This study is a multicenter, randomized controlled study, with the urinary tract infection rate at the time of catheter insertion for 1 week as the primary end point. By comparing the clinical safety and effectiveness of two kinds of urethral catheters, to evaluate the clinical application effect of one kind of urethral catheters.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
136
The trial group was intervened with disposable sterile urinary catheter. The model of the trial group includes two chamber type (Fr8, Fr10, Fr12, Fr14, Fr16, Fr18, Fr20, Fr22, Fr24) and three chamber type (Fr16, Fr18, Fr20, Fr22, Fr24).
the control group was intervened with ultra smooth antibacterial catheter. The control group models include single chamber (6Fr, 8Fr, 10Fr, 12Fr, 14Fr, 16Fr, 18Fr, 20Fr, 22Fr, 24Fr), double chamber (6Fr, 8Fr, 10Fr, 12Fr, 14Fr, 16Fr, 18Fr, 20Fr, 22Fr, 24Fr, 26Fr, 28Fr, 30Fr), and three chamber (16Fr, 18Fr, 20Fr, 22Fr, 24Fr, 26Fr)
Liaoning Cancer Hospital & institute
Dalian, Liaoning, China
Urinary tract infection rate
In accordance with the "Diagnostic Criteria for Catheter associated Urinary Tract Infection" in the "Technical Guidelines for the Prevention and Control of Catheter associated Urinary Tract Infection (Trial)" formulated and issued by the Ministry of Health in 2011. Although the patient has no symptoms, he or she has endoscopic examination or catheterization within one week. If the number of Gram positive cocci colonies in urine culture ≥ 10 has 4 cfu/ml, and the number of Gram negative bacilli colonies ≥ 10 has 5 cfu/ml, he or she should be diagnosed as asymptomatic bacteriuria. If the patient has urinary tract irritation symptoms such as frequent urination, urgent urination, and painful urination, or has lower abdominal tenderness, renal area percussion pain, with or without fever (\>38.0 ℃), it is symptomatic bacteriuria.
Time frame: one week
Success rate of catheterization
The success of catheterization is based on the evaluation of each instrument, which can be placed at the catheterization site as expected and catheterization can be carried out smoothly.
Time frame: 10 minutes after catheterization
level of urethral irritation
Level 0, no discomfort at all; Grade I, slight discomfort, but tolerable; Grade II, moderate discomfort, intolerable, urgency of urination, urethral pain, abdominal distension; Grade III, severe discomfort, extremely intolerable, obvious distension of lower abdomen, urethral pain, urgency of urination, and the desire to pull out the catheter, accompanied by restlessness, increased heart rate, and elevated blood pressure.
Time frame: 10 minutes after catheterization
level of urethral irritation
Level 0, no discomfort at all; Grade I, slight discomfort, but tolerable; Grade II, moderate discomfort, intolerable, urgency of urination, urethral pain, abdominal distension; Grade III, severe discomfort, extremely intolerable, obvious distension of lower abdomen, urethral pain, urgency of urination, and the desire to pull out the catheter, accompanied by restlessness, increased heart rate, and elevated blood pressure.
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Time frame: 72 hours
level of urethral irritation
Level 0, no discomfort at all; Grade I, slight discomfort, but tolerable; Grade II, moderate discomfort, intolerable, urgency of urination, urethral pain, abdominal distension; Grade III, severe discomfort, extremely intolerable, obvious distension of lower abdomen, urethral pain, urgency of urination, and the desire to pull out the catheter, accompanied by restlessness, increased heart rate, and elevated blood pressure.
Time frame: one week
Incidence of device related adverse events
The safety of clinical use of the device was evaluated based on the incidence of adverse events related to the device that occurred after the subject placed the tube. Including: balloon leakage, rupture, catheter self falling off, difficulty in pulling out catheter, catheter blockage, urine retention, urine leakage, hematuria, urethral injury, etc; It can be judged according to clinical experience, and imaging methods can be used when necessary.
Time frame: 72 hours
Incidence of device related adverse events
The safety of clinical use of the device was evaluated based on the incidence of adverse events related to the device that occurred after the subject placed the tube. Including: balloon leakage, rupture, catheter self falling off, difficulty in pulling out catheter, catheter blockage, urine retention, urine leakage, hematuria, urethral injury, etc; It can be judged according to clinical experience, and imaging methods can be used when necessary.
Time frame: one week
time of catheter duration
Time from insertion to removal of catheter
Time frame: one week
rating of operation convenience
Including excellent: very convenient, good: relatively convenient, poor: poor convenience
Time frame: 10 minutes after catheterization
rate of packaging integrity
Time frame: 10 minutes after catheterization
rate of device defect rate
The package is damaged, the balloon cannot be inflated, and the balloon leaks or breaks
Time frame: 10 minutes after catheterization