Validation of 2 BladderScans for measuring bladder volume non-invasively.
- Registration Number
- NL-OMON26134
- Lead Sponsor
- Medical Centre Leeuwarden
- Brief Summary
Brouwer TA, Eindhoven BG, Epema AH, Henning RH. Validation of an Ultrasound Scanner for Determing Urinary Volumes in Surgical Patients and Volunteers. J Clin Monit Comput; 1999, 15(6), 379-385.<br> Brouwer TA. Retenton d'Urine et Anomalies de la Miction en Postoperatoire. Le Practicien en Anesthesie reanimation. 2003; 7(2), 129-135.<br> Keita H, Diouf E, Tubach F, Brouwer T, Dahmani S, Mantz J, Desmonts JM. Predictive Factors of early Postoperative Urinary Retention in the Postanesthesia Care Unit. Anest.Analg. 2005; 101(2), 592-596.<br> Brouwer TA, Rosier PFWM, Moons KGM, Zuithoff NPA, Roon EN Kalkman CJ. Postoperative Bladder Catheterization Based on Individual Bladder Capacity: A Randomized Trial. Anesthesiology. 2015, 122(1), 46-54.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 300
Adult patients (> 18 Y) who will be operated in the Medical Centre Leeuwarden needing a urinary catheter perioperatively and postoperative patients with a measured bladder volume larger than 500 ml and inability to void spontaneously provided written informed consent
Patients who have a suprapubic incision making the measurement impossible
Pregnancy
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The difference plus standard deviaton in volume in ml between the measured bladder volumes with the BladderScans, using the three different measuring methods, and the measured the urine volume retrieved after urinary.catheterization. Comparing 3 groups of 100 patients for each measurement type; first 100 patients with the BVI 9400, followed by 100 patients measured with the PRIME without pre-scan and than 100 patients measured with the PRIME using pre-scan.
- Secondary Outcome Measures
Name Time Method The difference in volume in ml between the measured bladder volume with the BladderScan and the measured urine volume after catheterization over the small to large urine volume ranges; i.e. quartiles of the measured urine volume after catheterization. Next to this, other possible relevant patient factors may influence the results and will be analyzed e.g. gender, age and BMI.