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Completed

NCT Number: NCT04427969

Early Prone Position on 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sisli Etfal Research and Training Hospital

Istanbul, Marmara, 34400, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prone position

Behavioral

to lay in prone position at least 12 hour in a day at ICU

Primary outcomes

  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 outcomes

  1. blood gases

    Time frame: up to 24 hours

    partial oxygen pressure: mmhg , partial carbondiocsit pressure mmhg

Sponsors and collaborators

Lead sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Other

Registry information

Official study title

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

Acronym: Prone Position

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 11, 2020
Registry last updated
Nov 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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