Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date May 27, 2020
First Posted Date May 29, 2020
Last Update Posted Date July 15, 2020
Actual Study Start Date May 1, 2020
Actual Primary Completion Date July 13, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 13, 2020)
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
Original Primary Outcome Measures
 (submitted: May 27, 2020)
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
Change History
Current Secondary Outcome Measures
 (submitted: May 27, 2020)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 27, 2020)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Awake Prone Positioning and Oxygen Therapy in Patients With COVID-19
Official Title Awake Prone Positioning and Oxygen Therapy in Patients With COVID-19 (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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Study population Patients diagnosed with COVID-19
Condition
  • COVID
  • ARDS
  • Pneumonia
Intervention Procedure: Prone position
Position of the patient in which he is face down, for an improvement in oxygenation
Study Groups/Cohorts COVID
Patients with or without prone position
Intervention: Procedure: Prone position
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 13, 2020)
827
Original Estimated Enrollment
 (submitted: May 27, 2020)
368
Actual Study Completion Date July 13, 2020
Actual Primary Completion Date July 13, 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Mexico
Removed Location Countries  
 
Administrative Information
NCT Number NCT04407468
Other Study ID Numbers 1178/SESEQ-HSGJR/08-05-20/UTI
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Orlando Rubén Pérez-Nieto, Hospital General San Juan del Rio
Study Sponsor Hospital General San Juan del Rio
Collaborators Instituto Nacional de Cancerologia de Mexico
Investigators
Principal Investigator: Orlando R Perez Nieto, MD Hospital General San Juan del Rio
PRS Account Hospital General San Juan del Rio
Verification Date July 2020