- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04427969
Early Prone Position on Coronavirus Disease 2019 Pneumonia (Prone Position)
The Effect of Early Prone Position on Prognosis in Acute Respiratory Failure Due to Coronavirus Disease 2019 Pneumonia
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Marmara
-
Istanbul, Marmara, Turkey, 34400
- Sisli Etfal Research and Training Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
EPP
patients who applied early awake prone position for treatment with conventional oxygen supply
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
intensive care unit stay
Time Frame: up to 28 days
|
the duration of icu stay day
|
up to 28 days
|
short term mortality
Time Frame: up to 28 days
|
mortality percent
|
up to 28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
blood gases
Time Frame: up to 24 hours
|
partial oxygen pressure: mmhg , partial carbondiocsit pressure mmhg
|
up to 24 hours
|
Collaborators and Investigators
Investigators
- Study Chair: ayse surhan cinar, chief of anesthesia department
Publications and helpful links
General Publications
- 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.
- 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.
- Kallet RH. A Comprehensive Review of Prone Position in ARDS. Respir Care. 2015 Nov;60(11):1660-87. doi: 10.4187/respcare.04271.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Respiration Disorders
- Pneumonia, Viral
- Lung Diseases
- COVID-19
- Coronavirus Infections
- Respiratory Insufficiency
- Pneumonia
- Respiratory Distress Syndrome
Other Study ID Numbers
- pp34
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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