Global BurdEn of MechanIcal VeNtilatIon (GEMINI). VeNtilatIon (GEMINI Study) 2022 for VENTILAGROUP.

NCT05392010 | Recruiting DMC

• 1 other identifier: GEMINI/0422
• Study Type: observational
• Target: 10,900
• Locations: 1 country
• Sites: 1

Brief Summary

BACKGROUND: Changes in the clinical practice of mechanical ventilation during and after the coronavirus pandemic (COVID-19) worldwide could influence the clinical outcomes of critically ill patients with mechanical ventilation due to a generalization of these changes. Thus, the variability of the clinical response of different strategies in critically ill patients could be related to the existence of unidentified phenotypes that would be related to an increased risk of mortality and functional deterioration at the medium term. OBJECTIVES: The main objective will be to evaluate the worldwide clinical practice of mechanical Ventilation in critically ill patients, as well as the medium-term clinical outcomes for the description of phenotypes of critically ill patients treated with mechanical ventilation. The analysis of phenotypes and unsupervised pattern recognition over time could help to predict relevant clinical outcomes. This approach could improve personalized and precision medicine applicable to the ventilated patient. METHODOLOGY: An observational, prospective, non-interventional, international, and multicenter study will be carried out that will include adult critically ill patients requiring invasive or non-invasive mechanical ventilation for more than 12 hours. Analyzes of the variability of mortality and functional impairment at six months will be performed. Likewise, artificial intelligence analyzes ("machine learning" and "neural networks") will be carried out.

Conditions

Mechanical Ventilation; Usual Care; Noninvasive Positive Pressure Ventilation; High Flow Oxygen Therapy

Keywords

mechanical ventilation; mortality; clinical variability; precision medicine; critical illness; frailty; acute respiratory failure

Outcome Measures

Primary Outcomes (1)

• ICU mortality

  rate of dead patients requiring mechanical ventilation during ICU stay

  From date of inclusion until the date of death from any cause during ICU stay, whichever came first, assessed up to 6 weeks

Secondary Outcomes (12)

• hospital mortality.

  From date of inclusion until the date of death from any cause during hospital stay, whichever came first, assessed up to 6 months

• duration of mechanical ventilation.

  from orotracheal intubation date until scheduled extubation date or 24 hours of unassisted respiratory support in tracheotomized patietns

• 28-day mortality.

  from initiacion from mechanical ventilation until 28-day hospital stay.

• 6 months mortality

  from hospital discharge date until 6 months of follow-up in surviors from ICU stay.

• 6-months frailty.

  from hospital discharge date until 6 months of follow-up in surviors from ICU stay, assessed by Clinical Frailty Scale (CFS, where values between 1-9 points, a higher scores mean a worse outcome)

Study Arms (1)

ventilated critically ill patients

All consecutive adult patients (≥ 18 years old) who are admitted to the ICU and require invasive mechanical ventilation (endotracheal tube or tracheostomy) longer than 12 hours. 2. Adult patients admitted to the ICU and require advanced respiratory support (high flow oxygen nasal cannula \[HFONC\], or noninvasive ventilation \[NIV\] BIPAP or CPAP with oronasal, nasal, helmet or facial mask) with acute respiratory failure defined as PaO2/ fraction of inspired oxygen (FiO2), \[PaO2/FiO2\] ratio \<300, or the pulse oximetric saturation (SpO2/FiO2 ) ratio \< 315 for more than 1 hour.

Other: no intervention

Interventions

no intervention OTHER

no intervention

ventilated critically ill patients

Eligibility Criteria

• Age: 18 Years - 119 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 participants from different regions and countries and being comparable between them, the Steering Committee will create some clinical operative definitions for the selection of the participating ICUs from each region.The study population will be adult critically ill patients with acute respiratory failure and need of ventilatory support (inv asive or noninvasive oxigenation support, including high flow oxygen therapy or noninvasive ventilation).

You may qualify if:

• All consecutive adult patients (≥ 18 years old) who are admitted to the ICU and require invasive mechanical ventilation (endotracheal tube or tracheostomy) longer than 12 hours. 2. Adult patients admitted to the ICU and require advanced respiratory support (high flow oxygen nasal cannula \[HFONC\], or noninvasive ventilation \[NIV\] BIPAP or CPAP with oronasal, nasal, helmet or facial mask) with acute respiratory failure defined as PaO2/ fraction of inspired oxygen (FiO2), \[PaO2/FiO2\] ratio \<300, or the pulse oximetric saturation (SpO2/FiO2 ) ratio \< 315 for more than 1 hour. 3. Adult patients in whom mechanical ventilation were started outside the study ICU at the same Institution and/or a different Institution, including Emergency Room, Operating Room (OR), /or were then transferred to the ICU at the participating center

You may not qualify if:

• The following ICUs will be excluded:
• Pediatric ICU.
• Post-Operators Anesthesia Recovery Room. 2. Patients less than 18 years old. 3. Patients admitted after elective surgery and who require mechanical ventilation for less than 12 hours (excepting patients who receive non-invasive ventilation). 4. Patients will be excluded if they were transferred to participating ICUs without a documented intubation time, or underwent a tracheotomy at prior to ICU admission. 5. Patients that were at participating ICUs for 24 hours or more, were readmitted during the study period

Sponsors & Collaborators

• Hospital Universitario Getafe: lead
• Spanish Research Center for Respiratory Diseases: collaborator

Study Sites (1)

Intensive Care Unit, Hospital Universitario de Getafe

Getafe, Madrid, 28905, Spain

RECRUITING

Related Publications (17)

• Wunsch H, Linde-Zwirble WT, Angus DC, Hartman ME, Milbrandt EB, Kahn JM. The epidemiology of mechanical ventilation use in the United States. Crit Care Med. 2010 Oct;38(10):1947-53. doi: 10.1097/CCM.0b013e3181ef4460.

  PMID: 20639743 BACKGROUND

• Carson SS, Cox CE, Holmes GM, Howard A, Carey TS. The changing epidemiology of mechanical ventilation: a population-based study. J Intensive Care Med. 2006 May-Jun;21(3):173-82. doi: 10.1177/0885066605282784.

  PMID: 16672639 BACKGROUND

• Rubenfeld GD, Caldwell E, Peabody E, Weaver J, Martin DP, Neff M, Stern EJ, Hudson LD. Incidence and outcomes of acute lung injury. N Engl J Med. 2005 Oct 20;353(16):1685-93. doi: 10.1056/NEJMoa050333.

  PMID: 16236739 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Wunsch H, Wagner J, Herlim M, Chong DH, Kramer AA, Halpern SD. ICU occupancy and mechanical ventilator use in the United States. Crit Care Med. 2013 Dec;41(12):2712-9. doi: 10.1097/CCM.0b013e318298a139.

  PMID: 23963122 BACKGROUND

• 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 BACKGROUND

• Vincent JL, Sakr Y, Ranieri VM. Epidemiology and outcome of acute respiratory failure in intensive care unit patients. Crit Care Med. 2003 Apr;31(4 Suppl):S296-9. doi: 10.1097/01.CCM.0000057906.89552.8F.

  PMID: 12682455 BACKGROUND

• Adhikari NK, Fowler RA, Bhagwanjee S, Rubenfeld GD. Critical care and the global burden of critical illness in adults. Lancet. 2010 Oct 16;376(9749):1339-46. doi: 10.1016/S0140-6736(10)60446-1. Epub 2010 Oct 11.

  PMID: 20934212 BACKGROUND

• Vincent JL, Marshall JC, Namendys-Silva SA, Francois B, Martin-Loeches I, Lipman J, Reinhart K, Antonelli M, Pickkers P, Njimi H, Jimenez E, Sakr Y; ICON investigators. Assessment of the worldwide burden of critical illness: the intensive care over nations (ICON) audit. Lancet Respir Med. 2014 May;2(5):380-6. doi: 10.1016/S2213-2600(14)70061-X. Epub 2014 Apr 14.

  PMID: 24740011 BACKGROUND

• Grasselli G, Zangrillo A, Zanella A, Antonelli M, Cabrini L, Castelli A, Cereda D, Coluccello A, Foti G, Fumagalli R, Iotti G, Latronico N, Lorini L, Merler S, Natalini G, Piatti A, Ranieri MV, Scandroglio AM, Storti E, Cecconi M, Pesenti A; COVID-19 Lombardy ICU Network. Baseline Characteristics and Outcomes of 1591 Patients Infected With SARS-CoV-2 Admitted to ICUs of the Lombardy Region, Italy. JAMA. 2020 Apr 28;323(16):1574-1581. doi: 10.1001/jama.2020.5394.

  PMID: 32250385 BACKGROUND

• Reddy K, Sinha P, O'Kane CM, Gordon AC, Calfee CS, McAuley DF. Subphenotypes in critical care: translation into clinical practice. Lancet Respir Med. 2020 Jun;8(6):631-643. doi: 10.1016/S2213-2600(20)30124-7.

  PMID: 32526190 BACKGROUND

• Shah FA, Meyer NJ, Angus DC, Awdish R, Azoulay E, Calfee CS, Clermont G, Gordon AC, Kwizera A, Leligdowicz A, Marshall JC, Mikacenic C, Sinha P, Venkatesh B, Wong HR, Zampieri FG, Yende S. A Research Agenda for Precision Medicine in Sepsis and Acute Respiratory Distress Syndrome: An Official American Thoracic Society Research Statement. Am J Respir Crit Care Med. 2021 Oct 15;204(8):891-901. doi: 10.1164/rccm.202108-1908ST.

  PMID: 34652268 BACKGROUND

• Higgins AM, Neto AS, Bailey M, Barrett J, Bellomo R, Cooper DJ, Gabbe BJ, Linke N, Myles PS, Paton M, Philpot S, Shulman M, Young M, Hodgson CL; PREDICT Study Investigators. Predictors of death and new disability after critical illness: a multicentre prospective cohort study. Intensive Care Med. 2021 Jul;47(7):772-781. doi: 10.1007/s00134-021-06438-7. Epub 2021 Jun 5.

  PMID: 34089063 BACKGROUND

• Hodgson CL, Udy AA, Bailey M, Barrett J, Bellomo R, Bucknall T, Gabbe BJ, Higgins AM, Iwashyna TJ, Hunt-Smith J, Murray LJ, Myles PS, Ponsford J, Pilcher D, Walker C, Young M, Cooper DJ. The impact of disability in survivors of critical illness. Intensive Care Med. 2017 Jul;43(7):992-1001. doi: 10.1007/s00134-017-4830-0. Epub 2017 May 22.

  PMID: 28534110 BACKGROUND

• Needham DM, Davidson J, Cohen H, Hopkins RO, Weinert C, Wunsch H, Zawistowski C, Bemis-Dougherty A, Berney SC, Bienvenu OJ, Brady SL, Brodsky MB, Denehy L, Elliott D, Flatley C, Harabin AL, Jones C, Louis D, Meltzer W, Muldoon SR, Palmer JB, Perme C, Robinson M, Schmidt DM, Scruth E, Spill GR, Storey CP, Render M, Votto J, Harvey MA. Improving long-term outcomes after discharge from intensive care unit: report from a stakeholders' conference. Crit Care Med. 2012 Feb;40(2):502-9. doi: 10.1097/CCM.0b013e318232da75.

  PMID: 21946660 BACKGROUND

• COVID-ICU Group on behalf of the REVA Network and the COVID-ICU Investigators. Clinical characteristics and day-90 outcomes of 4244 critically ill adults with COVID-19: a prospective cohort study. Intensive Care Med. 2021 Jan;47(1):60-73. doi: 10.1007/s00134-020-06294-x. Epub 2020 Oct 29.

  PMID: 33211135 BACKGROUND

MeSH Terms

Conditions

Critical Illness; Frailty

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Oscar Penuelas, P.h.D

  Hospital Universitario de Getafe, Madrid, Spain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Óscar Penuelas, P.h.D

CONTACT

+34916834982; openuelas@gmail.com

Fernando Frutos-Vivar, M.D

CONTACT

+34916834982; fernando.frutos@salud.madrid.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator. Clinical Chief Intensive Care Unit

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 26, 2022
• Study Start: October 1, 2022
• Primary Completion: March 1, 2024
• Study Completion: September 30, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)