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- Ensayo clínico NCT02020863
Closed-Loop Fluid Administration System Using Hemodynamic Monitors
20 de abril de 2016 actualizado por: Maxime Cannesson, University of California, Irvine
The purpose of this study is to evaluate the feasibility of a closed-loop (automated) fluid administration system to deliver fluids using feedback from standard operating room hemodynamic monitors.
In standard anesthesia care the rate of IV fluid administration to the patient is determined by the anesthesiologist caring for the patient.
In this study protocol, the rate of fluid administration will be determined instead by the closed-loop (automated) control system under the supervision of the anesthesiologist.
The system will independently decide when to give fluid and at what rate; the supervising anesthesiologist will monitor the system to ensure appropriate volumes are being delivered and to intervene if necessary.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
In our protocol we will test the hypothesis that closed-loop fluid administration can maintain higher cardiac stroke volume (shown to improve patient outcomes after surgery) than anesthesiologist management.
We have shown this to be the case in multiple simulation studies and in-vivo animal studies, but not yet experimentally in a clinical setting.
Investigators will recruit their patients from the surgical record that that require cardiac output monitoring undergoing surgery and require mechanical ventilation and consent to participate in the study will be included in the study.
They will receive standard patient care in that in no way will their anesthetic or surgical procedure will be altered as part of the study, with the exception of fluid administration.
Fluids are usually given to a patient based on the physician's discretion.
As part of the study patients will receive fluid management via a closed loop (automated) system that will use an infusion pump (Q-Core) and a controller (a computer run index and algorithm developed by Sironis) to make frequent, regular and accurate adjustments to the amount of fluid the patient receives using feedback from standard operating room monitors at UCI).
Data from this study will be retrospectively compared to subjects case matched to evaluate differences in cardiac output, total fluid given, and patient outcomes.
Tipo de estudio
Intervencionista
Inscripción (Actual)
40
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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California
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Orange, California, Estados Unidos, 92858
- University of California, Irvine Medical Center
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Adult subjects (over the age of 18)
- Subjects undergoing elective major, abdominal surgery
- Subjects requiring general anesthesia and mechanical ventilation
- Subjects requiring cardiac output monitoring and an arterial line
Exclusion Criteria:
- Subjects under 18 years of age
- Subjects not undergoing surgery
- Subjects not requiring general anesthesia or mechanical ventilation
- Subjects not requiring cardiac output monitoring or an arterial line
- Subjects who are pregnant
- Subjects without the capacity to give informed consent
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Closed Loop
Study patients will receive a baseline crystalloid infusion of 3 cc/kg/hr and all additional fluid management will be performed via a closed loop (automated) system that will determine rate, amount, and timing of fluid administration.
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Fluid management in the closed loop group will be performed via a closed loop (automated) system that will use an infusion pump (Q-Core) and a controller (a computer run index and algorithm developed by Sironis) to make frequent, regular and accurate adjustments to the amount of fluid the patient receives using feedback from standard operating room monitors.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Fluid Status During Surgery
Periodo de tiempo: Duration of Surgery, up to 8 hours
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The primary outcome between groups is preload independence, defined as % case time where Stroke Volume Variation (SVV) is ≤12%.
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Duration of Surgery, up to 8 hours
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Maxime Cannesson, MD, PhD, University of California, Irvine
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Pearse R, Dawson D, Fawcett J, Rhodes A, Grounds RM, Bennett ED. Early goal-directed therapy after major surgery reduces complications and duration of hospital stay. A randomised, controlled trial [ISRCTN38797445]. Crit Care. 2005;9(6):R687-93. doi: 10.1186/cc3887. Epub 2005 Nov 8.
- Rinehart J, Liu N, Alexander B, Cannesson M. Review article: closed-loop systems in anesthesia: is there a potential for closed-loop fluid management and hemodynamic optimization? Anesth Analg. 2012 Jan;114(1):130-43. doi: 10.1213/ANE.0b013e318230e9e0. Epub 2011 Sep 29.
- Bednarski P, Siclari F, Voigt A, Demertzis S, Lau G. Use of a computerized closed-loop sodium nitroprusside titration system for antihypertensive treatment after open heart surgery. Crit Care Med. 1990 Oct;18(10):1061-5. doi: 10.1097/00003246-199010000-00002.
- Colvin JR, Kenny GN. Development and evaluation of a dual-pump microcomputer-based closed-loop arterial pressure control system. Int J Clin Monit Comput. 1989 Jan;6(1):31-5. doi: 10.1007/BF01723370.
- Blankenship HB, Wallace FD, Pacifico AD. Clinical application of closed-loop postoperative autotransfusion. Med Prog Technol. 1990 May;16(1-2):89-93.
- Bowman RJ, Westenskow DR. A microcomputer-based fluid infusion system for the resuscitation of burn patients. IEEE Trans Biomed Eng. 1981 Jun;28(6):475-9. doi: 10.1109/TBME.1981.324822. No abstract available.
- Chaisson NF, Kirschner RA, Deyo DJ, Lopez JA, Prough DS, Kramer GC. Near-infrared spectroscopy-guided closed-loop resuscitation of hemorrhage. J Trauma. 2003 May;54(5 Suppl):S183-92. doi: 10.1097/01.TA.0000064508.11512.28.
- DeBey RK, Westenskow DR, Jordan WS, McJames SW. A urine based control system for fluid infusion. Biomed Sci Instrum. 1987;23:195-8. No abstract available.
- Rinehart J, Alexander B, Le Manach Y, Hofer C, Tavernier B, Kain ZN, Cannesson M. Evaluation of a novel closed-loop fluid-administration system based on dynamic predictors of fluid responsiveness: an in silico simulation study. Crit Care. 2011;15(6):R278. doi: 10.1186/cc10562. Epub 2011 Nov 23.
- Rinehart J, Lee C, Cannesson M, Dumont G. Closed-loop fluid resuscitation: robustness against weight and cardiac contractility variations. Anesth Analg. 2013 Nov;117(5):1110-8. doi: 10.1213/ANE.0b013e3182930050.
- Rinehart J, Lee C, Canales C, Kong A, Kain Z, Cannesson M. Closed-loop fluid administration compared to anesthesiologist management for hemodynamic optimization and resuscitation during surgery: an in vivo study. Anesth Analg. 2013 Nov;117(5):1119-29. doi: 10.1213/ANE.0b013e3182937d61.
- Forget P, Lois F, de Kock M. Goal-directed fluid management based on the pulse oximeter-derived pleth variability index reduces lactate levels and improves fluid management. Anesth Analg. 2010 Oct;111(4):910-4. doi: 10.1213/ANE.0b013e3181eb624f. Epub 2010 Aug 12.
- Rinehart J, Chung E, Canales C, Cannesson M. Intraoperative stroke volume optimization using stroke volume, arterial pressure, and heart rate: closed-loop (learning intravenous resuscitator) versus anesthesiologists. J Cardiothorac Vasc Anesth. 2012 Oct;26(5):933-9. doi: 10.1053/j.jvca.2012.05.015. Epub 2012 Jul 12.
- Rinehart J, Lilot M, Lee C, Joosten A, Huynh T, Canales C, Imagawa D, Demirjian A, Cannesson M. Closed-loop assisted versus manual goal-directed fluid therapy during high-risk abdominal surgery: a case-control study with propensity matching. Crit Care. 2015 Mar 19;19(1):94. doi: 10.1186/s13054-015-0827-7.
- Joosten A, Huynh T, Suehiro K, Canales C, Cannesson M, Rinehart J. Goal-Directed fluid therapy with closed-loop assistance during moderate risk surgery using noninvasive cardiac output monitoring: A pilot study. Br J Anaesth. 2015 Jun;114(6):886-92. doi: 10.1093/bja/aev002. Epub 2015 Feb 17.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de noviembre de 2012
Finalización primaria (Actual)
1 de mayo de 2014
Finalización del estudio (Actual)
1 de mayo de 2014
Fechas de registro del estudio
Enviado por primera vez
19 de diciembre de 2013
Primero enviado que cumplió con los criterios de control de calidad
19 de diciembre de 2013
Publicado por primera vez (Estimar)
25 de diciembre de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
27 de mayo de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
20 de abril de 2016
Última verificación
1 de abril de 2016
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- UCIANES03
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Indeciso
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. .
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