Ultra-Low Tidal Volume Mechanical Ventilation in ARDS Through ECMO

Ultra-Low Tidal Volume Mechanical Ventilation in ARDS Through ECMO (ULTIMATE) Pilot Randomized Trial

Patrocinadores

Patrocinador principal: University of Toronto

Colaborador: University Health Network, Toronto

Fuente University of Toronto
Resumen breve

Primary Research Question for the Full ULTIMATE Randomized Clinical Trial (RCT): What is the effect of ultra-protective ventilation facilitated by extracorporeal membrane oxygenation (ECMO) versus best current conventional ventilation (CV) on all-cause hospital mortality among patients with early moderate-severe acute respiratory distress syndrome (ARDS)? Secondary Research Questions: Among patients with early moderate-severe ARDS, what is the effect of ultra-protective ventilation versus CV on: (1) duration of mechanical ventilation; (2) duration of ICU and hospital stay; (3) organ dysfunction; (4) barotrauma; and (5) mortality at other time-points (ICU discharge, 28-day, 60-day)? The ULTIMATE Pilot Study: Before embarking on a definitive multinational trial to address the questions listed above, the ULTIMATE Pilot Study has these 3 specific feasibility objectives: 1. To assess adherence to our explicit mechanical ventilation protocols, with particular focus on delivered tidal volumes in both groups; 2. To estimate the rate of patient recruitment and understand barriers to recruitment; and 3. To measure and understand the reasons for crossovers or rescue by ECMO in the control group. In addition, we will monitor safety issues, recording serious adverse events in both groups.

Estado general Not yet recruiting
Fecha de inicio 2021-06-01
Fecha de Terminación 2023-12-01
Fecha de finalización primaria 2023-06-01
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Proportion of patients adhering to the study protocol Through study completion, an average of 2 years
Proportion of patients crossing over to VV ECMO Through study completion, an average of 2 years
Number of patients recruited for the study Through study completion, an average of 2 years
Resultado secundario
Medida Periodo de tiempo
Ventilator-free days Up to 30 days
Length of stay Through study completion, an average of 2 years
Number of patients with non-pulmonary organ dysfunction Up to 30 days
Number of patients with barotrauma Up to 30 days
Mortality Through study completion, an average of 2 years
Health-related quality of life At 6 months post-randomization
Inscripción 72
Condición
Intervención

Tipo de intervención: Device

Nombre de intervención: Venovenous ECMO

Descripción: Venovenous ECMO

Etiqueta de grupo de brazo: Ultra-protective ventilation with ECMO

Elegibilidad

Criterios:

Inclusion Criteria: 1. Age ≥ 18 years 2. Endotracheal mechanical ventilation for ≤ 5 days 3. Early moderate-severe ARDS (Berlin Definition) - all of the following conditions for ≤ 48 hours i. PaO2/FiO2 ≤200 with PEEP > 5 cmH2O ii. bilateral opacities not fully explained by effusions, lobar/lung collapse, or nodules iii. respiratory failure not fully explained by cardiac failure or fluid overload iv. within one week of a known insult of new or worsening respiratory symptoms 4. ARDS severity criterion - either 1 of: 1. PaO2/FiO2 ≤ 150 mm Hg, on PEEP ≥ 10 cm H2O and FiO2 ≥ 0.5 Exclusion Criteria: 1. Currently receiving any form of ECMO (e.g., venovenous, venoarterial, or hybrid configuration) 2. Chronic hypercapnic respiratory failure defined as PaCO2 > 60 mmHg in the outpatient setting 3. Home mechanical ventilation (non-invasive ventilation or via tracheotomy), not CPAP 4. Actual body weight exceeding 1 kg per centimeter of height 5. Severe hypoxemia with PaO2/FiO2 < 80 mmHg 6. Expected mechanical ventilation duration < 48 hours 7. Treating team is in the process of moving to a palliative mode of care 8. Moribund patient not expected to survive 24 hours despite ongoing life-sustaining therapies 9. Confirmed diffuse alveolar hemorrhage from vasculitis 10. Contraindications to limited anticoagulation (e.g., active GI bleeding, bleeding diathesis) 11. Pregnancy - due to unknown effects of PaCO2 changes on placental blood flow

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: No

Oficial general
Contacto general

Apellido: Kathleen Exconde

Teléfono: 416-340-4800

Teléfono Ext.: 5519

Email: [email protected]

Ubicación
Instalaciones: Contacto: Investigador:
New York Presbyterian Hospital | New York, New York, 10032, United States TBA Daniel Brodie, MD Principal Investigator
OHSU Hospital | Portland, Oregon, 97239, United States TBA Terri Hough, MD, MSc Principal Investigator
University of Alberta Hospital | Edmonton, Alberta, Canada TBA Sean Bagshaw, MD, MSc Principal Investigator
London Health Sciences Centre | London, Ontario, Canada TBA Karen Bosma, MD Principal Investigator Dave Nagpal, MD Principal Investigator
University of Ottawa | Ottawa, Ontario, Canada TBA Andrew Seely, MD Principal Investigator Bernard McDonald, MD Principal Investigator
Mount Sinai Hospital | Toronto, Ontario, M5G 1X5, Canada TBA Laveena Munshi, MD, MSc Principal Investigator
University Health Network - Toronto General Hospital | Toronto, Ontario, M5G 2N2, Canada Kathleen Exconde 416-340-4800 5519 [email protected] Shaf Keshavjee, MD, MSc Sub-Investigator Marcelo Cypel, MD, MSc Sub-Investigator Lorenzo Del Sorbo, MD Sub-Investigator Ewan Goligher, MD, PhD Sub-Investigator
Sunnybrook Health Sciences Centre | Toronto, Ontario, Canada TBA Neill Adhikari, MD, MSc Principal Investigator
Unity Health | Toronto, Ontario, Canada TBA Laurent Brochard, MD Principal Investigator Jan Friedrich, MD, PhD Principal Investigator
University Health Network - Toronto Western Hospital | Toronto, Ontario, Canada TBA Elizabeth Wilcox, MD, PhD Principal Investigator
Centre Hospitalier Universitaire de Sherbrooke | Sherbrooke, Quebec, Canada TBA Francois Lamotagne, MD, MSc Principal Investigator
Ubicacion Paises

Canada

United States

Fecha de verificación

2021-04-01

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: University of Toronto

Nombre completo del investigador: Eddy Fan

Título del investigador: Associate Professor

Palabras clave
Tiene acceso ampliado No
Número de brazos 2
Grupo de brazo

Etiqueta: Best conventional ventilation

Tipo: No Intervention

Etiqueta: Ultra-protective ventilation with ECMO

Tipo: Experimental

Acrónimo ULTIMATE
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov

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