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NCT05150847 Clinical Trial

Prone Positioning in COVID-19 Patients

ARDS Clinical Trial

Official title:
The Effect of Prone Positioning on Oxygenation and Respiratory Mechanics in Patients With COVID-19 Pneumonia

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05150847
Other study ID # 2021/11-02
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 25, 2021
Est. completion date April 13, 2022

Study information
Verified date January 2022
Source Tepecik Training and Research Hospital
Contact KAZIM ROLLAS
Phone +905532787535
Email kazim.rollas@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Prone positioning improves oxygenation in patients with ARDS (1-3). Patients with severe ARDS due to COVID-19 are candidates for prone position. It should be started within 36-48 h and maintained 1, 3). Prone ventilationARDS based on a randomized trial that showed a mortality benefit (PROSEVA) (3). The improvement of oxygenation occurs by making ventilation more homogeneous, limiting ventilator-associated lung injury (4-6). Prone positioning was as effective in improving oxygenation, static respiratory system compliance (Crs) (7). Higher PEEP should be applied when there is a high recruitability potential of the lung. This study aimed to investigate whether prone positioning changes the recruitability position of the lung.in COVID-ARDS.

Description:

Prone positioning improves oxygenation in patients with ARDS (1-3). Patients with severe ARDS due to COVID-19 are candidates for prone position. It should be started within 36-48 h and maintained 1, 3). Prone ventilationARDS based on a randomized trial that showed a mortality benefit (PROSEVA) (3). The improvement of oxygenation occurs by making ventilation more homogeneous, limiting ventilator-associated lung injury (4-6). Prone positioning was as effective in improving oxygenation, static respiratory system compliance (Crs) (7).Higher PEEP should be applied when there is a high recruitability potential of the lung. This study aimed to investigate whether prone positioning changes the oxygenation, respiratory mechanics and recruitability position of the lung in COVID-ARDS.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date April 13, 2022
Est. primary completion date February 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult patients with laboratory-confirmed COVID-19 admitted to the ICU - The patients receive invasive mechanical ventilation and meet the criteria for ARDS (Berlin definition) (8), with under continuous infusion of sedatives, Exclusion Criteria: - Pregnancy - Pneumothorax and or chest tube - Chronic obstructive lung disease - interstitial lung disease - intraabdominal hypertension - increase in intracranial blood pressure - Haemodynamic unstability requiring vasopressors

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Oxygenation
Oxygenation will be calculated as PaO2/ FiO2 ratio.Static compliance will be calculated as tidal volume divided driving pressure.The potential for lung recruitment will be assessed by means of the R/I ratio (10).

Locations
Country Name City State
Turkey Kazim Rollas Izmir

Sponsors (1)
Lead Sponsor Collaborator
Tepecik Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (10)

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

Cornejo RA, Díaz JC, Tobar EA, Bruhn AR, Ramos CA, González RA, Repetto CA, Romero CM, Gálvez LR, Llanos O, Arellano DH, Neira WR, Díaz GA, Zamorano AJ, Pereira GL. Effects of prone positioning on lung protection in patients with acute respiratory distress syndrome. Am J Respir Crit Care Med. 2013 Aug 15;188(4):440-8. doi: 10.1164/rccm.201207-1279OC. — View Citation

Douglas WW, Rehder K, Beynen FM, Sessler AD, Marsh HM. Improved oxygenation in patients with acute respiratory failure: the prone position. Am Rev Respir Dis. 1977 Apr;115(4):559-66. — View Citation

Guerin C, Gaillard S, Lemasson S, Ayzac L, Girard R, Beuret P, Palmier B, Le QV, Sirodot M, Rosselli S, Cadiergue V, Sainty JM, Barbe P, Combourieu E, Debatty D, Rouffineau J, Ezingeard E, Millet O, Guelon D, Rodriguez L, Martin O, Renault A, Sibille JP, Kaidomar M. Effects of systematic prone positioning in hypoxemic acute respiratory failure: a randomized controlled trial. JAMA. 2004 Nov 17;292(19):2379-87. — View Citation

Guérin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girard R, Baboi L, Ayzac L; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68. doi: 10.1056/NEJMoa1214103. Epub 2013 May 20. — View Citation

Lai-Fook SJ, Rodarte JR. Pleural pressure distribution and its relationship to lung volume and interstitial pressure. J Appl Physiol (1985). 1991 Mar;70(3):967-78. Review. — View Citation

Mancebo J, Fernández R, Blanch L, Rialp G, Gordo F, Ferrer M, Rodríguez F, Garro P, Ricart P, Vallverdú I, Gich I, Castaño J, Saura P, Domínguez G, Bonet A, Albert RK. A multicenter trial of prolonged prone ventilation in severe acute respiratory distress syndrome. Am J Respir Crit Care Med. 2006 Jun 1;173(11):1233-9. Epub 2006 Mar 23. — View Citation

Park J, Lee HY, Lee J, Lee SM. Effect of prone positioning on oxygenation and static respiratory system compliance in COVID-19 ARDS vs. non-COVID ARDS. Respir Res. 2021 Aug 6;22(1):220. doi: 10.1186/s12931-021-01819-4. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Oxygenation PaO2/FiO2 intubation + 48 hours
Secondary Static compliance Tidal volume divided driving pressure intubation + 48 hours
Secondary Recruitability recruitment to inflation ratio intubation + 48 hours
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