Multicenter Observational Study on Practice of Ventilation in Brain Injured Patients

NCT04459884 | Completed DMC

• 1 other identifier: VENTIBRAIN
• Study Type: observational
• Target: 2,299
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale Several experimental and clinical studies have shown how brain injury can cause secondary lung injury. Lung injury could be due either to mechanical ventilation- often necessary in brain injured patients- or to inflammatory response that follows primary acute brain injury. The concept of 'Protective lung ventilation' has shown to reduce morbidity and mortality of intensive care unit (ICU) patients with acute respiratory distress syndrome (ARDS) but seems also to have a beneficial effect on patients with healthy lungs and in the perioperative settings. However, these recommendations often come into conflict with the management of patients affected by acute brain injury, in which permissive hypercapnia and increased intrathoracic pressure as consequence of protective ventilation strategies can be dangerous. Study design This is an international multi-center prospective observational study. Study population This study will include all consecutive brain injured patients (traumatic brain injury (TBI) or cerebrovascular) intubated and ventilated in ICU and observed for a 7-day period. Nature and extent of the burden and risks associated with participation, benefit and group relatedness Seen the observational design of the study, there is no patient burden. Collection of data from ICU and hospital charts and/or (electronic) medical records systems is of no risk to patients.

Conditions

Mechanical Ventilation; Acute Brain Injury

Outcome Measures

Primary Outcomes (1)

• Description of different ventilatory strategies applied to acutely brain injured patients admitted to the ICUs

  We will compare the different ventilatory approaches to intubated and mechanically ventilated neurocritically ill patients admitted to worldwide ICUs.

  12 months

Secondary Outcomes (4)

• Correlation between ventilatory targets and neurological outcome at ICU discharge and after 6 months from admission

  12 months

• Description of different ventolatory approaches to nuerocritically-ill patients

  12 months

• Description of mechanical ventilation-associated complication

  12 months

• Correlation between ventilatory targets and neurological secondary injury

  12 months

Interventions

mechanical ventilation PROCEDURE

mechanical ventilation \> 48h

Eligibility Criteria

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

Study Population

We will collect data of consecutive patients with acute brain injury intubated and ventilated, admitted to the intensive care unit (ICU).

You may qualify if:

• Adult patients admitted to the ICU with a diagnosis of
• traumatic brain injury or
• cerebrovascular diseases (intracranial hemorrhage, subarachnoid hemorrhage, ischemic stroke)
• Patients requiring intubation and mechanical ventilation in the ICU
• Expected ventilation for more than 48 hours

You may not qualify if:

• Age \< 18 years
• Pregnant patients
• Patients not intubated or not mechanically ventilated or receiving only non-invasive ventilation (i.e., the patient never received invasive ventilation during the present admission)
• Expected ventilation or death\< 48 hours

Sponsors & Collaborators

• University of Milano Bicocca: lead

Study Sites (1)

ASST-Monza

Monza, MB, 20900, Italy

Location

Related Publications (14)

• Slutsky AS. Lung injury caused by mechanical ventilation. Chest. 1999 Jul;116(1 Suppl):9S-15S. doi: 10.1378/chest.116.suppl_1.9s-a. No abstract available.

  PMID: 10424561 RESULT

• Putensen C, Theuerkauf N, Zinserling J, Wrigge H, Pelosi P. Meta-analysis: ventilation strategies and outcomes of the acute respiratory distress syndrome and acute lung injury. Ann Intern Med. 2009 Oct 20;151(8):566-76. doi: 10.7326/0003-4819-151-8-200910200-00011.

  PMID: 19841457 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

• Matthay MA, Ware LB, Zimmerman GA. The acute respiratory distress syndrome. J Clin Invest. 2012 Aug;122(8):2731-40. doi: 10.1172/JCI60331. Epub 2012 Aug 1.

  PMID: 22850883 RESULT

• Needham DM, Colantuoni E, Mendez-Tellez PA, Dinglas VD, Sevransky JE, Dennison Himmelfarb CR, Desai SV, Shanholtz C, Brower RG, Pronovost PJ. Lung protective mechanical ventilation and two year survival in patients with acute lung injury: prospective cohort study. BMJ. 2012 Apr 5;344:e2124. doi: 10.1136/bmj.e2124.

  PMID: 22491953 RESULT

• Dellinger RP, Levy MM, Rhodes A, Annane D, Gerlach H, Opal SM, Sevransky JE, Sprung CL, Douglas IS, Jaeschke R, Osborn TM, Nunnally ME, Townsend SR, Reinhart K, Kleinpell RM, Angus DC, Deutschman CS, Machado FR, Rubenfeld GD, Webb S, Beale RJ, Vincent JL, Moreno R; Surviving Sepsis Campaign Guidelines Committee including The Pediatric Subgroup. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock, 2012. Intensive Care Med. 2013 Feb;39(2):165-228. doi: 10.1007/s00134-012-2769-8. Epub 2013 Jan 30.

  PMID: 23361625 RESULT

• Determann RM, Royakkers A, Wolthuis EK, Vlaar AP, Choi G, Paulus F, Hofstra JJ, de Graaff MJ, Korevaar JC, Schultz MJ. Ventilation with lower tidal volumes as compared with conventional tidal volumes for patients without acute lung injury: a preventive randomized controlled trial. Crit Care. 2010;14(1):R1. doi: 10.1186/cc8230. Epub 2010 Jan 7.

  PMID: 20055989 RESULT

• Serpa Neto A, Cardoso SO, Manetta JA, Pereira VG, Esposito DC, Pasqualucci Mde O, Damasceno MC, Schultz MJ. Association between use of lung-protective ventilation with lower tidal volumes and clinical outcomes among patients without acute respiratory distress syndrome: a meta-analysis. JAMA. 2012 Oct 24;308(16):1651-9. doi: 10.1001/jama.2012.13730.

  PMID: 23093163 RESULT

• Neto AS, Barbas CSV, Simonis FD, Artigas-Raventos A, Canet J, Determann RM, Anstey J, Hedenstierna G, Hemmes SNT, Hermans G, Hiesmayr M, Hollmann MW, Jaber S, Martin-Loeches I, Mills GH, Pearse RM, Putensen C, Schmid W, Severgnini P, Smith R, Treschan TA, Tschernko EM, Melo MFV, Wrigge H, de Abreu MG, Pelosi P, Schultz MJ; PRoVENT; PROVE Network investigators. Epidemiological characteristics, practice of ventilation, and clinical outcome in patients at risk of acute respiratory distress syndrome in intensive care units from 16 countries (PRoVENT): an international, multicentre, prospective study. Lancet Respir Med. 2016 Nov;4(11):882-893. doi: 10.1016/S2213-2600(16)30305-8. Epub 2016 Oct 4.

  PMID: 27717861 RESULT

• Carney N, Totten AM, O'Reilly C, Ullman JS, Hawryluk GW, Bell MJ, Bratton SL, Chesnut R, Harris OA, Kissoon N, Rubiano AM, Shutter L, Tasker RC, Vavilala MS, Wilberger J, Wright DW, Ghajar J. Guidelines for the Management of Severe Traumatic Brain Injury, Fourth Edition. Neurosurgery. 2017 Jan 1;80(1):6-15. doi: 10.1227/NEU.0000000000001432.

  PMID: 27654000 RESULT

• Picetti E, Pelosi P, Taccone FS, Citerio G, Mancebo J, Robba C; on the behalf of the ESICM NIC/ARF sections. VENTILatOry strategies in patients with severe traumatic brain injury: the VENTILO Survey of the European Society of Intensive Care Medicine (ESICM). Crit Care. 2020 Apr 17;24(1):158. doi: 10.1186/s13054-020-02875-w.

  PMID: 32303255 RESULT

• Gajic O, Dabbagh O, Park PK, Adesanya A, Chang SY, Hou P, Anderson H 3rd, Hoth JJ, Mikkelsen ME, Gentile NT, Gong MN, Talmor D, Bajwa E, Watkins TR, Festic E, Yilmaz M, Iscimen R, Kaufman DA, Esper AM, Sadikot R, Douglas I, Sevransky J, Malinchoc M; U.S. Critical Illness and Injury Trials Group: Lung Injury Prevention Study Investigators (USCIITG-LIPS). Early identification of patients at risk of acute lung injury: evaluation of lung injury prediction score in a multicenter cohort study. Am J Respir Crit Care Med. 2011 Feb 15;183(4):462-70. doi: 10.1164/rccm.201004-0549OC. Epub 2010 Aug 27.

  PMID: 20802164 RESULT

• ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.

  PMID: 22797452 RESULT

• Robba C, Citerio G, Taccone FS, Galimberti S, Rebora P, Vargiolu A, Pelosi P; VENTIBRAIN Enlarged Steering committee members; VENTIBRAIN. Multicentre observational study on practice of ventilation in brain injured patients: the VENTIBRAIN study protocol. BMJ Open. 2021 Aug 11;11(8):e047100. doi: 10.1136/bmjopen-2020-047100.

  PMID: 34380722 DERIVED

MeSH Terms

Conditions

Brain Injuries

Interventions

Respiration, Artificial

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Resuscitation; Emergency Treatment; Respiratory Therapy

Study Officials

• Chiara Robba, MD

  University of Milano Bicocca

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: July 7, 2020
• Study Start: August 23, 2021
• Primary Completion: September 12, 2024
• Study Completion: September 12, 2024
• Last Updated: March 25, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)