Ignite Creation Date:
2024-05-06 @ 9:19 AM
Last Modification Date:
2024-10-26 @ 12:12 PM
Study NCT ID:
NCT02954861
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2016-09-08
Brief Title:
A Study to Identify the Incidence of Post Traumatic Stress Symptoms in Patients With Delirium Following Cardiac Surgery
Sponsor:
University of Edinburgh
Organization:
University of Edinburgh
Study Overview
Official Title:
A Study to Identify the Incidence of Post Traumatic Stress Symptoms in Patients With Delirium Following Cardiac Surgery
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
Active not recruiting
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 courseThough 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 ie 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
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 ie 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
Detailed Description:
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 patients 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 participants 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
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 patients 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 participants 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None