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

NCT04407468 | Completed

• 1 other identifier: 1178/SESEQ-HSGJR/08-05-20/UTI
• Study Type: observational
• Target: 827
• Locations: 1 country
• Sites: 6

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.

Conditions

COVID; ARDS; Pneumonia

Keywords

COVID; ARDS; PRONE POSITION

Outcome Measures

Primary Outcomes (1)

• To analyze the relationship between the prone position and the need for orotracheal intubation.

  Relationship between awake prone position and the tracheal intubation

  3 months

Secondary Outcomes (1)

• The impact of the prone position on the partial oxygen saturation / inspired oxygen fraction index (SaO2 / FiO2).

  3 months

Other Outcomes (1)

• Determine the free hours without the need for orotracheal intubation of patients in the prone position.

  3 months

Study Arms (1)

COVID

Patients with or without prone position

Procedure: Prone position

Interventions

Prone position PROCEDURE

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

COVID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population Patients diagnosed with COVID-19

You may qualify if:

• 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

You may not qualify if:

• Files not found.
• Elimination criteria
• Files with incomplete data
• File with a voluntary discharge or transfer note.

Sponsors & Collaborators

• Hospital General San Juan del Rio: lead
• Instituto Nacional de Cancerologia de Mexico: collaborator

Study Sites (6)

Hospital Materno Celaya

Celaya, Guanajuato, 38096, Mexico

Location

Hospital Santo Tomas

Querétaro City, Querétaro, 76116, Mexico

Location

Hospital General San Juan del Rio

Querétaro City, Querétaro, 76804, Mexico

Location

ISSSTE Hospital Regional Merida

Mérida, Yucatán, 97219, Mexico

Location

Hospital General de Zona 48 San PEDRO Xalpa IMSS

Estado de México, 02710, Mexico

Location

Hospital Fernando Quiroz Gutierrez

Mexico City, 01140, Mexico

Location

Related Publications (11)

• 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.

  PMID: 32505599 BACKGROUND

• 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.

  PMID: 12694139 RESULT

• 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.

  PMID: 26271685 RESULT

• 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.

  PMID: 32000806 RESULT

• 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.

  PMID: 32204726 RESULT

• 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.

  PMID: 32189136 RESULT

• 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.

  PMID: 32320506 RESULT

• 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.

  PMID: 32319029 RESULT

• 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.

  PMID: 32289051 RESULT

• 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.

  PMID: 32101510 RESULT

• 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.

  PMID: 34266942 DERIVED

MeSH Terms

Conditions

Pneumonia

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Orlando R Perez Nieto, MD

  Hospital General San Juan del Rio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Orlando Ruben Perez Nieto

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: May 29, 2020
• Study Start: May 1, 2020
• Primary Completion: July 13, 2020
• Study Completion: July 13, 2020
• Last Updated: July 15, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

ME (6)