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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04407468
Acronym
APRONOX
Enrollment
827
Registered
2020-05-29
Start date
2020-05-01
Completion date
2020-07-13
Last updated
2020-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ARDS, COVID, Pneumonia

Keywords

COVID, ARDS, PRONE POSITION

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.

Interventions

PROCEDUREProne position

Position of the patient in which he is face down, for an improvement in oxygenation

Sponsors

Instituto Nacional de Cancerologia de Mexico
CollaboratorOTHER
Hospital General San Juan del Rio
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Patient records with the following characteristics: * Patients over 18 years of age * Patients of both genders * Patients diagnosed with COVID-19 infection * Patients admitted to hospital * Complete file Non-inclusion criteria • Patients who do not decide to participate in the study

Exclusion criteria

• Files not found. Elimination criteria * Files with incomplete data * File with a voluntary discharge or transfer note.

Design outcomes

Primary

MeasureTime frameDescription
To analyze the relationship between the prone position and the need for orotracheal intubation.3 monthsRelationship between awake prone position and the tracheal intubation

Secondary

MeasureTime frameDescription
The impact of the prone position on the partial oxygen saturation / inspired oxygen fraction index (SaO2 / FiO2).3 monthsSee the relationship between the awake prone position and the SaO2/FiO2 INDEX

Other

MeasureTime frameDescription
Determine the free hours without the need for orotracheal intubation of patients in the prone position.3 monthsDetermine the free hours without the need for orotracheal intubation of patients in the prone position.

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026