Heart Disease, Pericardial Effusion, Pleural Effusion
Conditions
Keywords
cardiac surgery, postoperative treatment, pleural effusion, physical performance
Brief summary
One of the most common postoperative complications after open cardiac surgery is fluid accumulation between the pleural membranes or in the pericardial sac. This study investigates the consequence of such fluid accumulations on physical performance, recovery-time, cardiac and respiratory complications, and quality of life. Half of the participants will be followed closely and offered fluid drainage at a low threshold, and half of the participants will follow the current postoperative regimen.
Detailed description
Introduction: Knowledge concerning the impact of pleural and pericardial effusions on physical performance, recovery-time, cardiac and respiratory complications, and quality of life after open cardiac surgery is scarce. A more aggressive approach towards effusions has been suggested, but further studies are needed. Objectives: 1. to determine the size of pleural and pericardial effusion that results in at least 30% reduction of physical performance in the 6-minute walk test. 2. to compare the improvement in physical performance between the intervention group and the control group, measured from baseline to day 30 after surgery. Materials and methods: A randomised controlled intervention trial. Patients admitted for open cardiac surgery (aortic valve surgery, coronary artery bypass graft surgery and combinations) will be randomised into either an intervention group or a control group. The intervention group will be followed with physical tests and ultrasonic examination the month following surgery. Pleural or pericardial effusion of a predefined size will be drained. The control group will follow the current postoperative regimen.
Interventions
PROCEDUREpleuracentesis
Direct needle drainage of pleural effusions with dynamic ultrasound technique
Sponsors
Aarhus University Hospital Skejby
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>18 years. * Admitted for elective aortic valve surgery, coronary artery bypass graft surgery or combinations. * Be able to understand the written and oral patient information and to give informed consent.
Exclusion criteria
* Surgical combinations involving the mitral valve since they are already examined with full echocardiography prior to discharge, which may influence protocol driven decisions. * Simultaneous participation in any other clinical intervention trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in walking distance before and after intervention | day 4, day 15, day 30 | The primary outcome measure is the change in walking distance before and after pleuracentesis, subsequently the size of pleural effusion (both cm measured on ultrasound and drained volume) that results in a reduction of distance in the 6 minute walk test of at least 30%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in walking distance from baseline to day 30 after surgery | day 0 and day 30 | The difference in walking distance from before surgery (day 0) to after surgery (day 30) will be compared between the intervention arm (+ pleuracentesis) and the control arm (standard postoperative regimen) |
Other
| Measure | Time frame | Description |
|---|---|---|
| needle pleuracentesis versus pigtail catheter | day 0, day 4, day 15 and day 30 | To asses how much of the pleural effusion is drained when performing needle puncture instead of inserting a pigtail catheter. Secondary to compare the complication rate of the two procedures. |
Countries
Denmark
Outcome results
None listed