NCT04407468

Awake Prone Positioning and Oxygen Therapy in Patients With COVID-19

Awake Prone Positioning and Oxygen Therapy in Patients With COVID-19 (APRONOX)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 827 (actual)
• Sponsor: Hospital General San Juan del Rio · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The prone position strategy for patients with acute respiratory distress syndrome (ARDS) is simple and cost-effective from the first description on its use in patients with acute respiratory failure to improve hypoxemia. Different studies have investigated its safety and efficacy in various clinical settings, demonstrating that its early use in combination with non-invasive mechanical ventilation (NIV) or high-flow oxygen therapy can reduce intubation rate and mortality in ARDS. In the Coronavirus disease 2019 (COVID-19) pandemic, high-value medicine and resource optimization are critical.

Detailed description

Coronavirus disease 2019 (COVID-19) is a pandemic that has significantly challenged health systems worldwide. Due to the large number of infections around the world, the implementation of strategies to reduce the number of intubations and the need for invasive mechanical ventilation becomes important. In addition to the inability of the Mexican health system to respond, patients under invasive ventilation have not had a favorable survival outcome. Up to 97% mortality has been reported in patients requiring intubation. The exact cause of this poor prognosis is not yet known. Early recognition of hypoxemic patients could help with the results. It seems reasonable in these patients to perform procedures to improve the clinical respiratory picture before intubation in less severe cases due to the aforementioned. Prone patient placement during invasive mechanical ventilation is a widespread practice in the management of severe ARDS of other etiologies. Currently, few attempts have been made to implement the prone position in patients who spontaneously ventilate with supplemental oxygen, high-flow nasal cannulas, or noninvasive mechanical ventilation. Taking into account that it is a procedure that does not require additional infrastructure within the services and does not represent an additional cost for its implementation, it becomes a valuable tool in the context of COVID-19 where intubation is associated with high mortality and in a Additionally, there are mechanical ventilator deficits in most hospitals. This work has feasibility to be carried out because it will be carried out in critical areas that have equipment and trained personnel for it in the different shifts, in addition to having patients diagnosed with COVID-19.

Conditions

• COVID
• ARDS
• Pneumonia

Interventions

Type	Name	Description
PROCEDURE	Prone position	Position of the patient in which he is face down, for an improvement in oxygenation

Timeline

• Start date: 2020-05-01
• Primary completion: 2020-07-13
• Completion: 2020-07-13
• First posted: 2020-05-29
• Last updated: 2020-07-15

Locations

6 sites across 1 country: Mexico