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IRCT20220117053750N1 IRCT 2022-02-28 Kerman University of Medical Sciences The Evaluation of effectiveness of betadine (Povidone-iodine) in one step and two step procedure in the treatment of patients with pleural effusion resistant to conventional treatments: a clinical trial The Evaluation of effectiveness of betadine (Povidone-iodine) in one step and two step procedure in the treatment of patients with pleural effusion resistant to conventional treatments: a clinical trial 2021-03-21 anticipated 40 Complete https://irct.ir/trial/61370 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 1-2 Resistant pleural effusion. Intervention group:In this study, 20 patients received betadine in one step. 20 cc of 10% betadine is injected with 60 cc of normal saline and 5 cc of lidocaine and the catheter is removed and two weeks after betadine injection is removed with a needle. In the second group, we inject 10 cc of betadine along with 30 cc of normal saline and 5 cc of lidocaine and hold the catheter. Two weeks later, we inject 10 cc of betadine with 30 cc of normal saline and 5 cc of lidocaine. Two hours after the injection, the catheter is closed and the position is changed, and after 2 hours, the catheter valve is opened again, and finally, after 24 hours, the catheter is removed, and the patients return two weeks later to remove the betadine. After the intervention, patients are cared for.. Yes - There is a plan to make this available What will be shared: The clinical results obtained from the study are published in the article while maintaining the confidentiality of patient data. When: The information obtained from the test results will be published in the article no later than 12 months later. To whom: Academic and scientific researchers Conditions: Academic and scientific researchers with the condition of maintaining the confidentiality of patients' information Where to obtain: Email the responsible author How to obtain: After requesting in the email and confirmation of the researcher, the requested information will be sent via Orchid two weeks later. Comments:
public Faranak Salajegheh
Emam Blv., Afzalipou Hospital
Kerman Iran (Islamic Republic of) 7616913355 +98 34 3132 8325 f.salajegheh@kmu.ac.ir Kerman University of Medical Sciences scientific Faranak Salajegheh
Emam Blv., Afzalipour Hospital
Kerman Iran (Islamic Republic of) 7616913355 +98 34 3132 8325 f.salajegheh@kmu.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) In this study, patients with refractory pleural effusion with adhesions and a history of VATS and thoracoscopy are eligible for the study. no limit no limit Both In contrast, patients who have a mass for whom catheterization is not possible will be excluded from the study process Treatment - Drugs Intervention group:In this study, 20 patients received betadine in one step. 20 cc of 10% betadine is injected with 60 cc of normal saline and 5 cc of lidocaine and the catheter is removed and two weeks after betadine injection is removed with a needle. In the second group, we inject 10 cc of betadine along with 30 cc of normal saline and 5 cc of lidocaine and hold the catheter. Two weeks later, we inject 10 cc of betadine with 30 cc of normal saline and 5 cc of lidocaine. Two hours after the injection, the catheter is closed and the position is changed, and after 2 hours, the catheter valve is opened again, and finally, after 24 hours, the catheter is removed, and the patients return two weeks later to remove the betadine. After the intervention, patients are cared for. Pleural effusion, reduction of pleural effusion. Timepoint: monthly. Method of measurement: Ultrasound of the pleural space. Reduce dyspnea and cough. Timepoint: One week after pleural effusion injection. Method of measurement: In this study, a data collection form (Checklist) will be used to collect data. This form consists of 4 main parts. In the first part, the demographic characteristics of patients, including age and sex, as well as the type of pleural effusion disease, which is benign and malignant, are recorded. In the second part, the form of thyroid and kidney enzymes are recorded before and after the intervention. In the third part of the form, the length of the follow-up period and the final outcome of the treatment, which includes the success of the treatment and the failure of the treatment, are recorded. Side effects and patient complaints including chest pain, fever, shortness of breath, hypotension, vision loss, and air leakage are recorded at the end of the form. Kerman University of Medical Sciences Approved 2022-01-22 Kerman University of Medical Sciences Emam Blv., Afzalipour Hospital Kerman Kerman Iran (Islamic Republic of)