Third International Study on Mechanical Ventilation (ISMV)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Andres Esteban, Hospital Universitario Getafe
ClinicalTrials.gov Identifier:
NCT01093482
First received: March 23, 2010
Last updated: June 15, 2013
Last verified: May 2012
  Purpose

The objective of this study is to obtain a better understanding of the spectrum of use of mechanical ventilation in intensive care units:

  1. Main analysis: To know the all-cause mortality rate in mechanically ventilated patients
  2. Secondary analyses:

    • To know the current status of mechanical ventilation in the intensive care unit and determine the number and percentage of patients who are admitted to an intensive care unit and require mechanical ventilation.
    • To compare the results with prior data collected in previous observational studies (1998 and 2004)
    • Non-invasive positive pressure ventilation
    • Weaning
    • Use of adjuvant therapies as steroids or selective digestive decontamination
    • Sedation including prevalence of delirium in mechanically ventilated patients
    • Prediction of the duration of mechanical ventilation
    • Other

Condition
Acute Respiratory Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Third Prospective, Observational, International, Multicenter Study on Mechanical Ventilation

Resource links provided by NLM:


Further study details as provided by Hospital Universitario Getafe:

Primary Outcome Measures:
  • All-cause mortality [ Time Frame: At day 28 after the beginning of mechanical ventilation ] [ Designated as safety issue: No ]

Enrollment: 8151
Study Start Date: April 2010
Study Completion Date: September 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
mechanically ventilated patients
  1. Patients who are admitted to the participating intensive care units and require invasive mechanical ventilation (endotracheal tube or tracheostomy) for more than 12 hours.
  2. Patients who are admitted to the participating intensive care units and require non-invasive mechanical ventilation (Bilevel positive airway pressure (BIPAP) or continuous positive airway pressure (CPAP) with nasal or facial mask) for more than 1 hour.

Detailed Description:

Mechanical ventilation is commonly used in patients admitted to intensive care units. Clinical studies have investigated some of the aspects associated with its utilization, and have contributed to improve the knowledge and management of patients with acute respiratory failure. In 1998 the invesgtigators conducted the first international study on mechanical ventilation, including 5183 patients who were mechanically ventilated longer than 12 hours (Esteban A. JAMA 2002). Six years later, the investigators carried out the second international study on mechanical ventilation including 4968 patients. These studies allowed us to analyze the evolution of mechanical ventilation and to judge the concordance of practice with results of randomized trials (Esteban A. Am J Respir Crit Care 2008). The main finding of this study was the high degree of concordance between observed changes in mechanical ventilation practice and changes predicted from reports of randomized controlled trials. However, despite apparently beneficial changes in ventilatory practice, the investigators were not able to detect significant differences in clinical outcomes over this time period. Our results serve as an updated benchmark on the usual care and outcomes of mechanically ventilated patients in a 'real-world' setting.

The investigators now propose to conduct a third international study of mechanical ventilation, 6 years after the 2nd study and 12 years after the original. This will again be a prospective, multicenter single-cohort study, which will enroll consecutive patients who have received mechanical ventilation for at least 12 hours during a 1-month period, and will follow each patient for the duration of mechanical ventilation, up to 28 days. With this 3rd study the investigators aim: 1) to determine if the observed changes that the investigators reported previously are maintained over time; 2) to evaluate if the changes implemented have impacted outcomes; 3) to analyze some aspects related to withdrawal of mechanical ventilation; and implementation non-invasive positive pressure ventilation; and 4) to evaluate what differences may occur between geographical areas.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Mechanically ventilated patients

Criteria

Inclusion Criteria:

  • Patients who are admitted to the intensive care unit and require invasive mechanical ventilation (endotracheal tube or tracheostomy) for more than 12 hours.
  • Patients who are admitted to the intensive care unit and require non-invasive mechanical ventilation (BIPAP or CPAP with nasal or facial mask) for more than 1 hour.

Exclusion Criteria:

  • Patients less than 18 years old
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01093482

  Show 477 Study Locations
Sponsors and Collaborators
Hospital Universitario Getafe
Investigators
Study Director: Andres Esteban, MD, PhD Hospital Universitario de Getafe, Spain
Principal Investigator: Fernando Frutos-Vivar, MD Hospital Universitario de Getafe, Spain
Principal Investigator: Niall D Ferguson, MD, MsC University of Toronto, Ontario, Canada
Principal Investigator: Antonio Anzueto, MD University of Texas Health Science Center, San Antonio, Texas, USA
Principal Investigator: Marco González, MD Clinica Medellin & Universidad Pontificia Bolivariana, Colombia
Principal Investigator: Arnaud W Thille, MD AP-HP, Centre Hospitalier Albert Chenevier, Henri Mondor, Créteil, France
Principal Investigator: Konstantinos Raymondos, MD Hannover Medical School
Principal Investigator: Salvatore Maggiore, MD Agostino Gemelli University Hospital, Università Cattolica del Sacro Cuore, Rome, Italy
Principal Investigator: Yaseen Arabi, MD King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia
Principal Investigator: Rui Moreno, MD Hospital de Santo António dos Capuchos, Lisboa, Portugal
Principal Investigator: Fekri Abroug, MD Fattouma Bourguiba, Monastir, Tunisia
Principal Investigator: Javier Hurtado, MD Hospital de Clínicas, Montevideo, Uruguay
Principal Investigator: Fernando Rios, MD Hospital A.Posadas, Buenos Aires, Argentina
Principal Investigator: Luis Soto, MD Hospital Nacional del Tórax, Santiago, Chile
Principal Investigator: Damian Violi, MD Hospital HIGA, Güemes, Argentina
Principal Investigator: Jasmine Board, MD Alfred Hospital, Melbourne, Australia
Principal Investigator: Andrew Davies, MD Alfred Hospital, Melbourne, Australia
Principal Investigator: Fredi Sandi Lora, MD Hospital Obrero Número 1, La Paz, Bolivia
Principal Investigator: Marco Antonio Soares Reis, MD Hospital Universitário São José, Belo Horizonte, Brazil
Principal Investigator: Bin Du, MD Peking Union Medical College Hospital, Beijing, Popular Republic of China
Principal Investigator: Hans-Henrik Bülow, MD Holbak, Denmark
Principal Investigator: Manuel Jibaja, MD Hospital Militar de Quito, Ecuador
Principal Investigator: Dimitros Matamis, MD Papageorgiou Hospital, Thessaloniki, Greece
Principal Investigator: Younsuck Koh, MD Asan Medical Center, University of Ulsan, Seoul, Korea
Principal Investigator: Asisclo Villagómez, MD Hospital Regional 1° de Octubre, ISSSTE, México DF, Mexico
Principal Investigator: Amine Ali Zeggwagh, MD Hôpital Ibn Sina, Rabat, Morocco
Principal Investigator: Michael Kuiper, MD Medical Center Leeuwarden (MCL), Leeuwarden, The Netherlands
Principal Investigator: Edward Nicolayenko, MD Hospital No.1, Moscow, Russian Federation
Principal Investigator: Nicolas Nin, MD Hospital Universitario de Getafe, Spain
Principal Investigator: Nahit Cakar, MD Istanbul Medical Faculty, Istanbul, Turkey
Principal Investigator: Gabriel D'Empaire, MD Hospital de Clinicas de Caracas, Venezuela
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Andres Esteban, MD, Hospital Universitario Getafe
ClinicalTrials.gov Identifier: NCT01093482     History of Changes
Other Study ID Numbers: ISMV-2010
Study First Received: March 23, 2010
Last Updated: June 15, 2013
Health Authority: Spain: Ethics Committee

Keywords provided by Hospital Universitario Getafe:
mechanical ventilation
epidemiology
outcomes
mortality
weaning
sedation
non-invasive positive pressure ventilation

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders

ClinicalTrials.gov processed this record on July 28, 2014