin

Country where clinical trial is conducted

Argentina, 

References & Publications (18)

Aguirre-Bermeo H, Morán 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. — View Citation

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. — View Citation

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. — View Citation

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. — View 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. — View Citation

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 Mar 27. doi: 10.1001/jamacardio.2020.1017. [Epub ahead of print] — View Citation

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. — View Citation

Mauri T, Spinelli E, Scotti E, Colussi G, Basile MC, Crotti S, Tubiolo D, Tagliabue P, Zanella A, Grasselli G, Pesenti A. Potential for Lung Recruitment and Ventilation-Perfusion Mismatch in Patients With the Acute Respiratory Distress Syndrome From Coronavirus Disease 2019. Crit Care Med. 2020 Apr 17. doi: 10.1097/CCM.0000000000004386. [Epub ahead of print] — View Citation

Monnet X, Teboul JL. Passive leg raising: five rules, not a drop of fluid! Crit Care. 2015 Jan 14;19:18. doi: 10.1186/s13054-014-0708-5. — View Citation

Odenstedt H, Lindgren S, Olegård 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. Epub 2005 Sep 22. — View Citation

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. — View Citation

Santos C, Ferrer M, Roca J, Torres A, Hernández 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. — View Citation

Tahvanainen J, Meretoja O, Nikki P. Can central venous blood replace mixed venous blood samples? Crit Care Med. 1982 Nov;10(11):758-61. — View Citation

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. — View Citation

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. — View Citation

Tusman G, Gogniat E, Madorno M, Otero P, Dianti J, Ceballos IF, Ceballos M, Verdier N, Böhm 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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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