Davies, H.E., Mishra, E.K., Kahan, B.C., Wrightson, J.M., Stanton, A.E., Guhan, A., . . . Rahman, N.M. (2012). Effect of an indwelling pleural catheter vs chest tube and talc pleurodesis for relieving dyspnea in patients with malignant pleural effusion: The TIME2 randomized controlled trial. JAMA : The Journal of the American Medical Association, 307(22), 2383-2389.doi: 10.1001/jama.2012.5535
The objective of the study was to determine if indwelling pleural catheters (IPCs) are more effective than talc slurry pleurodesis via chest tube for relief of dyspnea.
Patients with symptomatic malignant pleural effusion requiring pleurodesis were randomized to either IPC or talc pleurodesis. IPCs were inserted, initial large-volume drainage was performed, and caregivers were trained in IPC management. Drainage was advised to be done three times weekly. The IPC was removed if significant drainage stopped for at least four weeks, with no evidence of fluid reaccumulation. Patients in the talc group were hospitalized and had percutaneous chest tube insertion and talc slurry pleurodesis with 4 g sterile high-grade talc, following published treatment guidelines. Patients were followed up for 12 months after randomization. Dyspnea measurement was recorded daily for 42 days and then at 10, 14, 18, 22, and 26 weeks, and at 9 and 12 months.
The study was conducted in multiple settings in the United Kingdom.
The study was an unblinded, randomized controlled trial.
Because it was unblinded, the study had the risk of bias.