TP-EchoMonitoring the Brain in On-pump Cardiovascular Surgery: The Role of Transpharyngeal Ultrasonography as a Non-invasive Adjunct to Assess Cerebral Perfusion
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Recopilados en un punto de tiempo - TransversalSolo Casos
Examinando las características de las personas con una enfermedad para identificar factores genéticos o ambientales que contribuyen a la condición.Resumen
Fecha de inicio: 1 de abril de 2013
Fecha en la que se inscribió al primer participante.Background Cerebral hypo- or malperfusion during cardiovascular surgery can lead to grave consequences including transient cerebral ischemia or stroke impairing patient's daily life and affect surgical outcome. For this reason a multimodal neuromonitoring strategy using a variety of devices (evoked potentials, near-infrared spectroscopy, transcranial Doppler ultrasonography) with different technologies has been recommended by medical societies. These techniques have various limitations and cannot be used in all clinical situations. In contrast, transpharyngeal ultrasonography (TPU) represents a simple and readily available technique: the transesophageal echocardiography probe, routinely placed in most cardiac surgical patients for monitoring and assessment of surgical results, will be withdrawn into the upper esophagus making the visualization of supraaortic branches possible. To date, there are several reports about imaging of aortic arch branches using TPU. The utility of this technique, however, for systematic cerebrovascular monitoring has not have been investigated so far. Objective The aim of this study is to investigate TPU as a cerebrovascular monitoring adjunct in two cohorts of on-pump cardiac surgery procedures. Clinical feasibility and diagnostic accuracy of antegrade carotid flow detection are compared to the established reference methods of Duplex sonography and transcranial Doppler ultrasound. Methods All patients receive anesthetic and surgical management according to institutional standards. Patient enrollment in the study occurs consecutively and unblinded for surgical procedure. All patients receive TPU, Duplex sonography and transcranial Doppler examination after anesthesia induction preoperatively, during extracorporeal circulation and after weaning from cardiopulmonary bypass. In addition, the patients in cohort 2.(ascending aortic repair with DHCA) receive above mentioned noninvasive ultrasound / Doppler measurements also during the period of DHCA with and without antegrade cerebral perfusion. Image acquisition and data extraction are conducted by different persons to avoid investigator-related bias.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 32 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Solo Casos
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Criterios
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Objetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
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Dep. of Anesthesiology and Pain therapy
Bern, SwitzerlandAbrir Dep. of Anesthesiology and Pain therapy en Google Maps