Time-controlled Adaptive Ventilation (TCAV) Compared With Conventional Ventilation in Patients With Moderate-to-severe Acute Respiratory Distress Syndrome (ARDS) Secondary to Community-acquired Pneumonia (EARLY-TCAV)
Efficacy and Safety of Time-controlled Adaptive Ventilation (TCAV) Compared With Conventional Ventilation in Patients Requiring Invasive Ventilation for Moderate-to-severe Acute Respiratory Distress Syndrome (ARDS) Secondary to Community-acquired Pneumonia
ARDS is a pathology with mortality rates reaching 40%. Invasive ventilation, the cornerstone of ARDS management, leads to "ventilation-induced lung injury" (VILI). An approach based on pressure-controlled ventilation with unassisted spontaneous respirations (PC-SV or APRV) can limit the occurrence of VILI. Time-controlled adaptive ventilation (TCAV) is based on high mean inspiratory airway pressure, while limiting expiratory time at low pressure. TCAV has shown positive effects in experimental and observational studies. However, its efficacy and safety in patients with moderate-to-severe ARDS remains to be evaluated.
Evaluation of the efficacy of early application of TCAV compared to standard ventilation on the severity of alveolar damage leading to injury-related pulmonary edema in patients with moderate to severe ARDS After obtaining patient's consent, eligible patients will be included in this open-label, randomized controlled pilot study with stratification by minimization based on initial severity. The experimental group will be the TCAV group, where ventilator settings will be standardized. The ventilator in the standard care group will be set to volumetric mode with positive end-expiratory pressure according to the EXPRESS protocol.
The measurement of extravascular lung water will be compared on day 2 between the TCAV settings group and the standard care settings group using the PICCO system.
The TCAV setting is simple and inexpensive. In ARDS patients, the increase in injury-related pulmonary edema is a relevant marker of mortality, and its reduction could improve patients' outcomes. Our study aims to evaluate the efficacy and safety of these settings to justify a future large-scale, multicenter randomized trial.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Matthieu KOSZUTSKI, MD
- Número de teléfono: +33 3 83 15 30 17
- Correo electrónico: m.koszutski@chru-nancy.fr
Ubicaciones de estudio
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Nancy, Francia, 54000
- CHRU de Nancy
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Contacto:
- Matthieu KOSZUTSKI, MD
- Número de teléfono: +33 3 3 83 15 30 17
- Correo electrónico: m.koszutski@chru-nancy.fr
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Intensive care unit hospitalisation for ARDS with a PaO₂/FiO₂ ratio ≤ 200 mmHg and PEEP ≥ 5 cmH₂O under invasive ventilation
- Criteria for community-acquired pneumonia, 2 of the following: cough, purulent sputum, chest pain, dyspnea
- Onset of symptoms ≤ 7 days
- Invasive ventilation initiated ≤ 24 hours
- Affiliation to a social security program
- Patient for whom written consent has been obtained from a trusted person or a family member, or inclusion in a situation of immediate life-threatening emergency
Exclusion Criteria:
- Focal ARDS defined as unilateral involvement (1 out of 4 quadrants or 2 on the same side) on imaging (chest X-ray or CT scan)
- Right heart failure not related to acute pulmonary heart disease secondary to ARDS (pulmonary embolism, myocarditis, ischemic cause)
- Pneumothorax, drained or undrained, with a persistent pleural air leak
- COPD with significant obstructive impairment defined by the presence of chronic respiratory disease and oxygen therapy or non-invasive ventilation at home
- Circulatory support via VV-ECMO or VA-ECMO
- Presence of a patent foramen ovale
- Active limitation of therapies
- Increased intracranial pressure
- Sickle cell disease
- Burns > 30%
- Expected invasive mechanical ventilation for less than 48 hours
- A person covered by Articles L. 1121-5, L. 1121-7, and L. 1121-8 of the French Public Health Code
- Pregnant or breastfeeding women
- A not emancipated minor
- Adults subject to legal protective measures (guardianship, conservatorship, judicial protection) or inability to give consent
- Persons deprived of liberty by a judicial or administrative decision, persons receiving psychiatric care pursuant to Articles L. 3212-1 and L. 3213-1
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Time-controlled Adaptative Ventilation
Invasive ventilation with the ventilator set on the Airway Pressure Release Ventilation mode.
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Invasive ventilation with the ventilator set on the Airway Pressure Release Ventilation mode as follows:
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Comparador activo: Volume Control
Invasive ventilation with the ventilator set on the Volume control mode.
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Invasive ventilation with the ventilator set on the Volume control mode as follows:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Extravascular Lung Water (EVLW)
Periodo de tiempo: 48 hours
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Measured with transpulmonary thermodilution (TPTD) and expressed in ml per kilogram of body weight
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48 hours
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Mortality
Periodo de tiempo: 60 days
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Occurrence of death
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60 days
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Ventilator-free days
Periodo de tiempo: day 30
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Number of days without invasive or non-invasive ventilation
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day 30
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Major Adverse Kidney Events (MAKE)
Periodo de tiempo: Day 7, Day 30
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Need of dialysis, decrease ≥ 25% of glomerular filtration rate and all cause-death
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Day 7, Day 30
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Adverse Events
Periodo de tiempo: Day 30
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Defined as:
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Day 30
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Pressure difference
Periodo de tiempo: day 1, day 2, day 3, day 4
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in cmH20
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day 1, day 2, day 3, day 4
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Extravascular Lung Water Indexed to the predicted body weight (EVLWIp)
Periodo de tiempo: 48 hours
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Measured with transpulmonary thermodilution (TPTD) and expressed in ml per kilogram of predicted body weight
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48 hours
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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
- 2024PI147
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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