The Prone Position in Covid-19 Affected Patients

NCT04365959 | Completed DMC

• 1 other identifier: PRON-COVID
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The prone position during mechanical ventilation in patients with Acute Respiratory Distress Syndrome (ARDS) is able to improve oxygenation and thus reduce mortality. The objective of the study is to evaluate the ability of the prone position to increase the oxygenation of the patient with SARS-cov-2 pneumonia.

Conditions

Sars-CoV2

Keywords

COVID-19; sars-covid-2

Outcome Measures

Primary Outcomes (1)

• Number of patients in whom the prone position caused an increase in oxygenation

  Measure the ability of the prone position to increase the oxygenation of the patient with SARS-cov-2 pneumonia as a lung recruitment index.

  Until patient discharge from the hospital (approximately 1 month after enrollment)

Secondary Outcomes (1)

• The feasibility of prone position

  Until patient discharge from the hospital (approximately 1 month after enrollment)

Study Arms (1)

covid-19 pneumonia related patients

This study will be conducted on all patients admitted to the Infectious Diseases and UTIR units of the S. Gerardo Hospital in Monza with the diagnosis of related COVID pneumonia requiring oxygen support or CPAP.

Procedure: Prone position

Interventions

Prone position PROCEDURE

The objective of the study is to value the ability of the prone position to increase the oxygenation of the patient with SARS-cov-2 pneumonia as a lung recruitment index; the PP also prevents the need for intubation and the consequent risk deriving from the procedure itself and from the predisposition to develop superinfections (VAP).

Also known as: PP

covid-19 pneumonia related patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will be conducted on all patients admitted to the Infectious Diseases and UTIR units of the S. Gerardo Hospital in Monza with the diagnosis of related COVID pneumonia requiring oxygen or CPAP support.

You may qualify if:

• Age\> = 18 years old or \<= 75 years old
• Diagnosis of COVID related pneumonia requiring oxygen or CPAP support

You may not qualify if:

• pregnant patients
• patients with impaired consciousness and / or uncooperative
• patients with NYHA class\> II
• patients with high proBNP
• patients with COPD
• contraindications evidenced by the physicians

Sponsors & Collaborators

• University of Milano Bicocca: lead

Study Sites (1)

ASST Monza

Monza, MB, 20900, Italy

Location

Related Publications (13)

• Bouadma L, Lescure FX, Lucet JC, Yazdanpanah Y, Timsit JF. Severe SARS-CoV-2 infections: practical considerations and management strategy for intensivists. Intensive Care Med. 2020 Apr;46(4):579-582. doi: 10.1007/s00134-020-05967-x. Epub 2020 Feb 26. No abstract available.

  PMID: 32103284 BACKGROUND

• Pappert D, Rossaint R, Slama K, Gruning T, Falke KJ. Influence of positioning on ventilation-perfusion relationships in severe adult respiratory distress syndrome. Chest. 1994 Nov;106(5):1511-6. doi: 10.1378/chest.106.5.1511.

  PMID: 7956412 BACKGROUND

• Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24.

  PMID: 32105632 BACKGROUND

• Guerin 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.

  PMID: 23688302 BACKGROUND

• Albert RK, Leasa D, Sanderson M, Robertson HT, Hlastala MP. The prone position improves arterial oxygenation and reduces shunt in oleic-acid-induced acute lung injury. Am Rev Respir Dis. 1987 Mar;135(3):628-33. doi: 10.1164/arrd.1987.135.3.628.

  PMID: 3030168 BACKGROUND

• Hopkins SR, Henderson AC, Levin DL, Yamada K, Arai T, Buxton RB, Prisk GK. Vertical gradients in regional lung density and perfusion in the supine human lung: the Slinky effect. J Appl Physiol (1985). 2007 Jul;103(1):240-8. doi: 10.1152/japplphysiol.01289.2006. Epub 2007 Mar 29.

  PMID: 17395757 BACKGROUND

• Mure M, Glenny RW, Domino KB, Hlastala MP. Pulmonary gas exchange improves in the prone position with abdominal distension. Am J Respir Crit Care Med. 1998 Jun;157(6 Pt 1):1785-90. doi: 10.1164/ajrccm.157.6.9711104.

  PMID: 9620906 BACKGROUND

• Albert RK, Hubmayr RD. The prone position eliminates compression of the lungs by the heart. Am J Respir Crit Care Med. 2000 May;161(5):1660-5. doi: 10.1164/ajrccm.161.5.9901037.

  PMID: 10806172 BACKGROUND

• Broccard AF, Shapiro RS, Schmitz LL, Ravenscraft SA, Marini JJ. Influence of prone position on the extent and distribution of lung injury in a high tidal volume oleic acid model of acute respiratory distress syndrome. Crit Care Med. 1997 Jan;25(1):16-27. doi: 10.1097/00003246-199701000-00007.

  PMID: 8989171 BACKGROUND

• Valenza F, Guglielmi M, Maffioletti M, Tedesco C, Maccagni P, Fossali T, Aletti G, Porro GA, Irace M, Carlesso E, Carboni N, Lazzerini M, Gattinoni L. Prone position delays the progression of ventilator-induced lung injury in rats: does lung strain distribution play a role? Crit Care Med. 2005 Feb;33(2):361-7. doi: 10.1097/01.ccm.0000150660.45376.7c.

  PMID: 15699840 BACKGROUND

• Valter C, Christensen AM, Tollund C, Schonemann NK. Response to the prone position in spontaneously breathing patients with hypoxemic respiratory failure. Acta Anaesthesiol Scand. 2003 Apr;47(4):416-8. doi: 10.1034/j.1399-6576.2003.00088.x.

  PMID: 12694139 BACKGROUND

• Scaravilli V, Grasselli G, Castagna L, Zanella A, Isgro S, Lucchini A, Patroniti N, Bellani G, Pesenti A. Prone positioning improves oxygenation in spontaneously breathing nonintubated patients with hypoxemic acute respiratory failure: A retrospective study. J Crit Care. 2015 Dec;30(6):1390-4. doi: 10.1016/j.jcrc.2015.07.008. Epub 2015 Jul 16.

  PMID: 26271685 BACKGROUND

• Coppo A, Bellani G, Winterton D, Di Pierro M, Soria A, Faverio P, Cairo M, Mori S, Messinesi G, Contro E, Bonfanti P, Benini A, Valsecchi MG, Antolini L, Foti G. Feasibility and physiological effects of prone positioning in non-intubated patients with acute respiratory failure due to COVID-19 (PRON-COVID): a prospective cohort study. Lancet Respir Med. 2020 Aug;8(8):765-774. doi: 10.1016/S2213-2600(20)30268-X. Epub 2020 Jun 19.

  PMID: 32569585 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Prone Position

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

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Giuseppe Foti, Prof.

  ASST Monza-University Milano Bicocca

  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: April 21, 2020
• First Posted: April 28, 2020
• Study Start: March 20, 2020
• Primary Completion: April 9, 2020
• Study Completion: May 9, 2020
• Last Updated: April 29, 2022

Record last verified: 2022-04

Locations

IT (1)