Awake Prone Position in Patients With COVID-19

Covid19 Clinical Trial

Official title:

Evaluation of the Response to the Awake Prone Position in Patients With COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04924816
• Other study ID #: ISECENSA
• Status: Completed
• Start date: July 12, 2020
• Est. completion date: December 26, 2020

Study information

• Verified date: June 2021
• Source: Brazilian Institute of Higher Education of Censa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Although prone position is widely used in awake patients with COVID-19 associated with supplemental oxygenation, high flow nasal catheter, or noninvasive ventilation, few studies are attesting to its real benefits on physiological variables or intubation rate. Awake patients dependent on supplemental oxygen may have different responses to PP about peripheral oxygen saturation, heart rate, and respiratory rate. Such responses may be permanent, transient, or even absent. We believe that the response to PP can be a predictor of the need for admission to the ICU. This study aimed to evaluate the acute effects of different types of response to the prone position in patients awake with COVID-19.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 26, 2020
• Est. primary completion date: August 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

Inclusion Criteria: patients with a confirmed diagnosis of COVID-19, through tests based on PCR and chest tomography with suggestive findings, spontaneously ventilating, dependent on supplemental oxygen. The study included patients with: (1) age = 18 years, (2) peripheral oxygen saturation less than 92% under supplemental oxygen administration equal to or greater than 6 L / min through a nasal catheter or reservoir mask; (3) no use of NIV or high-flow nasal catheter; (4) continuous monitoring with pulse oximeter; (5) mental status that allowed to follow the instructions; and (6) able to tolerate PP with minimal assistance.

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Exclusion Criteria:

• hemodynamic instability, severe obesity, or who were unable to tolerate and cooperate with the performance of PP

Related Conditions & MeSH terms

• Covid19

Intervention

Procedure:
• Awake prone position
The prone position in awake patients consists of asking the patient to voluntarily change to prone position, in a swimmer's posture

Locations

Country	Name	City	State
Brazil	Luciano M Chicayban	Campos Dos Goytacazes	RJ

Sponsors (1)

Lead Sponsor	Collaborator
Brazilian Institute of Higher Education of Censa

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ICU admission rate	The criteria defined for admission to the ICU included maintenance of SpO2 below 90% with oxygen flow at 15 L / min, RF greater than 30 incursions per minute, reduced level of consciousness, or clinical signs of persistent increase in respiratory work, such as paradoxical ventilatory pattern.	Patients were followed up for up to 15 days of hospitalization.