Early Prone Position on Coronavirus Disease 2019 Pneumonia
NCT ID: NCT04427969
Last Updated: 2020-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
33 participants
OBSERVATIONAL
2020-06-15
2020-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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EPP
patients who applied early awake prone position for treatment with conventional oxygen supply
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
No interventions assigned to this group
Interventions
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prone position
to lay in prone position at least 12 hour in a day at ICU
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Sisli Hamidiye Etfal Training and Research Hospital
OTHER
Responsible Party
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Mustafa Altınay
spercialist medical doctor
Principal Investigators
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ayse surhan cinar
Role: STUDY_CHAIR
chief of anesthesia department
Locations
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Sisli Etfal Research and Training Hospital
Istanbul, Marmara, Turkey (Türkiye)
Countries
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References
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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.
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.
Kallet RH. A Comprehensive Review of Prone Position in ARDS. Respir Care. 2015 Nov;60(11):1660-87. doi: 10.4187/respcare.04271.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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pp34
Identifier Type: -
Identifier Source: org_study_id