Clinical Trial: Thoracoscopy Versus Fibrinolysis in Children With Empyema

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Thoracoscopy Versus Fibrinolysis in Children With Empyema

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 Summary:

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 (> 10,000/mm3 ) white blood cells or positive cultures will be considered. This is intended to be a definitive study.

Power calculations based on the known 4.8 post intervention hospital days after VATS and the estimated 7 post intervention days after fibrinolysis with α = 0.05 and power of 0.8 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.

Sponsor: Children's Mercy Hospital Kansas City

Current Primary Outcome: Length of hospitalization after intervention [ Time Frame: 1 month ]

Original Primary Outcome: Days to meeting discharge criteria after intervention

Current Secondary Outcome: Days where a maximum temperature was equal to or above 38 degrees C, days of tube drainage, doses of analgesia and days of oxygen requirement, hospital days after intervention, hospital charges after intervention and procedure charges [ Time Frame: 1 month ]

Original Secondary Outcome: Days where a maximum temperature was equal to or above 38C, days of tube drainage, doses of analgesia and days of oxygen requirement, hospital days after intervention, hospital charges after intervention and procedure charges

Information By: Children's Mercy Hospital Kansas City

Dates:
Date Received: May 8, 2006
Date Started: March 2006
Date Completion:
Last Updated: May 6, 2008
Last Verified: May 2008