NCT04107467

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
950

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Shorter than P25 for all trials

Geographic Reach
1 country

154 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 9, 2019

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

October 22, 2020

Status Verified

October 1, 2020

Enrollment Period

3 months

First QC Date

September 25, 2019

Last Update Submit

October 21, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (14)

  • Main reason of Invasive Mechanical Ventilation

    1 day

  • Ventilatory Modes and setting

    Up to 10 days

  • Tidal Volume

    Up to 10 days

  • Weaning and mortality

    Up to 28 days

  • Noninvasive ventilation during weaning and mortality

    Up to 28 days

  • +9 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adult patients who require mechanical ventilation for at least 12 hours in the argentinians ICU will be enrolled.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (154)

Hospital Fiorito

Avellaneda, Argentina

Location

Sanatorio Norte SRL

Avellaneda, Argentina

Location

Hospital Italiano Regional del Sur

Bahía Blanca, Argentina

Location

Hospital privado Dr Raul Matera

Bahía Blanca, Argentina

Location

Hospital Area Programa Bariloche "Ramón Carrillo"

Bariloche, Argentina

Location

Cemic H.U. Pombo

Buenos Aires, Argentina

Location

CEMIC H.U. Saavedra

Buenos Aires, Argentina

Location

Clinica La Sagrada Familia

Buenos Aires, Argentina

Location

Clinica y Maternidad Suizo Argentina

Buenos Aires, Argentina

Location

Clinica Zabala

Buenos Aires, Argentina

Location

Clínica Adventista Belgrano

Buenos Aires, Argentina

Location

Clínica Bazterrica

Buenos Aires, Argentina

Location

Clínica Pasteleros

Buenos Aires, Argentina

Location

Complejo Medico de la Policia Federal Churruca Visca

Buenos Aires, Argentina

Location

Cínica de los Virreyes

Buenos Aires, Argentina

Location

Hospital Alemán

Buenos Aires, Argentina

Location

Hospital Alvarez

Buenos Aires, Argentina

Location

Hospital de Clínicas José de San Martín

Buenos Aires, Argentina

Location

Hospital de Rehabilitación Respiratoria María Ferrer

Buenos Aires, Argentina

Location

Hospital de Trauma y Emergencia Dr. Federico Abete

Buenos Aires, Argentina

Location

Hospital Dr D. Velez Sarsfield

Buenos Aires, Argentina

Location

Hospital Fernandez

Buenos Aires, Argentina

Location

Hospital Francisco Javier Muñiz

Buenos Aires, Argentina

Location

Hospital Generall de Agudos Dr Cosme Argerich

Buenos Aires, Argentina

Location

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Location

Hospital Naval Pedro Mallo

Buenos Aires, Argentina

Location

Hospital Piñero

Buenos Aires, Argentina

Location

Hospital Ramos Mejía

Buenos Aires, Argentina

Location

Hospital Santojanni SRS

Buenos Aires, Argentina

Location

Hospital Santojanni

Buenos Aires, Argentina

Location

Hospital Sirio Libanes

Buenos Aires, Argentina

Location

Hospital Universitario Fundación Favaloro-UTI 1

Buenos Aires, Argentina

Location

Hospital Universitario Fundación Favaloro-UTI 2

Buenos Aires, Argentina

Location

Hospital Universitario UAI

Buenos Aires, Argentina

Location

HZGA Dr alberto Balestrini

Buenos Aires, Argentina

Location

Instituto Argentino de Diagnostico y Tratamiento

Buenos Aires, Argentina

Location

Instituto de Trasplante y Alta Complejidad

Buenos Aires, Argentina

Location

Instituto Lanari

Buenos Aires, Argentina

Location

Instituto Médico de Alta Complejidad

Buenos Aires, Argentina

Location

Sanatorio Anchorena

Buenos Aires, Argentina

Location

Sanatorio Colegiales

Buenos Aires, Argentina

Location

Sanatorio de la Trinidad Mitre

Buenos Aires, Argentina

Location

Sanatorio de la Trinidad Palermo

Buenos Aires, Argentina

Location

Sanatorio de los Arcos

Buenos Aires, Argentina

Location

Sanatorio Finochietto

Buenos Aires, Argentina

Location

Sanatorio Mater Dei

Buenos Aires, Argentina

Location

Sanatorio Otamendi

Buenos Aires, Argentina

Location

Htal de alta complejidad cuenca alta SAMIC

Cañuelas, Argentina

Location

Hospital Municipal de Agudos Dr. Pedro Ecay

Carmen de Patagones, Argentina

Location

Instituto Medico de la Comunidad

Catamarca, Argentina

Location

Hospital Municipal del Carmen de Chacabuco

Chacabuco, Argentina

Location

Hospital de Chivilcoy

Chivilcoy, Argentina

Location

Policlinico Modelo Cipolletti

Cipolletti, Argentina

Location

Hospital Carrillo de Ciudadela

Ciudadela, Argentina

Location

Clinica del Valle

Comodoro Rivadavia, Argentina

Location

Hospital Regional V Sanguinetti

Comodoro Rivadavia, Argentina

Location

Hospital Zonal Alvear

Comodoro Rivadavia, Argentina

Location

Hospital Justo José de Urquiza

Concepción del Uruguay, Argentina

Location

Hospital Escuela Gral José de San Martín

Corrientes, Argentina

Location

Instituto de Cardiologia Juana Francisca Cabral

Corrientes, Argentina

Location

Clinica Chutro

Córdoba, Argentina

Location

Clínica Santa Maria

Córdoba, Argentina

Location

Clínica Universitaria Reina Fabiola

Córdoba, Argentina

Location

Hospital Córdoba

Córdoba, Argentina

Location

Hospital Italiano

Córdoba, Argentina

Location

Hospital Misericordia Nuevo Siglo

Córdoba, Argentina

Location

Hospital Municipal Principe de Asturias

Córdoba, Argentina

Location

Hospital Privado de Cordoba

Córdoba, Argentina

Location

Hospital Publico Provincial de la Ciudad de Córdoba

Córdoba, Argentina

Location

Hospital San Roque

Córdoba, Argentina

Location

Sanatorio Allende Cerro

Córdoba, Argentina

Location

Sanatorio Allende Nueva Córdoba

Córdoba, Argentina

Location

Sanatorio Privado del Intenterio SRL

Córdoba, Argentina

Location

Hospital Central de Formosa

Formosa, Argentina

Location

Sanatorio Juan XXIII

General Roca, Argentina

Location

Hospital Simplemente Evita

González Catán, Argentina

Location

Hospital Eva Peron

Granadero Baigorria, Argentina

Location

Hospital Profesor Dr Luis Guemes

Haedo, Argentina

Location

Clínica la pequeña Familia

Junín, Argentina

Location

Clínica Argentina

La Pampa, Argentina

Location

HIEA y C "San Juan de Dios"

La Plata, Argentina

Location

HIGA San Martín de La Plata

La Plata, Argentina

Location

HIGA San Roque

La Plata, Argentina

Location

Hospital español

La Plata, Argentina

Location

Hospital Italiano de La Plata

La Plata, Argentina

Location

Instituto Médico Platense

La Plata, Argentina

Location

Ipensa

La Plata, Argentina

Location

Sanatorio Adventista del Plata

La Plata, Argentina

Location

HIGA Luisa Cravenna de Gandulfo

Lomas de Zamora, Argentina

Location

Clinica 25 de Mayo

Mar del Plata, Argentina

Location

HIGA Dr Oscar Alende

Mar del Plata, Argentina

Location

Clinica Santa Maria

Mendoza, Argentina

Location

Clinica Sociedad Española de Socorros Mutuos de Mendoza

Mendoza, Argentina

Location

Hospital Central

Mendoza, Argentina

Location

Hospital del Carmen

Mendoza, Argentina

Location

Hospital Luis C Lagomaggiore

Mendoza, Argentina

Location

Hospital Santa Isabel de Hungría

Mendoza, Argentina

Location

Hospital Eva Perón

Merlo, Argentina

Location

Clínica Monte Grande

Monte Grande, Argentina

Location

HZGA Mariano y Luciano de la Vega

Moreno, Argentina

Location

Hospital de Morón

Morón, Argentina

Location

Hospital Nacional A. Posadas

Morón, Argentina

Location

Sanatorio Clínica Modelo de Moron

Morón, Argentina

Location

Hospital Municipal Emilio Ferreyra

Necochea, Argentina

Location

Clinica CMIC

Neuquén, Argentina

Location

Clínica Pasteur

Neuquén, Argentina

Location

Clínica San Agustín

Neuquén, Argentina

Location

Clinica Olivos

Olivos, Argentina

Location

Hospital Militar Regional de Parana

Paraná, Argentina

Location

HIGA San Jose de Pergamino

Pergamino, Argentina

Location

Hospital Universitario Austral

Pilar, Argentina

Location

Hospital Municipal de Pinamar

Pinamar, Argentina

Location

Hospital Escuela de Agudos Dr. Ramon Madariaga

Posadas, Argentina

Location

Hospital Público Autogestión SAMIC el Dorado

Posadas, Argentina

Location

Hospital de Autogestión Samic Iguazú

Puerto Iguazú, Argentina

Location

Sanatorio de la Ciudad S.R.L

Puerto Madryn, Argentina

Location

Sanatorio de la Trinidad Quilmes

Quilmes, Argentina

Location

Sanatorio de la Trinidad Ramos Mejía

Ramos Mejía, Argentina

Location

Hospital central Reconquista

Reconquista, Argentina

Location

Hospital Dr. Julio Perrando

Resistencia, Argentina

Location

Hospital Español de Rosario

Rosario, Argentina

Location

Policlinico PAMI 1

Rosario, Argentina

Location

Sanatorio Mapaci

Rosario, Argentina

Location

Sanatorio Parque

Rosario, Argentina

Location

Hospital del Sr. del Milagro

Salta, Argentina

Location

Hospital Papa Francisco

Salta, Argentina

Location

Hospital Publico de Auogestión Dr Arturo Oñativia

Salta, Argentina

Location

HPGD San Bernardo

Salta, Argentina

Location

HIGA Petrona V. de Cordero de San Fernando

San Fernando, Argentina

Location

Sanatorio de la Trinidad San Isidro

San Isidro, Argentina

Location

Sanatorio Las Lomas

San Isidro, Argentina

Location

Centro de Cuidados Intensivos

San Juan, Argentina

Location

Clinica Santa Clara de la Porvincia de San Juan

San Juan, Argentina

Location

Hospital Dr Guillermo Rawson

San Juan, Argentina

Location

Hospital Público descentralizado Dr. Marcial Vicente Quiroga.

San Juan, Argentina

Location

Hospital Italiano de San Justo

San Justo, Argentina

Location

Hospital Madre Catalina

San Luis, Argentina

Location

Hospital San Luis

San Luis, Argentina

Location

Hospital Centro de Salud Zenón Santillán

San Miguel de Tucumán, Argentina

Location

Hospital de clínica Presidente Doctor Nicolas Avellaneda

San Miguel de Tucumán, Argentina

Location

Sanatorio Lavalle

San Salvador de Jujuy, Argentina

Location

Sanatorio Nuestra Sra del Rosario

San Salvador de Jujuy, Argentina

Location

Htal Cullen de Santa Fe

Santa Fe, Argentina

Location

Sanatorio Español

Santa Fe, Argentina

Location

Sanatorio Santa Fe

Santa Fe, Argentina

Location

Sanatorio Santa Fé

Santa Fe, Argentina

Location

Centro Integral de Salud Banda

Santiago del Estero, Argentina

Location

Hospital regional Dr. Ramon Carrillo

Santiago del Estero, Argentina

Location

Hospital Ramón Santamarina

Tandil, Argentina

Location

Sanatorio Juncal

Temperley, Argentina

Location

Hospital Regional de Ushuaia

Ushuaia, Argentina

Location

Hospital Nodal Dr. Alejandro Gutierrez

Venado Tuerto, Argentina

Location

Hospital Houssay

Vicente López, Argentina

Location

Hospital Artemides Zatti

Viedma, Argentina

Location

Related Publications (17)

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    PMID: 21297069BACKGROUND
  • 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. doi: 10.1164/ajrccm.150.4.7921460.

    PMID: 7921460BACKGROUND
  • 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 syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.

  • Esteban A, Frutos F, Tobin MJ, Alia I, Solsona JF, Valverdu I, Fernandez R, de la Cal MA, Benito S, Tomas R, et al. A comparison of four methods of weaning patients from mechanical ventilation. Spanish Lung Failure Collaborative Group. N Engl J Med. 1995 Feb 9;332(6):345-50. doi: 10.1056/NEJM199502093320601.

  • Esteban A, Alia I, Gordo F, Fernandez R, Solsona JF, Vallverdu I, Macias S, Allegue JM, Blanco J, Carriedo D, Leon M, de la Cal MA, Taboada F, Gonzalez de Velasco J, Palazon E, Carrizosa F, Tomas R, Suarez J, Goldwasser RS. Extubation outcome after spontaneous breathing trials with T-tube or pressure support ventilation. The Spanish Lung Failure Collaborative Group. Am J Respir Crit Care Med. 1997 Aug;156(2 Pt 1):459-65. doi: 10.1164/ajrccm.156.2.9610109.

  • Esteban A, Anzueto A, Frutos F, Alia I, Brochard L, Stewart TE, Benito S, Epstein SK, Apezteguia C, Nightingale P, Arroliga AC, Tobin MJ; Mechanical Ventilation International Study Group. Characteristics and outcomes in adult patients receiving mechanical ventilation: a 28-day international study. JAMA. 2002 Jan 16;287(3):345-55. doi: 10.1001/jama.287.3.345.

  • Esteban A, Frutos-Vivar F, Muriel A, Ferguson ND, Penuelas O, Abraira V, Raymondos K, Rios F, Nin N, Apezteguia C, Violi DA, Thille AW, Brochard L, Gonzalez M, Villagomez AJ, Hurtado J, Davies AR, Du B, Maggiore SM, Pelosi P, Soto L, Tomicic V, D'Empaire G, Matamis D, Abroug F, Moreno RP, Soares MA, Arabi Y, Sandi F, Jibaja M, Amin P, Koh Y, Kuiper MA, Bulow HH, Zeggwagh AA, Anzueto A. Evolution of mortality over time in patients receiving mechanical ventilation. Am J Respir Crit Care Med. 2013 Jul 15;188(2):220-30. doi: 10.1164/rccm.201212-2169OC.

  • 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 (Epidemiology of Respiratory Insufficiency in Critical Care) investigators. Clinical outcomes of patients requiring ventilatory support in Brazilian intensive care units: a multicenter, prospective, cohort study. Crit Care. 2013 Apr 4;17(2):R63. doi: 10.1186/cc12594.

  • Tomicic V, Espinoza M, Andresen M, Molina J, Calvo M, Ugarte H, Godoy J, Galvez S, Maurelia JC, Delgado I, Esteban A; Grupo Chileno para el Estudio de la Ventilacion Mecanica. [Characteristics and factors associated with mortality in patients receiving mechanical ventilation: first Chilean multicenter study]. Rev Med Chil. 2008 Aug;136(8):959-67. Epub 2008 Oct 7. Spanish.

  • 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. doi: 10.1016/0021-9681(87)90171-8.

  • 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.2008.01.006. Epub 2008 Jul 10.

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  • Fabregas 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. doi: 10.1136/thx.54.10.867.

  • Devlin JW, Skrobik Y, Gelinas 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 JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.

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Related Links

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gustavo Plotnikow, RT

    Sanatorio Anchorena

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
28 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical and Respiratory Therapist, Head of Physical and Respiratory Therapist Department, Sanatorio Anchorena, Buenos Aires, Argentina

Study Record Dates

First Submitted

September 25, 2019

First Posted

September 27, 2019

Study Start

September 9, 2019

Primary Completion

November 30, 2019

Study Completion

December 31, 2019

Last Updated

October 22, 2020

Record last verified: 2020-10

Locations