The NEUROlogically-impaired Extubation Timing Trial (NEURO-ETT)
3 de febrero de 2020 actualizado por: Dr. Damon Scales, Sunnybrook Health Sciences Centre
This randomized controlled trial will enrol patients with acute severe brain injury who pass a spontaneous breathing trial but have decreased level of consciousness.
It will directly compare (1) prompt extubation vs. (2) usual care, with extubation or tracheostomy timed according to physicians' discretion.
The primary outcome will be ICU free days (days spent alive and outside an ICU).
Descripción general del estudio
Estado
Desconocido
Condiciones
Intervención / Tratamiento
Descripción detallada
Thousands of patients suffer severe brain injuries every year, from causes such as trauma, stroke, and infection.
Extensive clinical research in weaning from mechanical ventilation has led to recommendations for prompt extubation following a successful trial of spontaneous breathing in general intensive care unit (ICU).
However, little evidence exists to guide decisions about when to remove the breathing tube in patients with severe brain injury.
It is unclear which of the following strategies would optimize important patient outcomes: prompt extubation vs. waiting and extubating or performing a tracheostomy, timed according to physicians' discretion.
Each strategy has associated risks: prompt extubation may lead to higher rates of extubation failure and reintubation, whereas waiting longer may expose patients to complications from prolonged mechanical ventilation and tracheostomy may lead to procedural complications (or unnecessary procedures, if prompt extubation would be successful).
This trial in brain-injured patients will test which of the following will lead to better patient outcomes: (1) removing the endotracheal tube promptly once a spontaneous breathing trial is passed; or (2) usual care, with the airway management strategy selected according to the preference of the treating physician.
Tipo de estudio
Intervencionista
Inscripción (Actual)
27
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Alberta
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Edmonton, Alberta, Canadá, T6G 2B7
- University of Alberta Hospital
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British Columbia
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New Westminster, British Columbia, Canadá, V3L 3W7
- Royal Columbian Hospital
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Vancouver, British Columbia, Canadá, V5Z 1M9
- Vancouver General Hospital
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Ontario
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Hamilton, Ontario, Canadá, L8N 3Z5
- Hamilton General Hospital
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Kingston, Ontario, Canadá, K7L 2V7
- Kingston General Hospital
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London, Ontario, Canadá, N6A 5A5
- London Health Sciences Centre
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Ottawa, Ontario, Canadá, K1H 8L6
- Ottawa Hospital
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Toronto, Ontario, Canadá, M4N 3M5
- Sunnybrook Health Sciences Centre
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Toronto, Ontario, Canadá, M5B 1W8
- St. Michael's Hospital
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Toronto, Ontario, Canadá, M5G 2N2
- Toronto Western Hospital
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Quebec
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Montreal, Quebec, Canadá, H4J 1C5
- Hopital du Sacre-Coeur de Montreal
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Montreal, Quebec, Canadá, H2X 2H8
- Centre Hospitalier de l'Université de Montréal
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Quebec City, Quebec, Canadá, G1J 1Z4
- L'Hôpital de l'Enfant-Jésus
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
16 años y mayores (Niño, Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Age > 16 years
- Acute brain injury (subarachnoid hemorrhage, ischemic stroke, spontaneous intracerebral hemorrhage, seizure, traumatic brain injury, brain tumor, global cerebral anoxia/cardiac arrest, meningitis/encephalitis/cerebral abscess) that occurred within the previous 4 weeks.
- Receiving invasive mechanical ventilation via endotracheal tube for > 72 hours
- Glasgow Coma Scale motor score 3 to 6 with improvement or no change from previous day
- passed spontaneous breathing trial (SBT)
Exclusion Criteria:
- Previous extubation during this ICU admission
- Quadriplegic
- Neuromuscular disease that will result in prolong need for mechanical ventilation, including but not limited to Guillain-Barre syndrome, cervical spinal cord injury, advanced multiple sclerosis
- Do-Not-Reintubate order in place
- Previously randomized in this trial
- Underlying pre-existing condition with expected mortality less than 6-months.
- Anticipated/scheduled for surgical procedures within 48 hours
- C-spine not yet cleared for activity as tolerated (cleared for activity as tolerated while wearing hard collar is acceptable)
- Currently known or suspected to have an difficult airway
- Absence of an endotracheal tube cuff leak, if checked
- Absence of spontaneous or induced cough
- Current enrolment in an RCT that precludes NEURO-ETT co-enrollment
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Extubation
Extubation by removal of endotracheal tube.
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This is an extubation by removal of endotracheal tube which must be done on the day of randomization or the following day.
Any decision to subsequently reintubate the patient will be left to the discretion of the clinical team.
Similarly, if a tracheostomy is deemed necessary in a patient who fails the extubation attempt, this will be managed at the discretion of the treating team.
If for any reason the patient is not extubated according to the randomized schedule, the reason(s) will be recorded on a protocol violation form and the site investigator will be notified.
If a patient receives a tracheostomy instead of being extubated we will again record reasons for this, but the patient will be analysed in the extubation group according to the intention-to-treat principle.
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Comparador activo: Usual care
The usual clinical practice is removal of the endotracheal tube (extubation), or insertion of tracheostomy, timed according to physicians' discretion
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Patients in this group will be treated according to usual care, which may include extubation (removal of endotracheal tube) or insertion of a tracheostomy, timed according to physicians' discretion.
The inclusion of this arm will allow prompt extubation to be compared to usual practice, which often involves further observation and delayed decision-making due to clinician uncertainty about the optimal airway management strategy.
Incorporation of usual care arms has been promoted as a design feature to improve the safety and interpretability of critical care clinical trials.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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ICU Free Days
Periodo de tiempo: 60 days
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The primary outcome is number of ICU free days to day 60, defined as the number of days spent alive and outside of an ICU until day 60. The primary outcome will be measured to answer the following primary question: Among patients receiving minimal mechanical ventilatory support for severe and persistent brain injury, which of the following airway management strategies increase ICU-free days to day 60: (1) prompt extubation vs. (2) usual care, which may include extubation or tracheostomy timed according to physicians' discretion? |
60 days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Mortality,
Periodo de tiempo: up to 6 months
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Mortality at ICU discharge, mortality at hospital discharge, mortality at 3 months, mortality at 6 months
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up to 6 months
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Ventilator-Free Days
Periodo de tiempo: up to 60 days
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Days free of mechanical ventilation, total duration (days) of ventilation among survivors
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up to 60 days
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Airway Complications
Periodo de tiempo: up to 60 days
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Presence versus absence of airway complication
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up to 60 days
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Nutrition Intake
Periodo de tiempo: up to 6 months
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Time to normal oral nutrition intake
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up to 6 months
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Antibiotic Days
Periodo de tiempo: up to day 14
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Injection or infusion of antibiotics given intravenously
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up to day 14
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Delirium
Periodo de tiempo: up to day 14
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Presence versus absence of delirium experienced
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up to day 14
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Rate of Tracheostomy Insertion
Periodo de tiempo: up to 6 months
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Presence versus absence of tracheostomy insertion
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up to 6 months
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Rate of ICU Readmission
Periodo de tiempo: up to hospital discharge
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ICU readmission rates to hospital discharge
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up to hospital discharge
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Hospital Discharge Destination
Periodo de tiempo: at hospital discharge
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Destination of the patient post hospitalization - home, rehabilitation facility, retirement home, long-term care/nursing home, no fixed address or shelter, continuing complex care, acute care hospital, other
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at hospital discharge
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Extended Glasgow Outcome Score
Periodo de tiempo: up to 6 months
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Functional outcome (scoring 1 to 8)
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up to 6 months
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EQ-5D
Periodo de tiempo: up to 6 months
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Health related quality of life (scoring 1 to 5)
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up to 6 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Damon Scales, MD, PhD, Sunnybrook Health Sciences Centre
- Investigador principal: Niall Ferguson, MD, MSc,, Toronto General Hospital
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de febrero de 2017
Finalización primaria (Actual)
19 de junio de 2019
Finalización del estudio (Anticipado)
31 de enero de 2022
Fechas de registro del estudio
Enviado por primera vez
22 de septiembre de 2016
Primero enviado que cumplió con los criterios de control de calidad
28 de septiembre de 2016
Publicado por primera vez (Estimar)
30 de septiembre de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
5 de febrero de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
3 de febrero de 2020
Última verificación
1 de febrero de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NEURO-ETT (Vanguard)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Lesión cerebral aguda
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