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:
Hospital General San Juan del Rio
Collaborator:
Instituto Nacional de Cancerologia de Mexico
Information provided by (Responsible Party):
Orlando Rubén Pérez-Nieto, Hospital General San Juan del Rio
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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 |
| 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
| 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 :
- 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 :
- 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:
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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
| 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
| 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:
Documents provided by Orlando Rubén Pérez-Nieto, Hospital General San Juan del Rio:
Study Protocol [PDF] May 10, 2020
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
| 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:
|
Pneumonia Respiratory Tract Infections Infections Lung Diseases Respiratory Tract Diseases |