Early Prone Position on Coronavirus Disease 2019 Pneumonia

Acute Respiratory Failure Clinical Trial

— Prone Position  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04427969
• Other study ID #: pp34
• Status: Completed
• Start date: June 15, 2020
• Est. completion date: June 30, 2020

Study information

• Verified date: November 2020
• Source: Sisli Hamidiye Etfal Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: June 30, 2020
• Est. primary completion date: June 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Coronavirus Infection
• Coronavirus Infections
• Pneumonia
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency
• Severe Acute Respiratory Syndrome

Intervention

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

Locations

Country	Name	City	State
Turkey	Sisli Etfal Research and Training Hospital	Istanbul	Marmara

Sponsors (1)

Lead Sponsor	Collaborator
Sisli Hamidiye Etfal Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15 — View Citation

Guérin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girar — View Citation

Kallet RH. A Comprehensive Review of Prone Position in ARDS. Respir Care. 2015 Nov;60(11):1660-87. doi: 10.4187/respcare.04271. Review. — View Citation

Munshi L, Del Sorbo L, Adhikari NKJ, Hodgson CL, Wunsch H, Meade MO, Uleryk E, Mancebo J, Pesenti A, Ranieri VM, Fan E. Prone Position for Acute Respiratory Distress Syndrome. A Systematic Review and Meta-Analysis. Ann Am Thorac Soc. 2017 Oct;14(Supplemen — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intensive care unit stay	the duration of icu stay day	up to 28 days
Primary	short term mortality	mortality percent	up to 28 days
Secondary	blood gases	partial oxygen pressure: mmhg , partial carbondiocsit pressure mmhg	up to 24 hours