The Prone Position in Covid-19 Affected Patients (PRON-COVID)

• ClinicalTrials.gov Identifier: NCT04365959
• Recruitment Status: Active, not recruiting
• First Posted: April 28, 2020
• Last Update Posted: November 9, 2020
• Sponsor: University of Milano Bicocca
• Information provided by (Responsible Party): University of Milano Bicocca

Study Description

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.

Condition or disease	Intervention/treatment
Sars-CoV2	Procedure: Prone position

Detailed Description:

BACKGROUND:

It has been shown that the prone position (PP) during mechanical ventilation (VM) in patients with Acute Respiratory Distress Syndrome (ARDS) is able to improve oxygenation and thus reduce mortality.

The reduced mortality, however, is not only caused by an increase in oxygen, but also by the ability of the PP to reduce the damage associated with mechanical ventilation (VILI).

Studies show that the benefits of PP are also present in non-intubated patients; the PP prevents the need for intubation and the consequent risk deriving from the procedure itself and from the predisposition to develop superinfections (VAP).

Moreover, a reduction in the need for intubation and therefore hospitalization in the ICU would be particularly useful in a context of great health emergency with limited resources.

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.

STUDY DESIGN:

This is a monocentric study that 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.

Sample size (n. Patients): 56

The duration of enrollment is estimated in 1 month. Patients will be monitored until discharged from the hospital. The overall duration of the study is estimated to be 1 year (including enrollment, follow up and data analysis).

The patient will be enrolled in the study when consent is obtained. The following data will be collected:

• Patient registration
• Demographic and anthropometric data
• Comorbidity and lifestyle habits
• Hospitalization data
• Blood chemistry tests
• Ventilation parameters

After 10 minutes and at the end of pronation, the feasibility of pronation and ventilation parameters will also be assessed.

STATISTICAL ANALYSIS:

Clinical data relating to enrolled patients will be analysed by means of descriptive statistics on continuous quantitative variables using indicators chosen on the basis of the distributional form. Categorical variables will be described in percentages. Hypotheses on PaO2 / FiO2 performance will be verified through the T test for paired data if the distributional form allows it or alternatively the Wilcoxon test will be used. In this case we will proceed with a recalculation of the power study.

Study Design

• Study Type: Observational
• Actual Enrollment: 56 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Study of the Feasibility and Usefulness of the Prone Position in Patients With Respiratory Distress From Covid-19 Not Intubated, in Spontaneous Breath in Oxygen Therapy or Cpap
• Actual Study Start Date: March 20, 2020
• Actual Primary Completion Date: April 9, 2020
• Estimated Study Completion Date: December 31, 2020

Groups and Cohorts

Group/Cohort	Intervention/treatment
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; 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).; Other Name: PP

Outcome Measures

Primary Outcome Measures :

1. Number of patients in whom the prone position caused an increase in oxygenation [ Time Frame: Until patient discharge from the hospital (approximately 1 month after enrollment) ]
   Measure the ability of the prone position to increase the oxygenation of the patient with SARS-cov-2 pneumonia as a lung recruitment index.

Secondary Outcome Measures :

1. The feasibility of prone position [ Time Frame: Until patient discharge from the hospital (approximately 1 month after enrollment) ]
   Measure the feasibility of the prone position in terms of patient comfort and health resources in a context of a national health emergency.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

Italy

ASST Monza

Monza, MB, Italy, 20900

Sponsors and Collaborators

University of Milano Bicocca

Investigators

• Principal Investigator: Giuseppe Foti, Prof.; ASST Monza-University Milano Bicocca

More Information

Publications:

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.

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

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. Erratum in: Lancet Respir Med. 2020 Apr;8(4):e26.

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.

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.

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. Epub 2007 Mar 29.

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.

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.

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.

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.

Valter C, Christensen AM, Tollund C, Schønemann NK. Response to the prone position in spontaneously breathing patients with hypoxemic respiratory failure. Acta Anaesthesiol Scand. 2003 Apr;47(4):416-8.

Scaravilli V, Grasselli G, Castagna L, Zanella A, Isgrò 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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University of Milano Bicocca
• ClinicalTrials.gov Identifier: NCT04365959
• Other Study ID Numbers: PRON-COVID
• First Posted: April 28, 2020
• Last Update Posted: November 9, 2020
• Last Verified: November 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Milano Bicocca:

COVID-19; sars-covid-2