Early Prone Position on Coronavirus Disease 2019 Pneumonia

Sponsor

Sisli Hamidiye Etfal Training and Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04427969

Collaborator

(none)

Enrollment

Location

Actual Duration (Days)

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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.

Study Design

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 :

Jun 15, 2020

Actual Primary Completion Date :

Jun 25, 2020

Actual Study Completion Date :

Jun 30, 2020

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

intensive care unit stay [up to 28 days]
the duration of icu stay day
short term mortality [up to 28 days]
mortality percent

Secondary Outcome Measures

blood gases [up to 24 hours]
partial oxygen pressure: mmhg , partial carbondiocsit pressure mmhg

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.