Awake Prone Position in Patients With COVID-19

• Sponsor: Brazilian Institute of Higher Education of Censa (Other)
• Overall Status: Completed
• CT.gov ID: NCT04924816
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Actual Duration (Months): 5.5
• Patients Per Site Per Month: 5.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19	Procedure: Awake prone position

Study Design

• Study Type: Observational
• Actual Enrollment: 32 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Evaluation of the Response to the Awake Prone Position in Patients With COVID-19
• Actual Study Start Date: Jul 12, 2020
• Actual Primary Completion Date: Aug 21, 2020
• Actual Study Completion Date: Dec 26, 2020

Outcome Measures

Primary Outcome Measures

1. ICU admission rate [Patients were followed up for up to 15 days of hospitalization.]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Luciano M Chicayban	Campos Dos Goytacazes	RJ	Brazil	28015150

Sponsors and Collaborators

• Brazilian Institute of Higher Education of Censa

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Luciano Matos Chicayban, Laboratório de Pesquisa em Fisioterapia Pneumofuncional e Intensiva (LAPEFIPI), Brazilian Institute of Higher Education of Censa
• ClinicalTrials.gov Identifier: NCT04924816
• Other Study ID Numbers: ISECENSA
• First Posted: Jun 14, 2021
• Last Update Posted: Jun 14, 2021
• Last Verified: Jun 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Jun 14, 2021