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Completed

NCT Number: NCT04407468

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Materno Celaya, Celaya, Guanajuato, Mexico

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

prone position

Procedure

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

Primary outcomes

  1. To analyze the relationship between the prone position and the need for orotracheal intubation.

    Time frame: 3 months

    Relationship between awake prone position and the tracheal intubation

Secondary outcomes

  1. The impact of the prone position on the partial oxygen saturation / inspired oxygen fraction index (SaO2 / FiO2).

    Time frame: 3 months

    See the relationship between the awake prone position and the SaO2/FiO2 INDEX

Other outcomes

  1. Determine the free hours without the need for orotracheal intubation of patients in the prone position.

    Time frame: 3 months

    Determine the free hours without the need for orotracheal intubation of patients in the prone position.

Sponsors and collaborators

Lead sponsor

Hospital General San Juan del Rio

Network

Collaborators

  • Instituto Nacional de Cancerologia de Mexico

Registry information

Official study title

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

Acronym: APRONOX

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 29, 2020
Registry last updated
Jul 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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