Maniobra de desafío de volumen tidal y reclutamiento pulmonar (TIDALREC): la confiabilidad de la variación de la presión del pulso o la variación del volumen sistólico en la capacidad de respuesta del fluido. (TIDALEC)
Optimización Hemodinámica Intraoperatoria: Valor Predictivo de la Respuesta de Líquidos del Desafío de Volumen Tidal y la Maniobra de Reclutamiento Pulmonar mediante el Monitoreo de la Variación de la Presión Pulsada y la Variación del Volumen de Eyección Sistólica.
In order to predict fluid responsiveness in the operating room and therefore benefit of performing fluid administration to improve patient's hemodynamic status, it will test two ventilation strategies : the Tidal Volume Challenge (VtC) and the Lung Recruitment Maneuver (LRM).
The objective is to determine whether the variation of 2 parameters such as pulse pression variation (PPV) and stroke volume variation (SVV) during these 2 strategies, allows to predict fluid responsiveness in the operating room for any heavy surgery. All patients will benefit from the 2 ventilation strategies then a fluid administration, called " fluid challenge ", will be performed to discriminate the true responders and others. The order of the ventilation strategies will be determined by randomization.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Lille, Francia, 59037
- Hop Claude Huriez Chu Lille
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Patients scheduled for major abdominal, vascular or neurosurgery requiring invasive arterial monitoring of SVV and PPV with placement of a radial arterial catheter connected to the ProAQT® System.
- Block duration > 2 hours.
Exclusion Criteria:
- open thoracique surgery
- history of supra ventricular arrhythmias
- beta-blocking patient
- BMI>30 kg.m-2 or <15 kg.min-2
- right ventricular dysfunction
- severe valvulopathies
- intracardiac shunt
- renal failure dialysis
- patient's refusal
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Poner en pantalla
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Group 1
Starting LRM (Lung Recruitment Maneuver) |
The LRM is performed first for 30 seconds (an insufflation pressure of 30 cmH2O for 30 seconds is applied). After a free interval of 3 minutes, the VtC is done during 1 minute. For VtC, tidal volume is increased from 6 to 8 ml.kg-1 of predicted body weight. Finally, after a new free interval of 3 minutes, the fluid challenge (consisting in fluid administration of 250 ml of Ringer Lactate) is started for 10 minutes (in aim to determine which patients are responders). This sequence is repeated every 30 minutes (maximum four times). |
|
Experimental: Group 2
Starting VtC (Tidal Volume Challenge) |
The VtC is performed first for 1 minute. After a free interval of 3 minutes, the LRM is done for 30 seconds. Finally, after another free interval of 3 minutes, the fluid challenge is started for 10 minutes. This sequence is repe-tead every 30 minutes (maximum four times). |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
El área bajo la curva ROC (AUC) de la variación de la presión pulsada (VPP) durante la prueba de volumen corriente (VtC).
Periodo de tiempo: durante la cirugía (duración media esperada entre 3 y 5 horas). Mediciones realizadas durante secuencias de 30 minutos que pueden ocurrir varias veces durante la cirugía
|
durante la cirugía (duración media esperada entre 3 y 5 horas). Mediciones realizadas durante secuencias de 30 minutos que pueden ocurrir varias veces durante la cirugía
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The area under the ROC (AUC) curve of VPP during the alveolar recruit-ment maneuver.
Periodo de tiempo: throughout surgery (mean length expected between 3 and 5 hours). Measurements performed during sequences of 30 minutes that can occur several times during surgery
|
The AUCs are measured before and after each strategies. Afterwards, the measurement is done before and after the " fluid challenge " in each group. This sequence of measurements will be recorded every 30 minute |
throughout surgery (mean length expected between 3 and 5 hours). Measurements performed during sequences of 30 minutes that can occur several times during surgery
|
|
The AUCs of the two techniques calculated above.
Periodo de tiempo: throughout surgery (mean length expected between 3 and 5 hours). Measurements performed during sequences of 30 minutes that can occur several times during surgery
|
The AUCs are measured before and after each strategies. Afterwards, the measurement is done before and after the " fluid challenge " in each group. This sequence of measurements will be recorded every 30 minute |
throughout surgery (mean length expected between 3 and 5 hours). Measurements performed during sequences of 30 minutes that can occur several times during surgery
|
|
The area under the ROC curve (AUC) of stroke volume variation (SVV) during the tidal volume challenge (VtC).
Periodo de tiempo: throughout surgery (mean length expected between 3 and 5 hours). Measurements performed during sequences of 30 minutes that can occur several times during surgery
|
The AUCs are measured before and after each strategies. Afterwards, the measurement is done before and after the " fluid challenge " in each group. This sequence of measurements will be recorded every 30 minute |
throughout surgery (mean length expected between 3 and 5 hours). Measurements performed during sequences of 30 minutes that can occur several times during surgery
|
|
The area under the ROC curve (AUC) of stroke volume variation (SVV) during the lung recruitment maneuver.
Periodo de tiempo: throughout surgery (mean length expected between 3 and 5 hours). Measurements performed during sequences of 30 minutes that can occur several times during surgery
|
The AUCs are measured before and after each strategies. Afterwards, the measurement is done before and after the " fluid challenge " in each group. This sequence of measurements will be recorded every 30 minute |
throughout surgery (mean length expected between 3 and 5 hours). Measurements performed during sequences of 30 minutes that can occur several times during surgery
|
|
Number of complications in pneumothorax
Periodo de tiempo: 1 day (at recovery room after surgery) and at day 2
|
Pneumothorax is detected on chest x-ray in recovery room and then on clinical examination at Day 2. |
1 day (at recovery room after surgery) and at day 2
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Gilles Lebuffe, MD,PhD, University Hospital, Lille
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
- 2019_71
- 2020-A01460-39 (Otro identificador: ID-RCB number,ANSM)
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.
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. .