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

Pneumonia Clinical Trial

— APRONOX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04407468
• Other study ID #: 1178/SESEQ-HSGJR/08-05-20/UTI
• Status: Completed
• Start date: May 1, 2020
• Est. completion date: July 13, 2020

Study information

• Verified date: July 2020
• Source: Hospital General San Juan del Rio
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 827
• Est. completion date: July 13, 2020
• Est. primary completion date: July 13, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• ARDS
• COVID
• Pneumonia

Intervention

Procedure:
• Prone position
Position of the patient in which he is face down, for an improvement in oxygenation

Locations

Country	Name	City	State
Mexico	Hospital Materno Celaya	Celaya	Guanajuato
Mexico	Hospital General de Zona 48 San PEDRO Xalpa IMSS	Estado De México
Mexico	ISSSTE Hospital Regional Merida	Mérida	Yucatan
Mexico	Hospital Fernando Quiroz Gutierrez	Mexico City
Mexico	Hospital General San Juan del Rio	Querétaro City	Queretaro
Mexico	Hospital Santo Tomas	Querétaro City	Queretaro

Sponsors (2)

Lead Sponsor	Collaborator
Hospital General San Juan del Rio	Instituto Nacional de Cancerologia de Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (10)

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 in Coronavirus Disease 2019 (COVID-19) in China: A Report of 1014 Cases. Radiology. 2020 Feb 26:200642. doi: 10.1148/radiol.2020200642. [Epub ahead — View Citation

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. — View Citation

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. — View Citation

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. Eu — View Citation

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. — View Citation

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 stu — View Citation

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 Apr 21. doi: 10.1007/s12630-020-01661-0. [Epub ahead o — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Determine the free hours without the need for orotracheal intubation of patients in the prone position.	Determine the free hours without the need for orotracheal intubation of patients in the prone position.	3 months
Primary	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	The impact of the prone position on the partial oxygen saturation / inspired oxygen fraction index (SaO2 / FiO2).	See the relationship between the awake prone position and the SaO2/FiO2 INDEX	3 months