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The prone position consists of placing the patient on his or her stomach with the head on the side, during sessions lasting several hours a day and could help spontaneous ventilate the patient.
SARS-CoV-2 is an RNA virus whose tropism for the respiratory system is responsible for many cases of acute respiratory failure. This can lead to acute respiratory distress syndrome (ARDS) requiring orotracheal intubation and mechanical ventilation. The prone position is a validated intensive care technique in the treatment of ARDS in mechanically ventilated patients. Performing prone position sessions improves patient oxygenation by optimizing the ventilation/perfusion ratios of the posterior areas of the lungs.
There is limited data in the literature on the ventral decubitus in spontaneous ventilation. They are mainly case series or retrospective studies. In the case of the SARS-CoV-2 epidemic, we are seeing patients with posterior lung involvement who may benefit from prone position sessions prior to mechanical ventilation. This maneuver, usually done in an intubated-ventilated-curarized patient, will be done in our spontaneous ventilation study in a conscious patient.The patient will then be placed in prone position with the help of physiotherapists so that the patient is correctly positioned.
The maneuver and the clinical monitoring of the patient's tolerance to the prone position will be done under medical and paramedical supervision, including monitoring of saturation during and after the procedure. A polygraph will also be installed on the patient in order to monitor the patient's position (on the back vs. on the stomach), saturation and heart rate during the entire prone position session. An arterial gasometry will be performed before the patient is placed in the prone position, one hour after and after returning to the supine position.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prone positioning | Experimental | Participants are all turned to prone position for an optimal minimum duration of 3 hours . Tolerance, oxygen saturation, heart rate and position are monitoring during all procedure. Arterial blood gases are realized before, 1 to 2 hours after the beginning of the prone position, and 6 to 12 hours after resupination. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prone positioning | Procedure | The prone positioning consists of placing the patient on his or her stomach with the head on the side, during sessions lasting several hours a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of "responder" patients to prone position | PaO2 improvement of more than 20% after one hour in prone position in spontaneously breathing non intubated COVID-19 patients. | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| proportion of "persistent responders" patients after prone position | PaO2 improvement of more than 20% at 6 to 12 hours from return to supine position. | 1 day |
| Evolution of PaO2 | PaO2 at 1 hour from the start of prone position and at 6 to 12 hours afterreturn to supine position. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xavier ELHARRAR, MD | Contact | 0442335650 | +33 | rechercheclinique@ch-aix.fr |
| Youssef Trigui, MD | Contact | 0033674215193 | rechercheclinique@ch-aix.fr |
| Name | Affiliation | Role |
|---|---|---|
| Xavier ELHARRAR, MD | Centre Hospitalier Intercommunal Aix-Pertuis (CHIAP), France | Principal Investigator |
| Youssef Trigui, MD | Centre Hospitalier Intercommunal Aix-Pertuis (CHIAP), France | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHI Aix-Pertuis | Recruiting | Aix-en-Provence | 13100 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32189136 | Background | Sun Q, Qiu H, Huang M, Yang Y. Lower mortality of COVID-19 by early recognition and intervention: experience from Jiangsu Province. Ann Intensive Care. 2020 Mar 18;10(1):33. doi: 10.1186/s13613-020-00650-2. No abstract available. | |
| 26271685 | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 24, 2021 | |
| Reset | Jun 24, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 24, 2021 | Jun 24, 2021 |
| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D016684 | Prone Position |
| ID | Term |
|---|---|
| D011187 | Posture |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| 1 day |
| Duration of prone positioning and PaO2 evolution | Look for an association between the time spent in Prone positione and persistent responder or not; | 2 days |
| Evolution of Spo2 | proportion of patients improving their arterial saturation within 1 hour of Prone Position | 1 hour |
| EVA Dyspnea | evolution of the EVA scores for dyspnea at 1 hour from the start of the Prone Position and at 6 hours after the end of the Prone Position | 1 day |
| Intolerance to prone positioning | proportion of patients intolerant to prone position (Prone Position <1h); | 1 day |
| Tolerance to prone positioning | proportion of patients who can maintain prone position for more than 3 h. | 1 day |
| Stephanie Martinez, MD | Centre Hospitalier Intercommunal Aix-Pertuis (CHIAP), France | Study Chair |
| Laurence Maulin, MD | Centre Hospitalier Intercommunal Aix-Pertuis (CHIAP), France | Study Chair |
| Marie Bernardi, MD | Centre Hospitalier Intercommunal Aix-Pertuis (CHIAP), France | Study Chair |
| Laurent Lefebvre, MD | Centre Hospitalier Intercommunal Aix-Pertuis (CHIAP), France | Study Chair |
| Thibaut Helbert, MD | Centre Hospitalier Intercommunal Aix-Pertuis (CHIAP), France | Study Chair |
| Camille begne, MD | Centre Hospitalier Intercommunal Aix-Pertuis (CHIAP), France | Study Chair |
| 32000806 | Background | Ding L, Wang L, Ma W, He H. Efficacy and safety of early prone positioning combined with HFNC or NIV in moderate to severe ARDS: a multi-center prospective cohort study. Crit Care. 2020 Jan 30;24(1):28. doi: 10.1186/s13054-020-2738-5. |
| 29068269 | Background | Munshi L, Del Sorbo L, Adhikari NKJ, Hodgson CL, Wunsch H, Meade MO, Uleryk E, Mancebo J, Pesenti A, Ranieri VM, Fan E. Prone Position for Acute Respiratory Distress Syndrome. A Systematic Review and Meta-Analysis. Ann Am Thorac Soc. 2017 Oct;14(Supplement_4):S280-S288. doi: 10.1513/AnnalsATS.201704-343OT. |
| 24134414 | Background | Gattinoni L, Taccone P, Carlesso E, Marini JJ. Prone position in acute respiratory distress syndrome. Rationale, indications, and limits. Am J Respir Crit Care Med. 2013 Dec 1;188(11):1286-93. doi: 10.1164/rccm.201308-1532CI. |
| 23688302 | 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. |
| 32105637 | Background | Shi H, Han X, Jiang N, Cao Y, Alwalid O, Gu J, Fan Y, Zheng C. Radiological findings from 81 patients with COVID-19 pneumonia in Wuhan, China: a descriptive study. Lancet Infect Dis. 2020 Apr;20(4):425-434. doi: 10.1016/S1473-3099(20)30086-4. Epub 2020 Feb 24. |
| D007239 |
| Infections |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |