Mechanical Ventilation Epidemiology in Argentina.

Respiration, Artificial Clinical Trial

— EpVAr2019  

Official title:

Mechanical Ventilation Epidemiology in Argentina. EpVAr Multicenter Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04107467
• Other study ID #: EpVAr
• Status: Completed
• Start date: September 9, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: October 2020
• Source: Argentinian Intensive Care Society
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

How is the epidemiology of mechanically ventilated patients in the intensive care units of Argentina?

Description:

Mechanical ventilation is an indispensable tool in life support and one of the interventions that characterizes intensive care units (ICU). Epidemiological studies have allowed us to improve knowledge and optimize the treatment of patients with acute respiratory failure. In Latin America the epidemiological data of mechanical ventilation is poor. Primary goal of this national, observational, prospective, multicentric epidemiological study: to analyze the survival and describe epidemiological features of patients receiving mechanical ventilation in the Intensive Care Units of Argentina.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 950
• Est. completion date: December 31, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ICU patients requiring Mechanical Ventilation at least for 12 hours
• ICU patients who initiate Mechanical Ventilation in the Operation Room or the Emergency Room
• ICU patients who initiate Mechanical Ventilation in other institution.

Exclusion Criteria:

• Patients under 18 years old
• Patients in Pediatric ICU
• Patients in Coronary ICU
• Patients without requirements of Mechanical Ventilation
• Patients who have been discharged from ICU and re-enter during the enrollment period

Related Conditions & MeSH terms

• Epidemiology
• Respiration, Artificial

Locations

Country	Name	City	State
Argentina	Hospital Fiorito	Avellaneda
Argentina	Sanatorio Norte SRL	Avellaneda
Argentina	Hospital Italiano Regional del Sur	Bahía Blanca
Argentina	Hospital privado Dr Raul Matera	Bahía Blanca
Argentina	Hospital Area Programa Bariloche "Ramón Carrillo"	Bariloche
Argentina	Cemic H.U. Pombo	Buenos Aires
Argentina	CEMIC H.U. Saavedra	Buenos Aires
Argentina	Cínica de los Virreyes	Buenos Aires
Argentina	Clínica Adventista Belgrano	Buenos Aires
Argentina	Clínica Bazterrica	Buenos Aires
Argentina	Clinica La Sagrada Familia	Buenos Aires
Argentina	Clínica Pasteleros	Buenos Aires
Argentina	Clinica y Maternidad Suizo Argentina	Buenos Aires
Argentina	Clinica Zabala	Buenos Aires
Argentina	Complejo Medico de la Policia Federal Churruca Visca	Buenos Aires
Argentina	Hospital Alemán	Buenos Aires
Argentina	Hospital Alvarez	Buenos Aires
Argentina	Hospital de Clínicas José de San Martín	Buenos Aires
Argentina	Hospital de Rehabilitación Respiratoria María Ferrer	Buenos Aires
Argentina	Hospital de Trauma y Emergencia Dr. Federico Abete	Buenos Aires
Argentina	Hospital Dr D. Velez Sarsfield	Buenos Aires
Argentina	Hospital Fernandez	Buenos Aires
Argentina	Hospital Francisco Javier Muñiz	Buenos Aires
Argentina	Hospital Generall de Agudos Dr Cosme Argerich	Buenos Aires
Argentina	Hospital Italiano de Buenos Aires	Buenos Aires
Argentina	Hospital Naval Pedro Mallo	Buenos Aires
Argentina	Hospital Piñero	Buenos Aires
Argentina	Hospital Ramos Mejía	Buenos Aires
Argentina	Hospital Santojanni	Buenos Aires
Argentina	Hospital Santojanni SRS	Buenos Aires
Argentina	Hospital Sirio Libanes	Buenos AIres
Argentina	Hospital Universitario Fundación Favaloro-UTI 1	Buenos Aires
Argentina	Hospital Universitario Fundación Favaloro-UTI 2	Buenos Aires
Argentina	Hospital Universitario UAI	Buenos AIres
Argentina	HZGA Dr alberto Balestrini	Buenos Aires
Argentina	Instituto Argentino de Diagnostico y Tratamiento	Buenos Aires
Argentina	Instituto de Trasplante y Alta Complejidad	Buenos Aires
Argentina	Instituto Lanari	Buenos Aires
Argentina	Instituto Médico de Alta Complejidad	Buenos Aires
Argentina	Sanatorio Anchorena	Buenos Aires
Argentina	Sanatorio Colegiales	Buenos Aires
Argentina	Sanatorio de la Trinidad Mitre	Buenos Aires
Argentina	Sanatorio de la Trinidad Palermo	Buenos Aires
Argentina	Sanatorio de los Arcos	Buenos Aires
Argentina	Sanatorio Finochietto	Buenos Aires
Argentina	Sanatorio Mater Dei	Buenos Aires
Argentina	Sanatorio Otamendi	Buenos Aires
Argentina	Htal de alta complejidad cuenca alta SAMIC	Cañuelas
Argentina	Hospital Municipal de Agudos Dr. Pedro Ecay	Carmen de Patagones
Argentina	Hospital Municipal del Carmen de Chacabuco	Chacabuco
Argentina	Hospital de Chivilcoy	Chivilcoy
Argentina	Policlinico Modelo Cipolletti	Cipolletti
Argentina	Hospital Carrillo de Ciudadela	Ciudadela
Argentina	Clinica del Valle	Comodoro Rivadavia
Argentina	Hospital Regional V Sanguinetti	Comodoro Rivadavia
Argentina	Hospital Zonal Alvear	Comodoro Rivadavia
Argentina	Hospital Justo José de Urquiza	Concepción Del Uruguay
Argentina	Clinica Chutro	Cordoba
Argentina	Clínica Santa Maria	Cordoba
Argentina	Clínica Universitaria Reina Fabiola	Cordoba
Argentina	Hospital Italiano	Cordoba
Argentina	Hospital Misericordia Nuevo Siglo	Cordoba
Argentina	Hospital Privado de Cordoba	Cordoba
Argentina	Hospital San Roque	Cordoba
Argentina	Sanatorio Allende Cerro	Cordoba
Argentina	Sanatorio Allende Nueva Córdoba	Cordoba
Argentina	Sanatorio Privado del Intenterio SRL	Cordoba
Argentina	Hospital Córdoba	Córdoba
Argentina	Hospital Municipal Principe de Asturias	Córdoba
Argentina	Hospital Publico Provincial de la Ciudad de Córdoba	Córdoba
Argentina	Hospital Escuela Gral José de San Martín	Corrientes
Argentina	Instituto de Cardiologia Juana Francisca Cabral	Corrientes
Argentina	Hospital Central de Formosa	Formosa
Argentina	Sanatorio Juan XXIII	General Roca
Argentina	Hospital Simplemente Evita	González Catán
Argentina	Hospital Eva Peron	Granadero Baigorria
Argentina	Hospital Profesor Dr Luis Guemes	Haedo
Argentina	Clínica la pequeña Familia	Junín
Argentina	Clínica Argentina	La Pampa
Argentina	HIEA y C "San Juan de Dios"	La Plata
Argentina	HIGA San Martín de La Plata	La Plata
Argentina	HIGA San Roque	La Plata
Argentina	Hospital español	La Plata
Argentina	Hospital Italiano de La Plata	La Plata
Argentina	Instituto Médico Platense	La Plata
Argentina	Ipensa	La Plata
Argentina	Sanatorio Adventista del Plata	La Plata
Argentina	HIGA Luisa Cravenna de Gandulfo	Lomas De Zamora
Argentina	Clinica 25 de Mayo	Mar Del Plata
Argentina	HIGA Dr Oscar Alende	Mar Del Plata
Argentina	Clinica Santa Maria	Mendoza
Argentina	Clinica Sociedad Española de Socorros Mutuos de Mendoza	Mendoza
Argentina	Hospital Central	Mendoza
Argentina	Hospital del Carmen	Mendoza
Argentina	Hospital Luis C Lagomaggiore	Mendoza
Argentina	Hospital Santa Isabel de Hungría	Mendoza
Argentina	Hospital Eva Perón	Merlo
Argentina	Clínica Monte Grande	Monte Grande
Argentina	HZGA Mariano y Luciano de la Vega	Moreno
Argentina	Hospital de Morón	Morón
Argentina	Hospital Nacional A. Posadas	Morón
Argentina	Sanatorio Clínica Modelo de Moron	Morón
Argentina	Hospital Municipal Emilio Ferreyra	Necochea
Argentina	Clinica CMIC	Neuquén
Argentina	Clínica Pasteur	Neuquén
Argentina	Clínica San Agustín	Neuquén
Argentina	Clinica Olivos	Olivos
Argentina	Hospital Militar Regional de Parana	Paraná
Argentina	HIGA San Jose de Pergamino	Pergamino
Argentina	Hospital Universitario Austral	Pilar
Argentina	Hospital Municipal de Pinamar	Pinamar
Argentina	Hospital Escuela de Agudos Dr. Ramon Madariaga	Posadas
Argentina	Hospital Público Autogestión SAMIC el Dorado	Posadas
Argentina	Hospital de Autogestión Samic Iguazú	Puerto Iguazu
Argentina	Sanatorio de la Ciudad S.R.L	Puerto Madryn
Argentina	Sanatorio de la Trinidad Quilmes	Quilmes
Argentina	Sanatorio de la Trinidad Ramos Mejía	Ramos Mejía
Argentina	Hospital central Reconquista	Reconquista
Argentina	Hospital Dr. Julio Perrando	Resistencia
Argentina	Hospital Español de Rosario	Rosario
Argentina	Policlinico PAMI 1	Rosario
Argentina	Sanatorio Mapaci	Rosario
Argentina	Sanatorio Parque	Rosario
Argentina	Hospital del Sr. del Milagro	Salta
Argentina	Hospital Papa Francisco	Salta
Argentina	Hospital Publico de Auogestión Dr Arturo Oñativia	Salta
Argentina	HPGD San Bernardo	Salta
Argentina	HIGA Petrona V. de Cordero de San Fernando	San Fernando
Argentina	Instituto Medico de la Comunidad	San Fernando Del Valle De Catamarca
Argentina	Sanatorio de la Trinidad San Isidro	San Isidro
Argentina	Sanatorio Las Lomas	San Isidro
Argentina	Centro de Cuidados Intensivos	San Juan
Argentina	Clinica Santa Clara de la Porvincia de San Juan	San Juan
Argentina	Hospital Dr Guillermo Rawson	San Juan
Argentina	Hospital Público descentralizado Dr. Marcial Vicente Quiroga.	San Juan
Argentina	Hospital Italiano de San Justo	San Justo
Argentina	Hospital Madre Catalina	San Luis
Argentina	Hospital San Luis	San Luis
Argentina	Hospital Centro de Salud Zenón Santillán	San Miguel De Tucumán
Argentina	Hospital de clínica Presidente Doctor Nicolas Avellaneda	San Miguel De Tucumán
Argentina	Sanatorio Lavalle	San Salvador De Jujuy
Argentina	Sanatorio Nuestra Sra del Rosario	San Salvador De Jujuy
Argentina	Htal Cullen de Santa Fe	Santa Fe
Argentina	Sanatorio Español	Santa Fe
Argentina	Sanatorio Santa Fe	Santa Fe
Argentina	Sanatorio Santa Fé	Santa Fe
Argentina	Centro Integral de Salud Banda	Santiago Del Estero
Argentina	Hospital regional Dr. Ramon Carrillo	Santiago Del Estero
Argentina	Hospital Ramón Santamarina	Tandil
Argentina	Sanatorio Juncal	Temperley
Argentina	Hospital Regional de Ushuaia	Ushuaia
Argentina	Hospital Nodal Dr. Alejandro Gutierrez	Venado Tuerto
Argentina	Hospital Houssay	Vicente López
Argentina	Hospital Artemides Zatti	Viedma

Sponsors (1)

Lead Sponsor	Collaborator
Argentinian Intensive Care Society

Country where clinical trial is conducted

Argentina, 

References & Publications (17)

Acute Respiratory Distress Syndrome Network, Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress sy — View Citation

Azevedo LC, Park M, Salluh JI, Rea-Neto A, Souza-Dantas VC, Varaschin P, Oliveira MC, Tierno PF, dal-Pizzol F, Silva UV, Knibel M, Nassar AP Jr, Alves RA, Ferreira JC, Teixeira C, Rezende V, Martinez A, Luciano PM, Schettino G, Soares M; ERICC (Epidemiolo — View Citation

Brochard L, Rauss A, Benito S, Conti G, Mancebo J, Rekik N, Gasparetto A, Lemaire F. Comparison of three methods of gradual withdrawal from ventilatory support during weaning from mechanical ventilation. Am J Respir Crit Care Med. 1994 Oct;150(4):896-903. — View Citation

Chanques G, Jaber S, Barbotte E, Violet S, Sebbane M, Perrigault PF, Mann C, Lefrant JY, Eledjam JJ. Impact of systematic evaluation of pain and agitation in an intensive care unit. Crit Care Med. 2006 Jun;34(6):1691-9. — View Citation

Charlson ME, Charlson RE, Peterson JC, Marinopoulos SS, Briggs WM, Hollenberg JP. The Charlson comorbidity index is adapted to predict costs of chronic disease in primary care patients. J Clin Epidemiol. 2008 Dec;61(12):1234-1240. doi: 10.1016/j.jclinepi. — View Citation

Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. — View Citation

Devlin JW, Skrobik Y, Gélinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress — View Citation

Esteban A, Alía I, Gordo F, Fernández R, Solsona JF, Vallverdú I, Macías S, Allegue JM, Blanco J, Carriedo D, León M, de la Cal MA, Taboada F, Gonzalez de Velasco J, Palazón E, Carrizosa F, Tomás R, Suarez J, Goldwasser RS. Extubation outcome after sponta — View Citation

Esteban A, Anzueto A, Frutos F, Alía I, Brochard L, Stewart TE, Benito S, Epstein SK, Apezteguía C, Nightingale P, Arroliga AC, Tobin MJ; Mechanical Ventilation International Study Group. Characteristics and outcomes in adult patients receiving mechanical — View Citation

Esteban A, Frutos F, Tobin MJ, Alía I, Solsona JF, Valverdú I, Fernández R, de la Cal MA, Benito S, Tomás R, et al. A comparison of four methods of weaning patients from mechanical ventilation. Spanish Lung Failure Collaborative Group. N Engl J Med. 1995 — View Citation

Esteban A, Frutos-Vivar F, Muriel A, Ferguson ND, Peñuelas O, Abraira V, Raymondos K, Rios F, Nin N, Apezteguía C, Violi DA, Thille AW, Brochard L, González M, Villagomez AJ, Hurtado J, Davies AR, Du B, Maggiore SM, Pelosi P, Soto L, Tomicic V, D'Empaire — View Citation

Fàbregas N, Ewig S, Torres A, El-Ebiary M, Ramirez J, de La Bellacasa JP, Bauer T, Cabello H. Clinical diagnosis of ventilator associated pneumonia revisited: comparative validation using immediate post-mortem lung biopsies. Thorax. 1999 Oct;54(10):867-73 — View Citation

Gélinas C, Johnston C. Pain assessment in the critically ill ventilated adult: validation of the Critical-Care Pain Observation Tool and physiologic indicators. Clin J Pain. 2007 Jul-Aug;23(6):497-505. — View Citation

Le Gall JR, Lemeshow S, Saulnier F. A new Simplified Acute Physiology Score (SAPS II) based on a European/North American multicenter study. JAMA. 1993 Dec 22-29;270(24):2957-63. Erratum in: JAMA 1994 May 4;271(17):1321. — View Citation

Protti A, Cressoni M, Santini A, Langer T, Mietto C, Febres D, Chierichetti M, Coppola S, Conte G, Gatti S, Leopardi O, Masson S, Lombardi L, Lazzerini M, Rampoldi E, Cadringher P, Gattinoni L. Lung stress and strain during mechanical ventilation: any safe threshold? Am J Respir Crit Care Med. 2011 May 15;183(10):1354-62. doi: 10.1164/rccm.201010-1757OC. Epub 2011 Feb 4. Erratum in: Am J Respir Crit Care Med. 2012 Jan 1;185(1):115. — View Citation

Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International C — View Citation

Tomicic V, Espinoza M, Andresen M, Molina J, Calvo M, Ugarte H, Godoy J, Gálvez S, Maurelia JC, Delgado I, Esteban A; Grupo Chileno para el Estudio de la Ventilación Mecánica. [Characteristics and factors associated with mortality in patients receiving me — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival in the ICU	"Survival in the ICU" will be measured as YES or NO at day 28 after the enrollment.	Up to 28 days after the enrollment
Secondary	Main reason of Invasive Mechanical Ventilation	Acute respiratory failure in patient with chronic respiratory failure: A)Chronic Obstructive Pulmonary Disease, B) Asthma, C) Other Chronic Obstructive Pulmonary Disease (Idiopathic pulmonary fibrosis, Cystic Fibrosis, Interstitial disease).; Acute Respiratory Failure: A) Acute Respiratory Distress Syndrome, B) Postoperative, C) Acute Heart Failure, D) Aspiration, E) Pneumonia, F) Sepsis, G) Trauma, H) Cardiac arrest, I)Others.; Coma: A)Metabolic, B)Overdose, Intoxication, C)Stroke, D)Brain trauma.; Neuromuscular disease	1 day
Secondary	Ventilatory Modes and setting	Volume Control Ventilation, Pressure Control Ventilation, Pressure Support Ventilation, Synchronized Intermittent Mandatory Ventilation, Other (Proportional Assist Ventilation, Neurally Adjusted Ventilation, Airway Pressure Release Ventilation)	Up to 10 days
Secondary	Tidal Volume	Set tidal volume in mililiters	Up to 10 days
Secondary	Weaning and mortality	Weaning characteristics and outcome of the patient in terms of mortality.	Up to 28 days
Secondary	Noninvasive ventilation during weaning and mortality	The use of NIV during weaning and the outcome of the patient in terms of mortality	Up to 28 days
Secondary	Incidence of delirium	Delirium measured with the CAM- ICU.	Up to 28 days
Secondary	Incidence of ICU acquired weakness	Periphereal muscle weakness measured with MRC defined as a total value of less than 48 points.	Up to 28 days
Secondary	Incidence of tracheostomy	Presence of tracheostomy	Up to 28 days
Secondary	Sedation and analgesia in mechanical ventilation	Implementation of sedation and analgesia during the period of mechanical ventilation.	Up to 28 days
Secondary	Peak Pressure	Monitored Peak Pressure in centimeters of water	Up to 10 days
Secondary	Plateau Pressure	Monitored Plateau Pressure in centimeters of water	Up to 10 days
Secondary	Applied PEEP	Set PEEP in centimeters of water	Up to 10 days
Secondary	Total PEEP	Monitored total PEEP in centimeters of water	Up to 10 days
Secondary	Driving Pressure	Monitored Driving Pressure in centimeters of water as the difference between Total PEEP and Plateau Pressure in centimeters of water	Up to 10 days

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