NCT06076109

Early Awake Alterning Prone Positioning Combined With Non-invasive Oxygen Therapy in Patients With COVID-19.

Early Awake Alterning Prone Positioning Combined With Non-invasive Oxygen Therapy in Patients With COVID-19 (APPearl).

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Introduction: The disease caused by the new coronavirus (COVID-19) represents a pandemic with significant affectation in our country, generating critical illness in around 5% of the patients who present this disease at an international level, with the requirement of invasive mechanical ventilation being the main cause of admission to intensive care units (UTI). Objective: to evaluate the utility of using the prone position in patients with hypoxemic respiratory failure with COVID-19 who are with non-invasive oxygenation devices to reduce the need for invasive mechanical ventilation and mortality in this population. Material and methods: a controlled and randomized clinical trial will be carried out, which will include patients who come to the institution for medical attention with a confirmed or suspected diagnosis of COVID-19 with a severe presentation, hypoxemic respiratory failure, and non-existent oxygen therapy. invasive with a FiO2 contribution ≥40%. The patients enter 2 follow-up groups: an intervention group in which the prone position maneuver performed by the patient himself will be implemented, and another group where the patients will remain supine with the head of their bed between 30-60º. The demographic and clinical variables of these patients will be described. The primary outcome to be evaluated will be the proportion of patients requiring orotracheal intubation during their hospital stay. The secondary outcomes that will be evaluated will be hospital mortality, development of ARDS, and changes in oxygenation by determining SpO2 and SpO2/FiO2 on admission and at 1, 6, 12, 24, 48, and 72 hours after inclusion in the protocol. , as well as PaO2/FiO2 on admission and at 24 hours; the time interval between inclusion in the protocol and orotracheal intubation, use of non-invasive ventilatory therapies, days of hospital stay, days of stay in intensive care, days free of mechanical ventilation, development of acute organ failure during hospitalization and complications related to the treatment with the prone position.

Conditions

• COVID-19 Pneumonia

Interventions

Type	Name	Description
OTHER	Prone position	Patients who require supplemental oxygen through a non-invasive device (nasal cannulas or reservoir mask) in the prone position.
OTHER	Standard treatment	Patients who require supplemental oxygen through a non-invasive device (nasal cannulas or reservoir mask) in the supine position with the head of the bed between 30-60º.

Timeline

• Start date: 2021-03-01
• Primary completion: 2022-03-31
• Completion: 2022-04-30
• First posted: 2023-10-10
• Last updated: 2023-10-10

Locations

1 site across 1 country: Mexico