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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

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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


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



Primary Outcome Measures :
  1. intensive care unit stay [ Time Frame: up to 28 days ]
    the duration of icu stay day

  2. short term mortality [ Time Frame: up to 28 days ]
    mortality percent


Secondary Outcome Measures :
  1. 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
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.

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

Publications of Results:
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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