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

November 7, 2020 updated by: Mustafa Altınay, Sisli Hamidiye Etfal Training and Research Hospital

The Effect of Early Prone Position on Prognosis in Acute Respiratory Failure Due to Coronavirus Disease 2019 Pneumonia

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.

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

33

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: ayse surhan cinar, chief of anesthesia department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2020

Primary Completion (Actual)

June 25, 2020

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

June 6, 2020

First Submitted That Met QC Criteria

June 9, 2020

First Posted (Actual)

June 11, 2020

Study Record Updates

Last Update Posted (Actual)

November 10, 2020

Last Update Submitted That Met QC Criteria

November 7, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Coronavirus Infection

Clinical Trials on prone position

3
Subscribe