Computed Inspiratory Muscle Pressure to Monitor Inspiratory Effort During Pressure Support Ventilation
Validation of Computed Inspiratory Muscle Pressure to Monitor Inspiratory Effort During Pressure Support Ventilation: A Prospective Physiological Study
The goal of this study is to validate computed inspiratory muscle pressure (cPmus) for monitoring inspiratory effort in adults receiving pressure support ventilation. Researchers will compare cPmus with reference inspiratory muscle pressure calculated using an esophageal balloon catheter, a thin pressure-measuring tube placed in the esophagus. The study will look at how closely the two methods are related and whether they give similar results. Participants will undergo simultaneous monitoring with cPmus and an esophageal balloon catheter. Researchers will adjust pressure support across six levels, recording measurements from both methods at each level.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
This is a prospective validation study with repeated measurements. It aims to validate computed inspiratory muscle pressure (cPmus), a noninvasive estimate of inspiratory muscle pressure provided by the study ventilator (Prunus Padus 9, Shenzhen, China). The reference method is esophageal pressure-derived inspiratory muscle pressure (Pmus). The study will enroll adults receiving invasive pressure support ventilation (PSV).
After obtaining informed consent, participants will undergo simultaneous monitoring with the cPmus algorithm and an esophageal balloon catheter. Pressure support will be adjusted in six levels. Positive end-expiratory pressure (PEEP) will remain unchanged. Each pressure support level will be maintained for 10 minutes. Brief end-expiratory and end-inspiratory occlusion maneuvers will also be performed at each level to obtain additional indices of respiratory drive and inspiratory effort. Esophageal balloon will be removed after completing the last pressure support step.
At each pressure support level, paired values of cPmus and reference Pmus were measured. The corresponding inspiratory pressure-time products, cPTPmus and PTPmus, will also be calculated.
All procedures will follow the study protocol and standardized measurement procedures. Study data will be recorded in case report forms and an electronic database, with checks for completeness, accuracy, and waveform quality.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jian-Xin Zhou, MD, PhD
- Número de teléfono: 8610 6392 6666
- Correo electrónico: zhoujx.cn@icloud.com
Copia de seguridad de contactos de estudio
- Nombre: Meng-Xue Hou, MD
- Correo electrónico: himengxue@163.com
Ubicaciones de estudio
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Beijing, Porcelana
- Reclutamiento
- Beijing Shijitan Hospital
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Contacto:
- Jian-Xin Zhou, MD, PhD
- Número de teléfono: 8610 6392 6666
- Correo electrónico: zhoujx.cn@icloud.com
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Contacto:
- Meng-Xue Hou, MD
- Correo electrónico: himengxue@163.com
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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:
- Age 18 years or older.
- Receiving pressure support ventilation.
- Written informed consent provided by the participant or a legally authorized representative.
Exclusion Criteria:
- Contraindication to esophageal catheter placement, including uncontrolled coagulopathy, skull base fracture, upper gastrointestinal bleeding, tumor or surgery, neck surgery, or esophagogastric varices.
- Chest trauma, a postoperative state following lung surgery, an active pulmonary air leak (pneumothorax, pneumomediastinum, or bronchopleural fistula), or an indwelling chest drain.
- Neuromuscular disease, diaphragmatic dysfunction, or diaphragmatic surgery.
- Impaired central respiratory drive due to intracranial hypertension or brainstem injury.
- Hemodynamic instability, defined as mean arterial pressure <60 mmHg, systolic blood pressure >180 mmHg, heart rate <40 or >150 beats/min, or norepinephrine dose >1 mcg/kg/min.
- Pregnancy or breastfeeding.
- A decision to withdraw life-sustaining treatment or provide palliative care.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Pressure support 15
Pressure support of 15 cm H2O will be applied for 10 minutes. |
Pressure support of 15 cm H2O will be applied for 10 minutes. |
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Experimental: Pressure support 13
Pressure support of 13 cm H2O will be applied for 10 minutes. |
Pressure support of 13 cm H2O will be applied for 10 minutes. |
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Experimental: Pressure support 11
Pressure support of 11 cm H2O will be applied for 10 minutes. |
Pressure support of 11 cm H2O will be applied for 10 minutes. |
|
Experimental: Pressure support 9
Pressure support of 9 cm H2O will be applied for 10 minutes. |
Pressure support of 9 cm H2O will be applied for 10 minutes. |
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Experimental: Pressure support 7
Pressure support of 7 cm H2O will be applied for 10 minutes. |
Pressure support of 7 cm H2O will be applied for 10 minutes. |
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Experimental: Pressure support 5
Pressure support of 5 cm H2O will be applied for 10 minutes. |
Pressure support of 5 cm H2O will be applied for 10 minutes. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Computed inspiratory muscle pressure (cPmus)
Periodo de tiempo: 2 hours
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Computed inspiratory muscle pressure (cPmus) will be measured. |
2 hours
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Inspiratory muscle pressure (Pmus)
Periodo de tiempo: 2 hours
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Inspiratory muscle pressure (Pmus) will be measured. |
2 hours
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Computed inspiratory muscle pressure-time product (cPTPmus)
Periodo de tiempo: 2 hours
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Computed inspiratory muscle pressure-time product (cPTPmus) will be measured. |
2 hours
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Inspiratory muscle pressure-time product (PTPmus)
Periodo de tiempo: 2 hours
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Inspiratory muscle pressure-time product (PTPmus) will be measured. |
2 hours
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Occluded airway pressure at 100ms (P0.1)
Periodo de tiempo: 2 hours
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Occluded airway pressure at 100ms (P0.1) will be measured. |
2 hours
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Maximal decrease of airway pressure during end-expiratory occlusion (∆Pocc)
Periodo de tiempo: 2 hours
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Maximal decrease of airway pressure during end-expiratory occlusion (∆Pocc) will be measured. |
2 hours
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Pressure muscle index (PMI)
Periodo de tiempo: 2 hours
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Pressure muscle index (PMI) will be measured. |
2 hours
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jian-Xin Zhou, Capital Medical University
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
Palabras clave
Otros números de identificación del estudio
- IIT2026-032-002
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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