Early Prone Position on Coronavirus Disease 2019 Pneumonia

Completed

• Conditions: Coronavirus Infection; Acute Respiratory Failure
• Interventions: Behavioral: prone position

• Registration Number: NCT04427969
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2020-06-06
• Study First Submitted QC: 2020-06-09
• Study First Posted: 2020-06-11
• Study Start: 2020-06-15
• Primary Completion: 2020-06-25
• Study Completion: 2020-06-30
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-07
• Last Update Posted: 2020-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
EPP	prone position	patients who applied early awake prone position for treatment with conventional oxygen supply

Primary Outcome Measures

Name	Time	Method
short term mortality	up to 28 days	mortality percent
intensive care unit stay	up to 28 days	the duration of icu stay day

Secondary Outcome Measures

Name	Time	Method
blood gases	up to 24 hours	partial oxygen pressure: mmhg , partial carbondiocsit pressure mmhg

Trial Locations

Locations (1)

Sisli Etfal Research and Training Hospital; 🇹🇷 Istanbul, Marmara, Turkey