Pleural and Pericardial Effusion Following Open Heart Surgery (IMAGING)
Knowledge concerning the impact of pleural and pericardial effusions on physical performance, recovery-time, cardiac and respiratory complications, and quality of life after open heart surgery is scarce. A more aggressive approach towards effusions has been suggested, but further studies are needed.
- 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.
- 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 heart-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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Clinical Impact of an Aggressive Approach Towards Pleural and Pericardial Effusions Following Open Heart Surgery: a Step Towards Standard Guidelines|
- change in walking distance before and after intervention [ Time Frame: day 4, day 15, day 30 ] [ Designated as safety issue: No ]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%.
- change in walking distance from baseline to day 30 after surgery [ Time Frame: day 0 and day 30 ] [ Designated as safety issue: No ]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)
- needle pleuracentesis versus pigtail catheter [ Time Frame: day 0, day 4, day 15 and day 30 ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||September 2013|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
No Intervention: current postoperative regimen
The group will follow the current postoperative regimen at the surgical ward; screening for pleural effusions with x-ray and further diagnostic procedures in case of symptoms. Treatment will be entirely in the hands of the clinical personnel.
The group will follow the current postoperative regimen. In addition they will be followed with ultrasound examination, clinical examination, spirometry examination and 6 minute walk test. In case of either a) pleural effusion > 400ml OR b) pleural effusion< 400ml with symptoms in rest or during the walk test, the effusion will be drained and examinations will be repeated. In case of pericardial effusion of predefined size and location, either the surgeon on call or a cardiologist will be consulted.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02045641
|Contact: Vibeke E. Hjortdal, MD DMSc PhDfirstname.lastname@example.org|
|Aarhus University Hospital||Recruiting|
|Aarhus N, Denmark, 8200|
|Contact: Laura Sommer Hansen, MD, PhD fellow +45 78451199 email@example.com|
|Principal Investigator: Laura Sommer Hansen, MD, PhD fellow|
|Study Director:||Vibeke E. Hjortdal, MD PHD DMSc||Aarhus University Hospital|