Ignite Creation Date:
2024-05-06 @ 2:42 PM
Last Modification Date:
2024-10-26 @ 1:36 PM
Study NCT ID:
NCT04407468
Status:
COMPLETED
Last Update Posted:
2020-07-15
First Post:
2020-05-27
Brief Title:
Awake Prone Positioning and Oxygen Therapy in Patients With COVID-19
Sponsor:
Hospital General San Juan del Rio
Organization:
Hospital General San Juan del Rio
Study Overview
Official Title:
Awake Prone Positioning and Oxygen Therapy in Patients With COVID-19 APRONOX
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APRONOX
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None