A Study to Identify the Incidence of Post Traumatic Stress Symptoms in Patients With Delirium Following Cardiac Surgery

NCT02954861 | Completed

• 1 other identifier: 172976
• Study Type: observational
• Target: 406
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Cardiac Disease; Delirium; Stress Disorders, Post-Traumatic

Outcome Measures

Primary Outcomes (1)

• What factors during the peri-operative period in patients with delirium are associated with higher incidence of post traumatic stress symptoms?

  6 weeks and 3 months following delirium post cardiac surgery

Secondary Outcomes (2)

• What are the peri-operative factors that are associated with change in PTSS score from 6 weeks to 3 months.

  6-12 weeks

• What are the pre operative features that predict post operative delirium

  5 days

Study Arms (1)

Cardiac surgery

Patients who develop delirium following cardiac surgery

Other: No intervention

Interventions

No intervention OTHER

No intervention

Cardiac surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• Male or female participants age 18 and over.
• Adults with capacity to informed consent
• Elective and urgent conventional cardiac surgery.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Lothian: collaborator

MeSH Terms

Conditions

Heart Diseases; Delirium; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2016
• First Posted: November 4, 2016
• Study Start: April 7, 2016
• Primary Completion: March 30, 2018
• Study Completion: May 10, 2018
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share