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

H

Hospital General San Juan del Rio

Status

Completed

Conditions

COVID
Pneumonia
ARDS

Treatments

Procedure: Prone position

Study type

Observational

Funder types

Other
NETWORK

Identifiers

NCT04407468
1178/SESEQ-HSGJR/08-05-20/UTI

Details and patient eligibility

About

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.

Full 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.

Enrollment

827 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

827 participants in 1 patient group

COVID
Description:
Patients with or without prone position
Treatment:
Procedure: Prone position

Trial documents
1

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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