Fourth International Study of Mechanical Ventilation From VENTILA GROUP

NCT02731898 | Unknown DMC

• 1 other identifier: ISMV2016
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 3

Brief Summary

A prospective, international and multicenter, non interventional single-cohort study, which will enroll consecutive adult patients who have received mechanical ventilation (invasive and noninvasive 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. The main objectives will be to analyze the mortality and clinical outcomes in ventilated patients and secondly, to evaluate the practices of liberation from mechanical ventilation, the failure of non invasive ventilation in the ICU, and to analyze the clinical outcomes in specific populations of critically ill patients with the need of mechanical ventilation.

Conditions

Acute Respiratory Failure, Mechanical Ventilation, Critically Ill Patients, Mortality

Outcome Measures

Primary Outcomes (1)

• ICU Mortality,

  number of patients admited in the ICU that died during their ICU stay for any cause

  one month

Secondary Outcomes (10)

• duration of mechanical ventilation

  one month

• duration of period of liberation from mechanical ventilation

  one month

• extubation failure

  one month

• reintubation rate

  one month

• tracheostomy rate

  one month

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In order to include patients from different countries and being comparable between them, the coordinator team will create some definitions for the selection of the participating ICUs from each country and inclusion criteria for the patients, as following. This study will be conducted in Intensive Care Units (\[Medical ICU, MICU\], Coronary ICU \[CCU\], Surgical ICU \[SICU\], neurocritical ICU) that meet the following criteria: 1. ICUs that have six or more beds and/or average (during prior 12 months) of more than 30% of the patients admitted requiring mechanical ventilation. 2. ICUs that have staff specialists in Intensive Care Medicine, or visiting physicians with intensive care training and/or physicians who have more than five years of intensive care experience.

You may qualify if:

• Patients who are admitted to the ICU and will require invasive mechanical ventilation (endotracheal tube or tracheostomy) longer than 12 hours.
• Patients who are admitted to the ICU and will require NIV (Continuos Positive Airway Pressure \[CPAP\], or refers to Bilevel Positive Airway Pressure \[BIPAP\] with oronasal, nasal, helmet or facial mask) for more than 1 hour.
• Patients in whom mechanical ventilation was started outside the study ICU at the same Institution and/or a different Institution, including Emergency Room, Operating Room (OR), and were then transferred to the ICU at the participating center.

You may not qualify if:

• Pediatric ICU.
• Post-Operators Anesthesia Recovery Room.
• Patients less than 18 years old will be also excluded.
• Patients admitted after elective surgery and who require mechanical ventilation for less than 12 hours (excepting patients who receive NIV).

Sponsors & Collaborators

• Hospital Universitario Getafe: lead

Study Sites (3)

Intensive Care Unit, Hospital Universitario de Getafe

Getafe, Madrid, 28905, Spain

RECRUITING

Hospital de Cruces

Barakaldo, Vizcaya, Spain

RECRUITING

Complejo Hospitalario Universitario de A Coruna

A Coruña, Spain

RECRUITING

Related Publications (14)

• 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.

  PMID: 23631814 RESULT

• Esteban A, Ferguson ND, Meade MO, Frutos-Vivar F, Apezteguia C, Brochard L, Raymondos K, Nin N, Hurtado J, Tomicic V, Gonzalez M, Elizalde J, Nightingale P, Abroug F, Pelosi P, Arabi Y, Moreno R, Jibaja M, D'Empaire G, Sandi F, Matamis D, Montanez AM, Anzueto A; VENTILA Group. Evolution of mechanical ventilation in response to clinical research. Am J Respir Crit Care Med. 2008 Jan 15;177(2):170-7. doi: 10.1164/rccm.200706-893OC. Epub 2007 Oct 25.

  PMID: 17962636 RESULT

• Girard TD, Kress JP, Fuchs BD, Thomason JW, Schweickert WD, Pun BT, Taichman DB, Dunn JG, Pohlman AS, Kinniry PA, Jackson JC, Canonico AE, Light RW, Shintani AK, Thompson JL, Gordon SM, Hall JB, Dittus RS, Bernard GR, Ely EW. Efficacy and safety of a paired sedation and ventilator weaning protocol for mechanically ventilated patients in intensive care (Awakening and Breathing Controlled trial): a randomised controlled trial. Lancet. 2008 Jan 12;371(9607):126-34. doi: 10.1016/S0140-6736(08)60105-1.

  PMID: 18191684 RESULT

• Needham DM, Bronskill SE, Sibbald WJ, Pronovost PJ, Laupacis A. Mechanical ventilation in Ontario, 1992-2000: incidence, survival, and hospital bed utilization of noncardiac surgery adult patients. Crit Care Med. 2004 Jul;32(7):1504-9. doi: 10.1097/01.ccm.0000129972.31533.37.

  PMID: 15241095 RESULT

• 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.

  PMID: 11790214 RESULT

• Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62. doi: 10.1001/jama.291.14.1753.

  PMID: 15082703 RESULT

• Carlucci A, Richard JC, Wysocki M, Lepage E, Brochard L; SRLF Collaborative Group on Mechanical Ventilation. Noninvasive versus conventional mechanical ventilation. An epidemiologic survey. Am J Respir Crit Care Med. 2001 Mar;163(4):874-80. doi: 10.1164/ajrccm.163.4.2006027.

  PMID: 11282759 RESULT

• Schnell D, Timsit JF, Darmon M, Vesin A, Goldgran-Toledano D, Dumenil AS, Garrouste-Orgeas M, Adrie C, Bouadma L, Planquette B, Cohen Y, Schwebel C, Soufir L, Jamali S, Souweine B, Azoulay E. Noninvasive mechanical ventilation in acute respiratory failure: trends in use and outcomes. Intensive Care Med. 2014 Apr;40(4):582-91. doi: 10.1007/s00134-014-3222-y. Epub 2014 Feb 7.

  PMID: 24504643 RESULT

• Amato MB, Meade MO, Slutsky AS, Brochard L, Costa EL, Schoenfeld DA, Stewart TE, Briel M, Talmor D, Mercat A, Richard JC, Carvalho CR, Brower RG. Driving pressure and survival in the acute respiratory distress syndrome. N Engl J Med. 2015 Feb 19;372(8):747-55. doi: 10.1056/NEJMsa1410639.

  PMID: 25693014 RESULT

• Roca O, Penuelas O, Muriel A, Garcia-de-Acilu M, Laborda C, Sacanell J, Riera J, Raymondos K, Du B, Thille AW, Rios F, Gonzalez M, Del-Sorbo L, Del Carmen Marin M, Soares MA, Pinheiro BV, Nin N, Maggiore SM, Bersten A, Amin P, Cakar N, Suh GY, Abroug F, Jibaja M, Matamis D, Zeggwagh AA, Sutherasan Y, Anzueto A, Esteban A, Frutos-Vivar F. Driving Pressure Is a Risk Factor for ARDS in Mechanically Ventilated Subjects Without ARDS. Respir Care. 2021 Oct;66(10):1505-1513. doi: 10.4187/respcare.08587. Epub 2021 Aug 3.

  PMID: 34344717 DERIVED

• Mamandipoor B, Frutos-Vivar F, Penuelas O, Rezar R, Raymondos K, Muriel A, Du B, Thille AW, Rios F, Gonzalez M, Del-Sorbo L, Del Carmen Marin M, Pinheiro BV, Soares MA, Nin N, Maggiore SM, Bersten A, Kelm M, Bruno RR, Amin P, Cakar N, Suh GY, Abroug F, Jibaja M, Matamis D, Zeggwagh AA, Sutherasan Y, Anzueto A, Wernly B, Esteban A, Jung C, Osmani V. Machine learning predicts mortality based on analysis of ventilation parameters of critically ill patients: multi-centre validation. BMC Med Inform Decis Mak. 2021 May 7;21(1):152. doi: 10.1186/s12911-021-01506-w.

  PMID: 33962603 DERIVED

• Wernly B, Bruno RR, Frutos-Vivar F, Penuelas O, Rezar R, Raymondos K, Muriel A, Du B, Thille AW, Rios F, Gonzalez M, Del-Sorbo L, Marin MDC, Pinheiro BV, Soares MA, Nin N, Maggiore SM, Bersten A, Kelm M, Amin P, Cakar N, Young Suh G, Abroug F, Jibaja M, Matamis D, Zeggwagh AA, Sutherasan Y, Guidet B, De Lange DW, Beil M, Svri S, van Heerden V, Flaatten H, Anzueto A, Osmani V, Esteban A, Jung C. Propensity-Adjusted Comparison of Mortality of Elderly Versus Very Elderly Ventilated Patients. Respir Care. 2021 May;66(5):814-821. doi: 10.4187/respcare.08547. Epub 2021 Mar 2.

  PMID: 33653910 DERIVED

• Penuelas O, Muriel A, Abraira V, Frutos-Vivar F, Mancebo J, Raymondos K, Du B, Thille AW, Rios F, Gonzalez M, Del-Sorbo L, Ferguson ND, Del Carmen Marin M, Pinheiro BV, Soares MA, Nin N, Maggiore SM, Bersten A, Amin P, Cakar N, Suh GY, Abroug F, Jibaja M, Matamis D, Zeggwagh AA, Sutherasan Y, Anzueto A, Esteban A. Inter-country variability over time in the mortality of mechanically ventilated patients. Intensive Care Med. 2020 Mar;46(3):444-453. doi: 10.1007/s00134-019-05867-9. Epub 2020 Jan 7.

  PMID: 31912203 DERIVED

• Wernly B, Frutos-Vivar F, Penuelas O, Raymondos K, Muriel A, Du B, Thille AW, Rios F, Gonzalez M, Del-Sorbo L, Del Carmen Marin M, Pinheiro BV, Soares MA, Nin N, Maggiore SM, Bersten A, Kelm M, Amin P, Cakar N, Lichtenauer M, Suh GY, Abroug F, Jibaja M, Matamis D, Zeggwagh AA, Sutherasan Y, Anzueto A, Esteban A, Jung C. Easy prognostic assessment of concomitant organ failure in critically ill patients undergoing mechanical ventilation. Eur J Intern Med. 2019 Dec;70:18-23. doi: 10.1016/j.ejim.2019.09.002. Epub 2019 Oct 9.

  PMID: 31606309 DERIVED

Study Officials

• Oscar Penuelas, M.D.

  Hospital Universitario de Getafe, Madrid, Spain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oscar Penuelas, M.D.

CONTACT

+34-916834982; openuelas@gmail.com

Fernando Frutos Vivar, M.D.

CONTACT

+34-916834982; ffrutos@ucigetafe.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D

Study Record Dates

• First Submitted: April 4, 2016
• First Posted: April 8, 2016
• Study Start: April 28, 2020
• Primary Completion: June 30, 2020
• Study Completion: July 30, 2020
• Last Updated: April 29, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)