Awake Prone Position in Patients With COVID-19

NCT04924816 | Completed DMC

• 1 other identifier: ISECENSA
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• 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.

Interventions

Awake prone position PROCEDURE

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

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a confirmed diagnosis of COVID-19, spontaneously ventilating, dependent on supplemental oxygen.

You may not qualify if:

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

Sponsors & Collaborators

• Brazilian Institute of Higher Education of Censa: lead

Study Sites (1)

Luciano M Chicayban

Campos dos Goytacazes, Rio de Janeiro, 28015150, Brazil

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Laboratório de Pesquisa em Fisioterapia Pneumofuncional e Intensiva (LAPEFIPI)

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: June 14, 2021
• Study Start: July 12, 2020
• Primary Completion: August 21, 2020
• Study Completion: December 26, 2020
• Last Updated: June 14, 2021

Record last verified: 2021-06

Locations

BR (1)