Cardiovascular Diseases Clinical Trial
— VINCIOfficial title:
Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
Patients are part of a family network. When any person in a family becomes critically unwell
and requires the assistance of an Intensive Care Unit (ICU), this has an impact on all
members of that family.
COVID-19 changed visiting for all patients in hospitals across Scotland. It is not known what
effect these restrictions will have on patients' recovery, nor do we understand the impact it
may have on their relatives or staff caring for them. This study will look at the
implications of the visiting restrictions as a consequence of the COVID-19 pandemic upon
patients without COVID-19 who are in the cardiothoracic ICU. It will also explore the impact
of these restrictions on them, their relatives and staff.
This study will be carried out within a single specialised intensive care unit in Scotland
using mixed methods.
The first arm of this study will use retrospective data that is routinely collected in normal
clinical practice. The investigators will compare patient outcomes prior to COVID-19 with
outcomes following the implementation of COVID-19 visiting restrictions. The aim is to
establish if the restrictions on visiting has an impact on the duration of delirium. Delirium
is an acute mental confusion and is associated with longer hospital stays and worse outcomes
in this patient group.
The second arm of this study involves semi-structured interviews with patients, relatives and
staff that will allow deeper exploration of the issues around current visiting policy. The
interviews will last approximately 1 hour and will address these issues. They will then be
transcribed word for word and analysed using grounded theory, meaning the theories will
develop from the data as it is analysed.
Status | Not yet recruiting |
Enrollment | 1000 |
Est. completion date | December 2021 |
Est. primary completion date | December 2021 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
Arm 1 Inclusion Criteria: - Length of stay within critical care > 4 days - Age > 18 years - Patients who have been admitted: - Following cardiac or thoracic surgery or, - For treatment of advanced heart failure Exclusion Criteria: - Pregnancy - Diagnosed learning disability - Pre-admission evidence of cognitive impairment - Patients admitted to the ICU following ear nose and throat (ENT) procedures - Patients admitted to the ICU following orthopaedics procedure - Patients admitted to the ICU following general surgical procedures - Patients admitted following out of hospital cardiac arrest - Patients admitted for COVID-19 pneumonia Arm 2 Inclusion Criteria: For Patients: - Length of stay within critical care > 4 days - Age > 18 years - Reason for admission - Post-operative patients following cardiac or thoracic surgery or, - Following admission for advanced heart failure therapies - Provision of informed consent For relatives: - Age > 18 years - Relative of a patient that has been in critical care > 4 days - Relative of a patient who has been admitted: - Following cardiac or thoracic surgery or, - Treatment of advanced heart failure - Relative of a patient admitted for > 4days For Staff: - Age > 18 - Clinical responsibility within the critical care department Exclusion: For patients: - Prisoners - Age < 18yrs - No family or social support - Non-English speaker - Pre-admission evidence of cognitive impairment - Pre-admission diagnosis of learning disability - Imminent death - Brain injury - Lacks capacity (using Montreal Cognitive Assessment tool (MoCA)) - Patients admitted after out of hospital cardiac arrest - Patients admitted to the ICU following ENT procedures - Patients admitted to the ICU following orthopaedics procedure - Patients admitted to the ICU following general surgical procedures - Patients admitted with COVID-19 pneumonia For relatives: - Prisoner - Age < 18yrs - Non-English speaker - Relative of a patient who is close to death - Relative of a patient admitted after out of hospital cardiac arrest - Relative of a patient admitted for ENT procedure - Relative of a patient admitted for orthopaedic procedure - Relative of a patient admitted following general surgical procedure For Staff: • Age < 18yrs |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Glasgow | Golden Jubilee National Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Exploring the experiences of patients, relatives and staff of the visitation restrictions during the COVID-19 pandemic | Semi structured interviews | 18 months | |
Primary | Duration of delirium | Number of days patient found to have delirium using the Confusion Assessment Method for the ICU (CAM-ICU) | From the date of admission to the Intensive Care Unit (ICU) until discharge from the ICU or death, whichever came first, up to 12 months. | |
Secondary | Incidence of delirium | CAM-ICU | From the date of admission to the Intensive Care Unit (ICU) until discharge from the ICU or death, whichever came first, up to 12 months. | |
Secondary | Length of critical care stay | Days | From the date of admission to the ICU until discharge from the ICU or death, whichever came first, up to 12 months. | |
Secondary | Length of hospital stay | Days | From the date of admission to the hospital until discharge from the hospital or death, whichever came first, up to 12 months. | |
Secondary | Doses of specified drugs during ICU admission | From the date of admission to the ICU until discharge from the ICU or death, whichever came first, up to 12 months. | ||
Secondary | Length of time ventilated | Days | From the date of admission to the ICU until discharge from the ICU or death, whichever came first, up to 12 months. | |
Secondary | Mortality | 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
Recruiting |
NCT05650307 -
CV Imaging of Metabolic Interventions
|
||
Recruiting |
NCT04515303 -
Digital Intervention Participation in DASH
|
||
Completed |
NCT04056208 -
Pistachios Blood Sugar Control, Heart and Gut Health
|
Phase 2 | |
Recruiting |
NCT04417387 -
The Genetics and Vascular Health Check Study (GENVASC) Aims to Help Determine Whether Gathering Genetic Information Can Improve the Prediction of Risk of Coronary Artery Disease (CAD)
|
||
Not yet recruiting |
NCT06211361 -
Cardiac Rehabilitation Program in Patients With Cardiovascular Disease
|
N/A | |
Not yet recruiting |
NCT06032572 -
Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE)
|
N/A | |
Recruiting |
NCT04514445 -
The BRAVE Study- The Identification of Genetic Variants Associated With Bicuspid Aortic Valve Using a Combination of Case-control and Family-based Approaches.
|
||
Enrolling by invitation |
NCT04253054 -
Chinese Multi-provincial Cohort Study-Beijing Project
|
||
Completed |
NCT03273972 -
INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers
|
N/A | |
Completed |
NCT03680638 -
The Effect of Antioxidants on Skin Blood Flow During Local Heating
|
Phase 1 | |
Recruiting |
NCT04843891 -
Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis.
|
Phase 1 | |
Completed |
NCT04083872 -
Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of Highdose CKD-385 in Healthy Volunteers(Fasting)
|
Phase 1 | |
Completed |
NCT04083846 -
Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers(Fed)
|
Phase 1 | |
Completed |
NCT03619148 -
The Incidence of Respiratory Symptoms Associated With the Use of HFNO
|
N/A | |
Completed |
NCT03693365 -
Fluid Responsiveness Tested by the Effective Pulmonary Blood Flow During a Positive End-expiratory Trial
|
||
Completed |
NCT03466333 -
Postnatal Enalapril to Improve Cardiovascular fUnction Following Preterm Pre-eclampsia
|
Phase 2 | |
Completed |
NCT04082585 -
Total Health Improvement Program Research Project
|
||
Completed |
NCT05132998 -
Impact of a Comprehensive Cardiac Rehabilitation Program Framework Among High Cardiovascular Risk Cancer Survivors
|
N/A | |
Completed |
NCT05067114 -
Solutions for Atrial Fibrillation Edvocacy (SAFE)
|