Momento óptimo para las pruebas de respiración espontánea
Impacto del momento de la prueba de respiración espontánea en los resultados en pacientes adultos con ventilación mecánica
This study aims to explore how the timing of Spontaneous Breathing Trials (SBTs) affects recovery in adult patients who are on mechanical ventilation in the ICU. SBTs are tests used to determine if a patient is ready to breathe on their own without the help of a ventilator. The study will compare two different timing strategies for these trials: one group of patients will have the test early in the morning, while the other group will have it later in the morning. By observing the outcomes, such as how long patients need to stay on the ventilator, the study hopes to find the best time to perform these trials to help patients recover more quickly and safely.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study seeks to understand how the timing of Spontaneous Breathing Trials (SBTs) impacts the recovery of adult patients who are on mechanical ventilation in the Intensive Care Unit (ICU). Mechanical ventilation is a life-support technique used for patients who are unable to breathe on their own. The Spontaneous Breathing Trial is a key step in assessing whether a patient is ready to breathe independently and can safely have the ventilator removed.
Currently, there is no universal standard for the best time of day to conduct these trials. Some hospitals perform SBTs early in the morning, while others wait until later in the morning when more staff are available. This study will compare two groups of patients: one group will have their SBTs early in the morning, and the other group will have them later.
The primary goal is to determine whether the timing of these trials affects how long patients need mechanical ventilation, how quickly they can be safely extubated (removal of the breathing tube), and overall recovery outcomes, such as ICU stay and hospital discharge.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: JIE LI, PhD
- Número de teléfono: 3125634643
- Correo electrónico: jie_li@rush.edu
Ubicaciones de estudio
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Illinois
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Chicago, Illinois, Estados Unidos, 60612
- Reclutamiento
- Rush University Medical Center
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Sub-Investigador:
- Lingyue Gong, MS
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Contacto:
- Jie Li, PhD
- Número de teléfono: 312-563-4643
- Correo electrónico: jie_li@rush.edu
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Adults aged 21 years or older.
- Patients who have been on mechanical ventilation for more than 48 hours.
- Patients who have completed at least one SBT.
Exclusion Criteria:
- Patients intubated at other hospitals.
- Patients intubated for surgical or interventional procedures.
- Patients receiving venovenous extracorporeal membrane oxygenation (VV-ECMO).
- Patients with a tracheostomy.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: Early morning timing of spontaneous breathing trial
Early Morning Group: Patients in this group will undergo their SBTs between 4:00 AM and 5:00 AM, following the traditional early morning schedule used in some ICUs. |
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Experimental: Later morning timing of spontaneous breathing trial
Later Morning Group: Patients in this group will have their SBTs scheduled between 8:00 AM and 9:00 AM, closer to the time of day shift rounds. |
Later Morning Group: Patients in this group will have their SBTs scheduled between 8:00 AM and 9:00 AM, closer to the time of day shift rounds. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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mechanical ventilation duration
Periodo de tiempo: From enrollment to the end of study at 28 days
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The primary outcome of this study is the duration of mechanical ventilation, which refers to the total number of days a patient remains on a mechanical ventilator in the ICU. This measure begins from the moment a patient is initially placed on the ventilator and continues until the patient is successfully extubated (the breathing tube is removed) and can breathe independently without the need for ventilatory support. |
From enrollment to the end of study at 28 days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Duration Between SBT Success and Extubation
Periodo de tiempo: From enrollment to the end of study at 28 days
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This outcome measures the time interval (in hours) between when a patient successfully passes a Spontaneous Breathing Trial (SBT) and when they are extubated. A successful SBT indicates that the patient is likely ready to breathe independently without mechanical support. |
From enrollment to the end of study at 28 days
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ICU and Hospital Mortality
Periodo de tiempo: From enrollment to the end of study at 28 days
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This outcome records the percentage of patients who die while in the ICU or during their overall hospital stay. |
From enrollment to the end of study at 28 days
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ICU and Hospital Lengths of Stay
Periodo de tiempo: From enrollment to the end of study at 28 days
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This outcome measures the total number of days a patient remains in the ICU and the hospital from admission to discharge. |
From enrollment to the end of study at 28 days
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Reintubation Rates
Periodo de tiempo: From enrollment to the end of study at 28 days
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This outcome measures the percentage of patients who require reintubation within 48 hours of being extubated. |
From enrollment to the end of study at 28 days
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Tracheostomy Rates
Periodo de tiempo: From enrollment to the end of study at 28 days
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This outcome records how often tracheostomy procedures are performed on patients who are unable to be weaned from mechanical ventilation via SBTs. A tracheostomy is a surgical procedure to create an opening through the neck into the trachea for long-term ventilatory support. |
From enrollment to the end of study at 28 days
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: JIE LI, PhD, Rush University
Publicaciones y enlaces útiles
Publicaciones Generales
- Ouellette DR, Patel S, Girard TD, Morris PE, Schmidt GA, Truwit JD, Alhazzani W, Burns SM, Epstein SK, Esteban A, Fan E, Ferrer M, Fraser GL, Gong MN, Hough CL, Mehta S, Nanchal R, Pawlik AJ, Schweickert WD, Sessler CN, Strom T, Kress JP. Liberation From Mechanical Ventilation in Critically Ill Adults: An Official American College of Chest Physicians/American Thoracic Society Clinical Practice Guideline: Inspiratory Pressure Augmentation During Spontaneous Breathing Trials, Protocols Minimizing Sedation, and Noninvasive Ventilation Immediately After Extubation. Chest. 2017 Jan;151(1):166-180. doi: 10.1016/j.chest.2016.10.036. Epub 2016 Nov 3.
- Roberts KJ. 2022 Year in Review: Ventilator Liberation. Respir Care. 2023 Nov 25;68(12):1728-1735. doi: 10.4187/respcare.11114.
- Jung B, Vaschetto R, Jaber S. Ten tips to optimize weaning and extubation success in the critically ill. Intensive Care Med. 2020 Dec;46(12):2461-2463. doi: 10.1007/s00134-020-06300-2. Epub 2020 Oct 26. No abstract available.
- Roberts KJ, Goodfellow LT, Battey-Muse CM, Hoerr CA, Carreon ML, Sorg ME, Glogowski J, Girard TD, MacIntyre NR, Hess DR. AARC Clinical Practice Guideline: Spontaneous Breathing Trials for Liberation From Adult Mechanical Ventilation. Respir Care. 2024 Jun 28;69(7):891-901. doi: 10.4187/respcare.11735.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 24081701
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Due to institution rule
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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