Early Prone Position on Coronavirus Disease 2019 Pneumonia (Prone Position)

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ClinicalTrials.gov Identifier: NCT04427969

Recruitment Status : Completed

First Posted : June 11, 2020

Last Update Posted : November 10, 2020

Sponsor:

Information provided by (Responsible Party):

Mustafa Altınay, Sisli Hamidiye Etfal Training and Research Hospital

Study Description

Brief Summary:

the purpose of this study to evaluate the effect of early awake PP (prone position)application on oxygenation and intubation requirement in patients with acute respiratory failure due to coronavirus disease 2019 pneumonia.

Condition or disease	Intervention/treatment
Coronavirus Infection Acute Respiratory Failure	Behavioral: prone position

Detailed Description:

The first group (early prone position-EPP) created for our study was composed of patients who received PP at least 12 hours early (with the first 48 hours) with the oxygen support of the reservoir mask, and the second group (non-EPP ) patients who received oxygen with the reservoir mask but could not be applied early PP due to the patient's incompatibility or rejection.

Conventional oxygen therapy applied to all patients was given with a reservoir mask, aiming at oxygen saturation 93% and above, at a flow rate of 6-15 L / min.

Despite all the treatments, the patients who have a follow-up with a respiratory acidosis , oxygen saturation value below 93%, applied non invasive mechanical ventilation, in case of insufficient patient intubated and have invasive mechanical ventilation. In patients who had regression of glasgow coma scale during follow-up, orotracheal intubation was performed and invasive mechanical ventilation was performed.

Study Design

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Study Type :	Observational
Actual Enrollment :	33 participants
Observational Model:	Cohort
Time Perspective:	Retrospective
Official Title:	The Effect of Early Prone Position on Prognosis in Acute Respiratory Failure Due to Coronavirus Disease 2019 Pneumonia
Actual Study Start Date :	June 15, 2020
Actual Primary Completion Date :	June 25, 2020
Actual Study Completion Date :	June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Coronavirus Infections Pneumonia Respiratory Failure

Genetic and Rare Diseases Information Center resources: Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Infant Acute Respiratory Distress Syndrome

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
EPP patients who applied early awake prone position for treatment with conventional oxygen supply	Behavioral: prone position to lay in prone position at least 12 hour in a day at ICU
non-EPP patient who only get conventional oxygen therapy as respiratory supply

Outcome Measures

Primary Outcome Measures :

intensive care unit stay [ Time Frame: up to 28 days ]
the duration of icu stay day
short term mortality [ Time Frame: up to 28 days ]
mortality percent

Secondary Outcome Measures :

blood gases [ Time Frame: up to 24 hours ]
partial oxygen pressure: mmhg , partial carbondiocsit pressure mmhg

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

The data of patients over 18 years old who were followed up and treated in the intensive care unit due to acute respiratory failure due to coronavirus disease 2019 pneumonia were retrospectively reviewed.

Criteria

Inclusion Criteria:

Patients who developed acute respiratory failure due to coronavirus disease 2019 pneumonia
received conventional oxygen therapy with reservoir mask oxygen at the stage of admission to the intensive care unit
older than 18 years old

Exclusion Criteria:

patients with respiratory acidosis,
partial oxygen pressure/fraction of inspired oxygen ratio below 150,
Glasgow Coma Score (GKS) below 12 points,
hemodynamic instability,
primary pulmonary pathologies other than pneumonia (lung cancer, cardiopulmonary edema, carcinogen syndrome, etc.)
patients who underwent non-invasive mechanical ventilation(NIMV) or intubated from admission to intensive care,
those who underwent self prone position under 12 hours were not included in the study.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04427969

Locations

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Turkey
Sisli Etfal Research and Training Hospital
Istanbul, Marmara, Turkey, 34400

Sponsors and Collaborators

Sisli Hamidiye Etfal Training and Research Hospital

Investigators

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Study Chair:	ayse surhan cinar	chief of anesthesia department

Study Documents (Full-Text)

Documents provided by Mustafa Altınay, Sisli Hamidiye Etfal Training and Research Hospital:

Study Protocol [PDF] June 5, 2020

Statistical Analysis Plan [PDF] June 5, 2020

More Information

Publications of Results:

Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.

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.

Kallet RH. A Comprehensive Review of Prone Position in ARDS. Respir Care. 2015 Nov;60(11):1660-87. doi: 10.4187/respcare.04271. Review.

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. Review.

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Responsible Party:	Mustafa Altınay, spercialist medical doctor, Sisli Hamidiye Etfal Training and Research Hospital
ClinicalTrials.gov Identifier:	NCT04427969
Other Study ID Numbers:	pp34
First Posted:	June 11, 2020 Key Record Dates
Last Update Posted:	November 10, 2020
Last Verified:	November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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

Keywords provided by Mustafa Altınay, Sisli Hamidiye Etfal Training and Research Hospital:


coronavirus disease 2019 prone position

Additional relevant MeSH terms:

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Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia Respiratory Insufficiency Respiratory Distress Syndrome, Adult Lung Diseases Respiratory Tract Diseases	Respiratory Tract Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Virus Diseases Respiration Disorders

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