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

Group/Cohort | Intervention/treatment |
---|---|
EPP
patients who applied early awake prone position for treatment with conventional oxygen supply
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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
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- 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
- blood gases [ Time Frame: up to 24 hours ]partial oxygen pressure: mmhg , partial carbondiocsit pressure mmhg

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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 |
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.

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
Turkey | |
Sisli Etfal Research and Training Hospital | |
Istanbul, Marmara, Turkey, 34400 |
Study Chair: | ayse surhan cinar | chief of anesthesia department |
Documents provided by Mustafa Altınay, Sisli Hamidiye Etfal Training and Research Hospital:
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
coronavirus disease 2019 prone position |
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 |