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

• 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

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

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 *

• Wan S, Li M, Ye Z, Yang C, Cai Q, Duan S, Song B. CT Manifestations and Clinical Characteristics of 1115 Patients with Coronavirus Disease 2019 (COVID-19): A Systematic Review and Meta-analysis. Acad Radiol. 2020 Jul;27(7):910-921. doi: 10.1016/j.acra.2020.04.033. Epub 2020 May 5.
• Valter C, Christensen AM, Tollund C, Schønemann NK. Response to the prone position in spontaneously breathing patients with hypoxemic respiratory failure. Acta Anaesthesiol Scand. 2003 Apr;47(4):416-8.
• Scaravilli V, Grasselli G, Castagna L, Zanella A, Isgrò S, Lucchini A, Patroniti N, Bellani G, Pesenti A. Prone positioning improves oxygenation in spontaneously breathing nonintubated patients with hypoxemic acute respiratory failure: A retrospective study. J Crit Care. 2015 Dec;30(6):1390-4. doi: 10.1016/j.jcrc.2015.07.008. Epub 2015 Jul 16.
• Ding L, Wang L, Ma W, He H. Efficacy and safety of early prone positioning combined with HFNC or NIV in moderate to severe ARDS: a multi-center prospective cohort study. Crit Care. 2020 Jan 30;24(1):28. doi: 10.1186/s13054-020-2738-5.
• Pérez-Nieto OR, Guerrero-Gutiérrez MA, Deloya-Tomas E, Ñamendys-Silva SA. Prone positioning combined with high-flow nasal cannula in severe noninfectious ARDS. Crit Care. 2020 Mar 23;24(1):114. doi: 10.1186/s13054-020-2821-y.
• Sun Q, Qiu H, Huang M, Yang Y. Lower mortality of COVID-19 by early recognition and intervention: experience from Jiangsu Province. Ann Intensive Care. 2020 Mar 18;10(1):33. doi: 10.1186/s13613-020-00650-2.
• Caputo ND, Strayer RJ, Levitan R. Early Self-Proning in Awake, Non-intubated Patients in the Emergency Department: A Single ED's Experience During the COVID-19 Pandemic. Acad Emerg Med. 2020 May;27(5):375-378. doi: 10.1111/acem.13994.
• Slessarev M, Cheng J, Ondrejicka M, Arntfield R; Critical Care Western Research Group. Patient self-proning with high-flow nasal cannula improves oxygenation in COVID-19 pneumonia. Can J Anaesth. 2020 Sep;67(9):1288-1290. doi: 10.1007/s12630-020-01661-0. Epub 2020 Apr 21.
• Lomoro P, Verde F, Zerboni F, Simonetti I, Borghi C, Fachinetti C, Natalizi A, Martegani A. COVID-19 pneumonia manifestations at the admission on chest ultrasound, radiographs, and CT: single-center study and comprehensive radiologic literature review. Eur J Radiol Open. 2020;7:100231. doi: 10.1016/j.ejro.2020.100231. Epub 2020 Apr 4.
• Ai T, Yang Z, Hou H, Zhan C, Chen C, Lv W, Tao Q, Sun Z, Xia L. Correlation of Chest CT and RT-PCR Testing for Coronavirus Disease 2019 (COVID-19) in China: A Report of 1014 Cases. Radiology. 2020 Aug;296(2):E32-E40. doi: 10.1148/radiol.2020200642. Epub 2020 Feb 26.

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

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