Effectiveness of Inspiratory Muscle Training in Weaning ICU Patients (IMT in weaning)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
It is estimated that 40% of the duration of mechanical ventilation is devoted to the weaning process. A length of stay in the ICU of more than 7 days appears to be associated with a 27,9% risk of developing infections. Furthermore, the mortality rate is higher in patients with infections. Additionally, the daily cost of hospitalizing a patient on mechanical ventilation is estimated at €1,590-€1,657, while this varies depending on the interventions required. The burden on the National Health System from the prolonged stay of patients in the ICU, as well as from the complications that will arise, increases exponentially.
It has been found that implementing an IMT program can lead to rapid and successful extubation of the patient, while early mobilization can accelerate timely discharge from the ICU. This optimizes the cost-effectiveness ratio in intensive care units.
The investigators believe that implementing an IMT program will maximize the effectiveness of the early mobilization program for ICU patients. Thus, the investigators believe it will provide valuable insights into the rehabilitation needs of critically ill patients, contributing to earlier weaning from mechanical ventilation and transition to the next level of care. The investigators hypothesize that the implementation of such an intervention program will reduce the length of hospital stay, while also lowering the cost of daily care.
This is a randomized control trial that investigates the effectiveness of an inspiratory muscle training program in successful weaning of mechanically ventilated patients for at least 72 hours. Both experimental groups will receive a protocolised early mobilization program. IMT intervention will be applied till ICU discharge once a day for 5 days/week initiating with a load of 40% of maximal inspiratory pressure (MIP). Primary outcome will be a successful weaning from MV. And secondary includes MV duration, MIP, maximal expiratory pressure (MEP), ICU and hopsital length of stay.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: IRINI PATSAKI, PhD
- Número de teléfono: +30 6942064363
- Correo electrónico: ipatsaki@uniwa.gr
Ubicaciones de estudio
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Chalcis, Grecia
- Reclutamiento
- General Hospital
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Contacto:
- Stiliani Andreadou, MSc
- Número de teléfono: +306942064363
- Correo electrónico: s.andreadou@gmail.com
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Nikaia, Grecia
- Reclutamiento
- General Hospital "Agios Panteleimon"
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Contacto:
- Stavroula Fokidi, MSc
- Número de teléfono: +306942064363
- Correo electrónico: sfokidi@uniwa.gr
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Investigador principal:
- Stavroula Fokidi, MSc
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- ≥ 72h invasive mechanical ventilation
- adequate co-operativeness as assessed by 5SQ ≥ 3.
Exclusion Criteria:
- terminal condition or palliative care
- neuromuscular or neurological conditions prior to ICU admission
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: IMT Group
Inspiratory muscle training will be performed using an electronic breathing trainer (40% of MIP, with a daily increase of 10% of the initial MIP) and 30 repetitions, organized into 3 sets of 10 repetitions with a 1-minute break between sets. Additional, a protocolized early mobilization program will be perfromed. |
Inspiratory muscle training will be performed using an electronic breathing trainer (40% of MIP, with a daily increase of 10% of the initial MIP) and 30 repetitions, organized into 3 sets of 10 repetitions with a 1-minute break between sets
Protocolized early mobilization program
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Comparador activo: Control Group
A protocolized early mobilization program
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Protocolized early mobilization program
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Weaning sucess
Periodo de tiempo: immediately after intervention
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Successful weaning is defined as the removal of the endotracheal tube with no ventilator support for 48 hours following its removal
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immediately after intervention
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Weaning duration
Periodo de tiempo: immediately after intervention
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Duration of weaning procedure
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immediately after intervention
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Maximal Inspiratory Pressure
Periodo de tiempo: 1st day (baseline), immediately after intervention
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Maximal inspiratory Pressure
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1st day (baseline), immediately after intervention
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Maximal expirartory pressure
Periodo de tiempo: 1st day (baseline), immediately after intervention
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1st day (baseline), immediately after intervention
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 77916
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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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