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| Name | Class |
|---|---|
| University of Glasgow | OTHER |
| NHS Greater Glasgow and Clyde | OTHER |
| Royal London Hospital | UNKNOWN |
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A study to see how common right heart failure (right ventricular dysfunction) after major surgery is, and to investigate if right ventricular dysfunction causes worse patient outcomes after surgery.
Heart attacks are relatively rare around the time of surgery, however by measuring blood markers of heart injury, recent research has revealed that heart injury which otherwise may not be immediately obvious is common. Whilst this type of heart injury appears to be strongly linked to patient outcomes (complications, recovery and survival), the causes and potential treatments for it are not well understood.
Our research group has specialist knowledge about the right-hand side of the heart (right-heart) - the side that pumps blood through the lungs - which is less commonly considered or studied around the time of surgery. We have shown in previous studies using magnetic resonance imaging (MRI) scans (specialised whole-body scans which use a magnet rather than X-rays), evidence of right-heart function deteriorating after surgery. We want to test the idea that some of the blood marker evidence of heart injury reflects injury to the right-heart and more importantly that we can protect the right-heart around the time of surgery, reducing injury and improving patient outcomes.
We will examine these questions in the following ways:
This study will give us a better understanding of which patients are likely to suffer heart injury around the time of surgery and how this injury occurs. With this knowledge, future patients could receive personalised treatment plans aimed at preventing injury and improving outcomes. We are not testing any new treatments in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thoracic surgery cohort | 35 patients undergoing thoracic surgery with lung resection and one lung ventilation under primarily general anaesthesia. |
| |
| Upper gastrointestinal surgery cohort | 35 patients undergoing upper gastrointestinal surgery with one lung ventilation under primarily general anaesthesia. |
| |
| Colorectal surgery cohort | 35 patients undergoing elective colorectal surgery under primarily general anaesthesia. |
| |
| Vascular surgery cohort | 35 patients undergoing elective open abdominal aortic surgery under primarily general anaesthesia. |
| |
| Orthopaedic surgery cohort | 35 patients undergoing elective primary hip or knee arthroplasty under spinal anaesthesia +/- sedation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Echocardiography | Diagnostic Test | Echocardiography will be performed by BSE accredited echocardiographers in all 175 patients preoperatively and on day 2-4 postoperatively. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of postoperative Right ventricular dysfunction (RVD) | RVD diagnosed by transthoracic echocardiography, defined as:
| Echocardiography performed preoperatively and at day 2-4 postoperatively to measure change in RV function |
| Days alive and at home at 30 days postoperatively (DAH30) | DAH30 is a continuous number between 0 and 30 which reflects, out of the 30 days following surgery, the total number of those days that a patient spends alive and at home. If a patient dies within those 30 days, their value is set to 0. Data for DAH30 will be obtained by follow-up phone calls following the 30th postoperative day. | Day 30 postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of postoperative left ventricular dysfunction (LVD) | LVD classified as mild, moderately or severely impaired, defined by 2D-echocardiography derived biplane LV ejection fraction and the presence of wall motion abnormalities. | Echocardiography performed preoperatively and at day 2-4 postoperatively to measure change in LV function |
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Main echocardiography study
Inclusion Criteria:
Exclusion Criteria:
Additional exclusion criteria applicable to the T1 CMR sub-study includes:
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175 patients of 18 years or older undergoing major non-cardiac surgery in the West of Scotland. Patients will be recruited from the Golden Jubilee National Hospital, Queen Elizabeth University Hospital, and Glasgow Royal Infirmary.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ben Shelley | Contact | 0141 951 5000 | Benjamin.Shelley@glasgow.ac.uk | |
| Philip McCall | Contact | 0141 951 5000 | Philip.mccall@glasgow.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Ben Shelley | National Waiting Times Centre Board | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Golden Jubilee National Hospital | Clydebank | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37673452 | Derived | Keast T, McErlane J, Kearns R, McKinlay S, Raju I, Watson M, Robertson KE, Berry C, Greenlaw N, Ackland G, McCall P, Shelley B. Study protocol for IMPRoVE: a multicentre prospective observational cohort study of the incidence, impact and mechanisms of perioperative right ventricular dysfunction in non-cardiac surgery. BMJ Open. 2023 Sep 6;13(9):e074687. doi: 10.1136/bmjopen-2023-074687. |
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| T1 Cardiovascular Magnetic Resonance | Diagnostic Test | T1 CMR will be performed in 10 patients from each of the 5 surgical groups (50 patients in total) preoperatively and on day 2-4 postoperatively. |
|
| Right heart catheterisation and coronary sinus blood sampling | Diagnostic Test | 10 patients from the thoracic surgical group will undergo right heart catheterisation and coronary sinus blood sampling. |
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| Cardiac biomarkers |
Natriuretic peptides and high sensitivity troponin will be measured pre- and postoperatively. |
| BNP and troponin measured preoperatively, on postoperative days 1 and 2 and on day of postoperative echocardiography (occurring on postoperative days 2-4). |
| Cardiovascular complications | Incidence of myocardial infarction, cardiac death, non-fatal cardiac arrest, coronary revascularisation, pulmonary embolus, deep-veined thrombosis, or new onset atrial fibrillation, and major adverse cardiac events | Day of postoperative echocardiography (day 2-4 postoperatively) and at discharge (on average one week). |
| Renal outcomes | Kidney Disease Improving Global Outcome (KDIGO) classification of Acute Kidney Injury (AKI). | Day of postoperative echocardiography (day 2-4 postoperatively) and at discharge (on average one week). |
| Pulmonary outcomes | Atelectasis, pneumonia, acute respiratory distress syndrome or pulmonary aspiration | Day of postoperative echocardiography (day 2-4 postoperatively) and at discharge (on average one week). |
| Infection Outcomes | Fever and clinical suspicion of infection | Day of postoperative echocardiography (day 2-4 postoperatively) and at discharge (on average one week). |
| Neurological outcomes | Delirium and stroke | Day of postoperative echocardiography (day 2-4 postoperatively) and at discharge (on average one week). |
| Sequential Organ Failure Assessment (SOFA) Score | Score 0-24, where higher scores are a worse outcome. | Postoperative day 1,2, day of postoperative echocardiography in all patients. In patients admitted to HDU/ICU, SOFA score will be collected from postoperative day 0-7. |
| Fifteen-point Quality of Recovery Score (QoR-15) | Fifteen questions assessing the quality of a patients recovery, each question is scored 0-10 with higher scores indicating a worse outcome. | Pre-operatively and day of postoperative echocardiography (day 2-4 postoperatively). |
| World Health Organisation Disability Assessment Schedule 2.0 (WHODAS 2.0) | WHODAS 2.0 is a self administered questionnaire that assesses a patient's health and disability. Twelve questions are scored 0-4, where a higher score indicates a worse outcome. | Preoperatively, and at day 30, day 90, and one year postoperatively. |
| EuroQoL Dimension Health Related Quality of Life Questionnaire (EQ-5D-5L) | EQ-5D-5L is a self administered questionnaire that assesses 5 dimensions of a patient's quality of life. Each dimension is scored 1-5, where a higher score indicates a worse outcome. | Preoperatively, and at day 30, day 90, and one year postoperatively. |
| Glasgow Royal Infirmary | Glasgow | G4 0SF | United Kingdom |
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| Queen Elizabeth University Hospital | Glasgow | G51 4TF | United Kingdom |
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| ID | Term |
|---|---|
| D018497 | Ventricular Dysfunction, Right |
| ID | Term |
|---|---|
| D018754 | Ventricular Dysfunction |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D004452 | Echocardiography |
| ID | Term |
|---|---|
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014463 | Ultrasonography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
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