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IRCT20100816004578N7 IRCT 2019-03-14 Vice Chancellor for Research and Technology of Hamadan University of Medical Sciences Impact of two types of indwelling catheter in prevention catheter-associated urinary tract infectionson پیشگیری Comparison of two types of indwelling catheter in prevention catheter-associated urinary tract infections in ICU patients 2019-04-21 anticipated 80 Complete https://irct.ir/trial/37227 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: All patients with entry criteria will be identified. Then, the allocation of patients to the Foley catheter group or the LoPro urinary catheter will be randomized. The computer generated randomization list is first generated and the randomly assigned duplicate blocks (1: 1) are printed on paper and packed in envelopes. Each envelope will be opened after receiving written consent from the patient's ward, Blinding description: Since patients with a decreased level of consciousness, blind blindness is not conceptualized. The laboratory warden will not be aware of the groups being studied. Also, since the difference is only in the physical structure of the bladder end of the catheter and the visible parts in the two types of catheter are similar, therefore, nurses working in the ICU will not be aware of the type of catheter used for the patient. N/A Urinary tract infection. Intervention 1: Intervention group: In this group of a type of catheter with oval holes on both sides, the LoPro (Low Profile) catheter is a short and an end tip slightly higher than the balloon loop. Intervention 2: Control group:Use Foley Root Catheter in section. Yes - There is a plan to make this available What will be shared: All the studied demographic and clinical characteristics will be issued. When: The study protocol will be issued in the article. To whom: After publishing the results, the data will be provided to the requesting users. Conditions: The data will be available for use in the systematic review and meta-analysis studies. Where to obtain: Dr. Mahnaz Kitaban and Mrs. Farahnaz Ramezani (Project executives) How to obtain: By sending an email request to the project executives. Comments:
public Farshid Rahimi Bashar
General ICU, BESAT Hospital, Motahhari boulevard, Resalat Square, Hamedan
Hamedan Iran (Islamic Republic of) 6514845411 +98 81 3264 0025 frahimi@umsha.ac.ir Hamedan University of Medical Sciences scientific Farshid Rahimi Bashar
General ICU, BESAT Hospital, Motahhari boulevard, Resalat Square
Hamedan Iran (Islamic Republic of) 65148454411 +98 81 3264 0025 f.rahimi@umsh.ac.ir Hamedan University of Medical Sciences Iran (Islamic Republic of) Decreased consciousness (less than 9 in GCS) Normal body temperature (as axillary 35.5-37%) The doctor's order for urinary catheterization Not having a urinary tract infection or bacteriuria prior to admission Not having underlying diseases such as diabetes, CKD, nephrosclerosis, acute or chronic glomerulonephritis, and pyelonephritis Not having immune deficiency disorders such as lupus erythematosus, rheumatoid arthritis, MS Not having trauma and rupture of the urethra and bladder Not getting aminoglycoside medications Age over 18 years 18 years 85 years Both Exit the catheter for any reason (exits by patient or on doctor's instructions) before 3 days Death or transmission of the patient before the completion of the study N30.2 Other chronic cystitis Prevention Prevention Intervention group: In this group of a type of catheter with oval holes on both sides, the LoPro (Low Profile) catheter is a short and an end tip slightly higher than the balloon loop Control group:Use Foley Root Catheter in section Number Bacteria. Timepoint: Before and After 1،2،3 days. Method of measurement: Urine Culture. Type of Bacteria. Timepoint: Before and After 1،2،3 days. Method of measurement: Urine Culture. ESR. Timepoint: Before and After 3 days. Method of measurement: Vstrgryn. Leukocytosis. Timepoint: Before and After 3 days. Method of measurement: Cell Blood Count. Nitrite. Timepoint: Before and After 1.2.3 days. Method of measurement: Urinalysis. Body temperature. Timepoint: Before and After 1.2.3 days. Method of measurement: Axillary with medical thermometer. PH of the urine. Timepoint: Before and After 1.2.3 days. Method of measurement: DIP STICK. The color of the urine. Timepoint: Before and After 1.2.3 days. Method of measurement: DIP STICK. Vice Chancellor for Research and Technology of Hamadan University of Medical Sciences Approved 2019-01-28 Ethics Committee of Hamedan University of Medical Sciences Hamadan University of Medical Science, Shahid Fahmide boulevard, Hamadan Hamedan Hamadan Iran (Islamic Republic of)