EpVAr2019: Mechanical Ventilation Epidemiology in Argentina.
Sponsor
Argentinian Intensive Care Society (Other)
Overall Status
Completed
CT.gov ID
NCT04107467
Collaborator
(none)
950
154
3.7
6.2
1.7
Study Details
Study Description
Brief Summary
How is the epidemiology of mechanically ventilated patients in the intensive care units of Argentina?
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Detailed 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.
Study Design
Study Type:
Observational [Patient Registry]
Actual Enrollment
:
950 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Mechanical Ventilation Epidemiology in Argentina. EpVAr Multicenter Study.
Actual Study Start Date
:
Sep 9, 2019
Actual Primary Completion Date
:
Nov 30, 2019
Actual Study Completion Date
:
Dec 31, 2019
Outcome Measures
Primary Outcome Measures
- Survival in the ICU [Up to 28 days after the enrollment]
"Survival in the ICU" will be measured as YES or NO at day 28 after the enrollment.
Secondary Outcome Measures
- Main reason of Invasive Mechanical Ventilation [1 day]
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
- Ventilatory Modes and setting [Up to 10 days]
Volume Control Ventilation, Pressure Control Ventilation, Pressure Support Ventilation, Synchronized Intermittent Mandatory Ventilation, Other (Proportional Assist Ventilation, Neurally Adjusted Ventilation, Airway Pressure Release Ventilation)
- Tidal Volume [Up to 10 days]
Set tidal volume in mililiters
- Weaning and mortality [Up to 28 days]
Weaning characteristics and outcome of the patient in terms of mortality.
- Noninvasive ventilation during weaning and mortality [Up to 28 days]
The use of NIV during weaning and the outcome of the patient in terms of mortality
- Incidence of delirium [Up to 28 days]
Delirium measured with the CAM- ICU.
- Incidence of ICU acquired weakness [Up to 28 days]
Periphereal muscle weakness measured with MRC defined as a total value of less than 48 points.
- Incidence of tracheostomy [Up to 28 days]
Presence of tracheostomy
- Sedation and analgesia in mechanical ventilation [Up to 28 days]
Implementation of sedation and analgesia during the period of mechanical ventilation.
- Peak Pressure [Up to 10 days]
Monitored Peak Pressure in centimeters of water
- Plateau Pressure [Up to 10 days]
Monitored Plateau Pressure in centimeters of water
- Applied PEEP [Up to 10 days]
Set PEEP in centimeters of water
- Total PEEP [Up to 10 days]
Monitored total PEEP in centimeters of water
- Driving Pressure [Up to 10 days]
Monitored Driving Pressure in centimeters of water as the difference between Total PEEP and Plateau Pressure in centimeters of water
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Fiorito | Avellaneda | Argentina | ||
| 2 | Sanatorio Norte SRL | Avellaneda | Argentina | ||
| 3 | Hospital Italiano Regional del Sur | Bahía Blanca | Argentina | ||
| 4 | Hospital privado Dr Raul Matera | Bahía Blanca | Argentina | ||
| 5 | Hospital Area Programa Bariloche "Ramón Carrillo" | Bariloche | Argentina | ||
| 6 | Cemic H.U. Pombo | Buenos Aires | Argentina | ||
| 7 | CEMIC H.U. Saavedra | Buenos Aires | Argentina | ||
| 8 | Clinica La Sagrada Familia | Buenos Aires | Argentina | ||
| 9 | Clinica y Maternidad Suizo Argentina | Buenos Aires | Argentina | ||
| 10 | Clinica Zabala | Buenos Aires | Argentina | ||
| 11 | Clínica Adventista Belgrano | Buenos Aires | Argentina | ||
| 12 | Clínica Bazterrica | Buenos Aires | Argentina | ||
| 13 | Clínica Pasteleros | Buenos Aires | Argentina | ||
| 14 | Complejo Medico de la Policia Federal Churruca Visca | Buenos Aires | Argentina | ||
| 15 | Cínica de los Virreyes | Buenos Aires | Argentina | ||
| 16 | Hospital Alemán | Buenos Aires | Argentina | ||
| 17 | Hospital Alvarez | Buenos Aires | Argentina | ||
| 18 | Hospital de Clínicas José de San Martín | Buenos Aires | Argentina | ||
| 19 | Hospital de Rehabilitación Respiratoria María Ferrer | Buenos Aires | Argentina | ||
| 20 | Hospital de Trauma y Emergencia Dr. Federico Abete | Buenos Aires | Argentina | ||
| 21 | Hospital Dr D. Velez Sarsfield | Buenos Aires | Argentina | ||
| 22 | Hospital Fernandez | Buenos Aires | Argentina | ||
| 23 | Hospital Francisco Javier Muñiz | Buenos Aires | Argentina | ||
| 24 | Hospital Generall de Agudos Dr Cosme Argerich | Buenos Aires | Argentina | ||
| 25 | Hospital Italiano de Buenos Aires | Buenos Aires | Argentina | ||
| 26 | Hospital Naval Pedro Mallo | Buenos Aires | Argentina | ||
| 27 | Hospital Piñero | Buenos Aires | Argentina | ||
| 28 | Hospital Ramos Mejía | Buenos Aires | Argentina | ||
| 29 | Hospital Santojanni SRS | Buenos Aires | Argentina | ||
| 30 | Hospital Santojanni | Buenos Aires | Argentina | ||
| 31 | Hospital Sirio Libanes | Buenos AIres | Argentina | ||
| 32 | Hospital Universitario Fundación Favaloro-UTI 1 | Buenos Aires | Argentina | ||
| 33 | Hospital Universitario Fundación Favaloro-UTI 2 | Buenos Aires | Argentina | ||
| 34 | Hospital Universitario UAI | Buenos AIres | Argentina | ||
| 35 | HZGA Dr alberto Balestrini | Buenos Aires | Argentina | ||
| 36 | Instituto Argentino de Diagnostico y Tratamiento | Buenos Aires | Argentina | ||
| 37 | Instituto de Trasplante y Alta Complejidad | Buenos Aires | Argentina | ||
| 38 | Instituto Lanari | Buenos Aires | Argentina | ||
| 39 | Instituto Médico de Alta Complejidad | Buenos Aires | Argentina | ||
| 40 | Sanatorio Anchorena | Buenos Aires | Argentina | ||
| 41 | Sanatorio Colegiales | Buenos Aires | Argentina | ||
| 42 | Sanatorio de la Trinidad Mitre | Buenos Aires | Argentina | ||
| 43 | Sanatorio de la Trinidad Palermo | Buenos Aires | Argentina | ||
| 44 | Sanatorio de los Arcos | Buenos Aires | Argentina | ||
| 45 | Sanatorio Finochietto | Buenos Aires | Argentina | ||
| 46 | Sanatorio Mater Dei | Buenos Aires | Argentina | ||
| 47 | Sanatorio Otamendi | Buenos Aires | Argentina | ||
| 48 | Hospital Municipal de Agudos Dr. Pedro Ecay | Carmen de Patagones | Argentina | ||
| 49 | Htal de alta complejidad cuenca alta SAMIC | Cañuelas | Argentina | ||
| 50 | Hospital Municipal del Carmen de Chacabuco | Chacabuco | Argentina | ||
| 51 | Hospital de Chivilcoy | Chivilcoy | Argentina | ||
| 52 | Policlinico Modelo Cipolletti | Cipolletti | Argentina | ||
| 53 | Hospital Carrillo de Ciudadela | Ciudadela | Argentina | ||
| 54 | Clinica del Valle | Comodoro Rivadavia | Argentina | ||
| 55 | Hospital Regional V Sanguinetti | Comodoro Rivadavia | Argentina | ||
| 56 | Hospital Zonal Alvear | Comodoro Rivadavia | Argentina | ||
| 57 | Hospital Justo José de Urquiza | Concepción Del Uruguay | Argentina | ||
| 58 | Clinica Chutro | Cordoba | Argentina | ||
| 59 | Clínica Santa Maria | Cordoba | Argentina | ||
| 60 | Clínica Universitaria Reina Fabiola | Cordoba | Argentina | ||
| 61 | Hospital Italiano | Cordoba | Argentina | ||
| 62 | Hospital Misericordia Nuevo Siglo | Cordoba | Argentina | ||
| 63 | Hospital Privado de Cordoba | Cordoba | Argentina | ||
| 64 | Hospital San Roque | Cordoba | Argentina | ||
| 65 | Sanatorio Allende Cerro | Cordoba | Argentina | ||
| 66 | Sanatorio Allende Nueva Córdoba | Cordoba | Argentina | ||
| 67 | Sanatorio Privado del Intenterio SRL | Cordoba | Argentina | ||
| 68 | Hospital Escuela Gral José de San Martín | Corrientes | Argentina | ||
| 69 | Instituto de Cardiologia Juana Francisca Cabral | Corrientes | Argentina | ||
| 70 | Hospital Córdoba | Córdoba | Argentina | ||
| 71 | Hospital Municipal Principe de Asturias | Córdoba | Argentina | ||
| 72 | Hospital Publico Provincial de la Ciudad de Córdoba | Córdoba | Argentina | ||
| 73 | Hospital Central de Formosa | Formosa | Argentina | ||
| 74 | Sanatorio Juan XXIII | General Roca | Argentina | ||
| 75 | Hospital Simplemente Evita | González Catán | Argentina | ||
| 76 | Hospital Eva Peron | Granadero Baigorria | Argentina | ||
| 77 | Hospital Profesor Dr Luis Guemes | Haedo | Argentina | ||
| 78 | Clínica la pequeña Familia | Junín | Argentina | ||
| 79 | Clínica Argentina | La Pampa | Argentina | ||
| 80 | HIEA y C "San Juan de Dios" | La Plata | Argentina | ||
| 81 | HIGA San Martín de La Plata | La Plata | Argentina | ||
| 82 | HIGA San Roque | La Plata | Argentina | ||
| 83 | Hospital español | La Plata | Argentina | ||
| 84 | Hospital Italiano de La Plata | La Plata | Argentina | ||
| 85 | Instituto Médico Platense | La Plata | Argentina | ||
| 86 | Ipensa | La Plata | Argentina | ||
| 87 | Sanatorio Adventista del Plata | La Plata | Argentina | ||
| 88 | HIGA Luisa Cravenna de Gandulfo | Lomas De Zamora | Argentina | ||
| 89 | Clinica 25 de Mayo | Mar Del Plata | Argentina | ||
| 90 | HIGA Dr Oscar Alende | Mar Del Plata | Argentina | ||
| 91 | Clinica Santa Maria | Mendoza | Argentina | ||
| 92 | Clinica Sociedad Española de Socorros Mutuos de Mendoza | Mendoza | Argentina | ||
| 93 | Hospital Central | Mendoza | Argentina | ||
| 94 | Hospital del Carmen | Mendoza | Argentina | ||
| 95 | Hospital Luis C Lagomaggiore | Mendoza | Argentina | ||
| 96 | Hospital Santa Isabel de Hungría | Mendoza | Argentina | ||
| 97 | Hospital Eva Perón | Merlo | Argentina | ||
| 98 | Clínica Monte Grande | Monte Grande | Argentina | ||
| 99 | HZGA Mariano y Luciano de la Vega | Moreno | Argentina | ||
| 100 | Hospital de Morón | Morón | Argentina | ||
| 101 | Hospital Nacional A. Posadas | Morón | Argentina | ||
| 102 | Sanatorio Clínica Modelo de Moron | Morón | Argentina | ||
| 103 | Hospital Municipal Emilio Ferreyra | Necochea | Argentina | ||
| 104 | Clinica CMIC | Neuquén | Argentina | ||
| 105 | Clínica Pasteur | Neuquén | Argentina | ||
| 106 | Clínica San Agustín | Neuquén | Argentina | ||
| 107 | Clinica Olivos | Olivos | Argentina | ||
| 108 | Hospital Militar Regional de Parana | Paraná | Argentina | ||
| 109 | HIGA San Jose de Pergamino | Pergamino | Argentina | ||
| 110 | Hospital Universitario Austral | Pilar | Argentina | ||
| 111 | Hospital Municipal de Pinamar | Pinamar | Argentina | ||
| 112 | Hospital Escuela de Agudos Dr. Ramon Madariaga | Posadas | Argentina | ||
| 113 | Hospital Público Autogestión SAMIC el Dorado | Posadas | Argentina | ||
| 114 | Hospital de Autogestión Samic Iguazú | Puerto Iguazu | Argentina | ||
| 115 | Sanatorio de la Ciudad S.R.L | Puerto Madryn | Argentina | ||
| 116 | Sanatorio de la Trinidad Quilmes | Quilmes | Argentina | ||
| 117 | Sanatorio de la Trinidad Ramos Mejía | Ramos Mejía | Argentina | ||
| 118 | Hospital central Reconquista | Reconquista | Argentina | ||
| 119 | Hospital Dr. Julio Perrando | Resistencia | Argentina | ||
| 120 | Hospital Español de Rosario | Rosario | Argentina | ||
| 121 | Policlinico PAMI 1 | Rosario | Argentina | ||
| 122 | Sanatorio Mapaci | Rosario | Argentina | ||
| 123 | Sanatorio Parque | Rosario | Argentina | ||
| 124 | Hospital del Sr. del Milagro | Salta | Argentina | ||
| 125 | Hospital Papa Francisco | Salta | Argentina | ||
| 126 | Hospital Publico de Auogestión Dr Arturo Oñativia | Salta | Argentina | ||
| 127 | HPGD San Bernardo | Salta | Argentina | ||
| 128 | Instituto Medico de la Comunidad | San Fernando Del Valle De Catamarca | Argentina | ||
| 129 | HIGA Petrona V. de Cordero de San Fernando | San Fernando | Argentina | ||
| 130 | Sanatorio de la Trinidad San Isidro | San Isidro | Argentina | ||
| 131 | Sanatorio Las Lomas | San Isidro | Argentina | ||
| 132 | Centro de Cuidados Intensivos | San Juan | Argentina | ||
| 133 | Clinica Santa Clara de la Porvincia de San Juan | San Juan | Argentina | ||
| 134 | Hospital Dr Guillermo Rawson | San Juan | Argentina | ||
| 135 | Hospital Público descentralizado Dr. Marcial Vicente Quiroga. | San Juan | Argentina | ||
| 136 | Hospital Italiano de San Justo | San Justo | Argentina | ||
| 137 | Hospital Madre Catalina | San Luis | Argentina | ||
| 138 | Hospital San Luis | San Luis | Argentina | ||
| 139 | Hospital Centro de Salud Zenón Santillán | San Miguel De Tucumán | Argentina | ||
| 140 | Hospital de clínica Presidente Doctor Nicolas Avellaneda | San Miguel De Tucumán | Argentina | ||
| 141 | Sanatorio Lavalle | San Salvador De Jujuy | Argentina | ||
| 142 | Sanatorio Nuestra Sra del Rosario | San Salvador De Jujuy | Argentina | ||
| 143 | Htal Cullen de Santa Fe | Santa Fe | Argentina | ||
| 144 | Sanatorio Español | Santa Fe | Argentina | ||
| 145 | Sanatorio Santa Fe | Santa Fe | Argentina | ||
| 146 | Sanatorio Santa Fé | Santa Fe | Argentina | ||
| 147 | Centro Integral de Salud Banda | Santiago Del Estero | Argentina | ||
| 148 | Hospital regional Dr. Ramon Carrillo | Santiago Del Estero | Argentina | ||
| 149 | Hospital Ramón Santamarina | Tandil | Argentina | ||
| 150 | Sanatorio Juncal | Temperley | Argentina | ||
| 151 | Hospital Regional de Ushuaia | Ushuaia | Argentina | ||
| 152 | Hospital Nodal Dr. Alejandro Gutierrez | Venado Tuerto | Argentina | ||
| 153 | Hospital Houssay | Vicente López | Argentina | ||
| 154 | Hospital Artemides Zatti | Viedma | Argentina |
Sponsors and Collaborators
- Argentinian Intensive Care Society
Investigators
- Principal Investigator: Gustavo Plotnikow, RT, Sanatorio Anchorena
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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.
- 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.
Responsible Party:
Gustavo Plotnikow,
Physical and Respiratory Therapist, Head of Physical and Respiratory Therapist Department, Sanatorio Anchorena, Buenos Aires, Argentina,
Argentinian Intensive Care Society
ClinicalTrials.gov Identifier:
NCT04107467
Other Study ID Numbers:
- EpVAr
First Posted:
Sep 27, 2019
Last Update Posted:
Oct 22, 2020
Last Verified:
Oct 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No