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

NCT ID: NCT04407468

Last Updated: 2020-07-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 827 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-01
• Study Completion Date: 2020-07-13

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.

Conditions

COVID; ARDS; Pneumonia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

COVID

Patients with or without prone position

Prone position

Intervention Type: PROCEDURE

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

Interventions

Prone position

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

Intervention Type: PROCEDURE

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

Exclusion Criteria

• Files not found.

Elimination criteria

• Files with incomplete data
• File with a voluntary discharge or transfer note.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Instituto Nacional de Cancerologia de Mexico

OTHER

Sponsor Role: collaborator

Hospital General San Juan del Rio

NETWORK

Sponsor Role: lead

Responsible Party

Orlando Rubén Pérez-Nieto

Dr. Orlando Ruben Perez Nieto

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Orlando R Perez Nieto, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital General San Juan del Rio

Locations

Hospital Materno Celaya

Celaya, Guanajuato, Mexico

Hospital Santo Tomas

Querétaro City, Querétaro, Mexico

Hospital General San Juan del Rio

Querétaro City, Querétaro, Mexico

ISSSTE Hospital Regional Merida

Mérida, Yucatán, Mexico

Hospital General de Zona 48 San PEDRO Xalpa IMSS

Estado de México, , Mexico

Hospital Fernando Quiroz Gutierrez

Mexico City, , Mexico

Countries

Mexico

References

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.

Reference Type: BACKGROUND

PMID: 32505599 (View on PubMed)

Valter C, Christensen AM, Tollund C, Schonemann NK. Response to the prone position in spontaneously breathing patients with hypoxemic respiratory failure. Acta Anaesthesiol Scand. 2003 Apr;47(4):416-8. doi: 10.1034/j.1399-6576.2003.00088.x.

Reference Type: RESULT

PMID: 12694139 (View on PubMed)

Scaravilli V, Grasselli G, Castagna L, Zanella A, Isgro 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.

Reference Type: RESULT

PMID: 26271685 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32000806 (View on PubMed)

Perez-Nieto OR, Guerrero-Gutierrez MA, Deloya-Tomas E, Namendys-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. No abstract available.

Reference Type: RESULT

PMID: 32204726 (View on PubMed)

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. No abstract available.

Reference Type: RESULT

PMID: 32189136 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32320506 (View on PubMed)

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. No abstract available.

Reference Type: RESULT

PMID: 32319029 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32289051 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32101510 (View on PubMed)

Perez-Nieto OR, Escarraman-Martinez D, Guerrero-Gutierrez MA, Zamarron-Lopez EI, Mancilla-Galindo J, Kammar-Garcia A, Martinez-Camacho MA, Deloya-Tomas E, Sanchez-Diaz JS, Macias-Garcia LA, Soriano-Orozco R, Cruz-Sanchez G, Salmeron-Gonzalez JD, Toledo-Rivera MA, Mata-Maqueda I, Morgado-Villasenor LA, Martinez-Mazariegos JJ, Flores Ramirez R, Medina-Estrada JL, Namendys-Silva SA; APRONOX Group. Awake prone positioning and oxygen therapy in patients with COVID-19: the APRONOX study. Eur Respir J. 2022 Feb 24;59(2):2100265. doi: 10.1183/13993003.00265-2021. Print 2022 Feb.

Reference Type: DERIVED

PMID: 34266942 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

1178/SESEQ-HSGJR/08-05-20/UTI

Identifier Type: -

Identifier Source: org_study_id