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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04407468
Recruitment Status : Completed
First Posted : May 29, 2020
Last Update Posted : July 15, 2020
Sponsor:
Collaborator:
Instituto Nacional de Cancerologia de Mexico
Information provided by (Responsible Party):
Orlando Rubén Pérez-Nieto, Hospital General San Juan del Rio

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.

Condition or disease Intervention/treatment
COVID ARDS Pneumonia Procedure: Prone position

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.

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Study Type : Observational
Actual Enrollment : 827 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Awake Prone Positioning and Oxygen Therapy in Patients With COVID-19 (APRONOX)
Actual Study Start Date : May 1, 2020
Actual Primary Completion Date : July 13, 2020
Actual Study Completion Date : July 13, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Group/Cohort Intervention/treatment
COVID
Patients with or without prone position
Procedure: Prone position
Position of the patient in which he is face down, for an improvement in oxygenation




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Study population Patients diagnosed with COVID-19
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04407468


Locations
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Mexico
Hospital Materno Celaya
Celaya, Guanajuato, Mexico, 38096
Hospital Santo Tomas
Querétaro City, Queretaro, Mexico, 76116
Hospital General San Juan del Rio
Querétaro City, Queretaro, Mexico, 76804
ISSSTE Hospital Regional Merida
Mérida, Yucatan, Mexico, 97219
Hospital General de Zona 48 San PEDRO Xalpa IMSS
Estado De México, Mexico, 02710
Hospital Fernando Quiroz Gutierrez
Mexico City, Mexico, 01140
Sponsors and Collaborators
Hospital General San Juan del Rio
Instituto Nacional de Cancerologia de Mexico
Investigators
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Principal Investigator: Orlando R Perez Nieto, MD Hospital General San Juan del Rio
  Study Documents (Full-Text)

Documents provided by Orlando Rubén Pérez-Nieto, Hospital General San Juan del Rio:
Study Protocol  [PDF] May 10, 2020

Publications of Results:

Other Publications:
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Responsible Party: Orlando Rubén Pérez-Nieto, Dr. Orlando Ruben Perez Nieto, Hospital General San Juan del Rio
ClinicalTrials.gov Identifier: NCT04407468    
Other Study ID Numbers: 1178/SESEQ-HSGJR/08-05-20/UTI
First Posted: May 29, 2020    Key Record Dates
Last Update Posted: July 15, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Orlando Rubén Pérez-Nieto, Hospital General San Juan del Rio:
COVID
ARDS
PRONE POSITION
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections