Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00323531
Status:
COMPLETED
Last Update Posted:
2008-05-09
First Post:
2006-05-08
Brief Title:
Thoracoscopy Versus Fibrinolysis in Children With Empyema
Sponsor:
Childrens Mercy Hospital Kansas City
Organization:
Childrens Mercy Hospital Kansas City
Study Overview
Official Title:
Thoracoscopy Versus Fibrinolysis in Children With Empyema
Status:
COMPLETED
Status Verified Date:
2008-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The null hypothesis is that patients receiving either thoracoscopy or fibrinolysis for empyema recover in the same amount of time Therefore we will test this by randomizing the next 40 patients who consent to the study to one treatment or the other
Detailed Description:
This will be a single institution prospective randomized clinical trial involving patients who are found to have at least a single septation within a pleural effusion as diagnosed by ultrasound or computed tomography Additionally patients with a pleural effusion wherein a pleural tap reveals pus as defined by many 10000mm3 white blood cells or positive cultures will be considered This is intended to be a definitive study
Power calculations based on the known 48 post intervention hospital days after VATS and the estimated 7 post intervention days after fibrinolysis with α 005 and power of 08 show the need for 18 patients in each arm We will intend to recruit 40 This sample size was constructed in consultation with Dr Steve Simon and the range of hospital stay in our retrospective experience was utilized Therefore this number should represent an adequate power in spite of the known varied level of illness
One group will undergo thoracoscopy to clean the pleural space and leave a chest tube postoperatively to drainage The other group will undergo chest tube placement with subsequent infusion of fibrinolytics to dissolve the thick purulent material allowing drainage
Both groups will have the same antibiotic regimen with the same management algorithm
Power calculations based on the known 48 post intervention hospital days after VATS and the estimated 7 post intervention days after fibrinolysis with α 005 and power of 08 show the need for 18 patients in each arm We will intend to recruit 40 This sample size was constructed in consultation with Dr Steve Simon and the range of hospital stay in our retrospective experience was utilized Therefore this number should represent an adequate power in spite of the known varied level of illness
One group will undergo thoracoscopy to clean the pleural space and leave a chest tube postoperatively to drainage The other group will undergo chest tube placement with subsequent infusion of fibrinolytics to dissolve the thick purulent material allowing drainage
Both groups will have the same antibiotic regimen with the same management algorithm
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None