A Study to Identify the Incidence of Post Traumatic Stress Symptoms in Patients With Delirium Following Cardiac Surgery
'Post perfusion syndrome' was a term historically associated to cardiac surgery in view of the transient neuro-cognitive deficits attributed to cardio pulmonary bypass pump. During their recovery period, a significant number of patients experience delirium, a clinical syndrome of acute onset and fluctuant course.Though these deficits are often known to be transient without any permanent physical or neurological impairment, the experience can still psycho-socially affect these patients for a longer length of time even after discharge. The presence of delirium puts excessive, undesired strain on the patient, their families, health care providers and hospital resources.
PTSS is an anxiety disorder caused by very stressful, frightening or distressing events. It is known to either develop immediately after the disturbing event or weeks and months later. The actual symptoms can be varied but are categorized in three sections: i.e.: re-experiencing, avoidance and emotional numbing and hyperarousal (feeling 'on edge').
A problem that has such an impact on any patient is worth investigating and understood better. Being in such a unique professional position, as a Clinical nurse practitioner, the investigator is ideally placed to conduct this study. In this study, the researcher will be focusing on the pre-operative risk factors in developing delirium, actual incidence of delirium and follow the patients post operatively to evaluate the after effects of delirium in the form of PTSS.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Delirium is acute onset of fluctuant cognitive state. Post operative delirium is a historically known complication after cardiac surgery. In 2013, almost 900 heart operations were performed in a South East, Scottish Cardio Thoracic unit. and audit data shows that 45% of these patients developed post operative delirium.
Multiple pre, post & intra operative factors have been attributed to the development of delirium. Whatever the precipitating factors, delirium not only causes psychological distress to the patient but also their loved ones. In some cases this psychological upset continues to affect the patient even after discharge from the hospital referred to as post traumatic stress symptoms (PTSS). This study therefore aims to look at the extent and experience of post operative delirium in cardiac surgery patients.
The study plans to recruit patients at a pre admission clinic where patient's baseline clinical data will be collected. They will also be provided with questionnaires to complete before the end of the clinic. This is to evaluate the participant's pre operative mood, cognitive status and social orientation. During their hospital stay following surgery the participants will be assessed routinely for delirium. If they are known to have suffered from delirium, they will be enrolled to phase 2 of the study.
The consented patients will be seen at 6 week follow up clinic where they will be provided with a questionnaire to identify PTSS and also participate in a semi structured interview. Three months later the same will be repeated on telephone.
Data analysis will help understand and explore this unfortunate patient experience.
Tipo de estudio
Inscripción (Anticipado)
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Following discussion with statisticians and viewing the sample sizes of previous related studies, it was suggested that minimum 200 patients will be required for phase I. This was based on the availability of data in a similar aspects of the study. But incidentally there has been no known study looking specifically at delirium and post traumatic stress symptoms in cardiac surgery patients. So the researcher aims to enrol at least 400 patients but may not be able to achieve this number by the end of data collection phase.
Phase II will only have patients who develop delirium and convenient sampling will be applied for the interview section.
Descripción
The target population will be all consecutive patients being operated during the data collection period.
Inclusion criteria:
- Male or female participants age 18 and over.
- Adults with capacity to informed consent
- Elective and urgent conventional cardiac surgery.
Exclusion Criteria:
- Patients from the highlands and islands who may not wish to return to the 6 weeks follow up clinic
- Re-do Cardiac surgery
- Emergency Cardiac surgery.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Cardiac surgery
Patients who develop delirium following cardiac surgery
|
Sin intervención
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
What factors during the peri-operative period in patients with delirium are associated with higher incidence of post traumatic stress symptoms?
Periodo de tiempo: 6 weeks and 3 months following delirium post cardiac surgery
|
6 weeks and 3 months following delirium post cardiac surgery
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
What are the peri-operative factors that are associated with change in PTSS score from 6 weeks to 3 months.
Periodo de tiempo: 6-12 weeks
|
6-12 weeks
|
|
|
What are the pre operative features that predict post operative delirium
Periodo de tiempo: 5 days
|
The pre operative data collected will form an entry baseline for the study.
But this will also aid in identifying common factors that are noted in patients who develop post operative delirium.
|
5 days
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Desordenes mentales
- Enfermedades cardiovasculares
- Enfermedades del Sistema Nervioso
- Manifestaciones neurológicas
- Confusión
- Manifestaciones neuroconductuales
- Trastornos neurocognitivos
- Trastornos relacionados con el trauma y el estrés
- Trastornos de Estrés, Traumáticos
- Enfermedades cardíacas
- Delirio
- Trastornos de estrés postraumático
Otros números de identificación del estudio
- 172976
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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. .
Ensayos clínicos sobre Delirio
-
Jubilee Mission Medical College and Research InstituteINCRE fellowship from DBT, govt of IndiaTerminadoSíntomas de abstinencia de alcohol | Delirium Tremens (DT)
-
Denver Health and Hospital AuthorityTerminadoDelirio por abstinencia de alcohol | Hiperactividad autonómica asociada a la abstinencia de alcohol | Alucinosis por abstinencia de alcohol | Delirium Tremens inducido por abstinencia de alcoholEstados Unidos
Ensayos clínicos sobre Sin intervención
-
University of OxfordOxford University Hospitals NHS TrustDesconocidoSíntomas de comportamientoReino Unido
-
Shiraz University of Medical SciencesTerminado
-
Heidelberg UniversityDesconocidoRetraso de idioma | Trastornos del desarrollo del lenguajeAlemania
-
Munich Municipal HospitalTechnical University of Munich; University of RegensburgDesconocido
-
Ottawa Heart Institute Research CorporationCanadian Institutes of Health Research (CIHR)Activo, no reclutandoDependencia a la nicotina, cigarrillos | Abstinencia de nicotinaCanadá
-
IWK Health CentreCanadian Institutes of Health Research (CIHR)TerminadoTrastorno de oposición desafiante | Trastorno de conductaCanadá
-
The Hospital for Sick ChildrenTerminadoObesidad infantilCanadá
-
VA Office of Research and DevelopmentTerminadoTrastornos de Estrés PostraumáticoEstados Unidos
-
IWK Health CentreMcGill University; Canadian Institutes of Health Research (CIHR); University of... y otros colaboradoresActivo, no reclutandoTrastornos del neurodesarrollo | Trastornos del ComportamientoCanadá
-
Sahlgrenska University Hospital, SwedenKarolinska University Hospital; Skane University Hospital; Karlstad Central Hospital y otros colaboradoresActivo, no reclutandoClaudicación intermitenteSuecia