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Validation of 2 BladderScans for measuring bladder volume non-invasively.


- candidate number25173
- NTR NumberNTR6057
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-aug-2016
- Secondary IDsRTPO 965  nWMO 132
- Public TitleValidation of 2 BladderScans for measuring bladder volume non-invasively.
- Scientific TitleValidation of the BladderScans BVI 9400 and PRIME; Ultrasound Scanners for Measuring Bladder Volume Non-invasively
- ACRONYM
- hypothesisThe newer BladderScan PRIME with real time echo images (= pre-scan) is more accurate in measuring bladder volumes than measuring bladder volume without pre-scan or than the older version of the BladdderScan; the BVI 9400. and
- Healt Condition(s) or Problem(s) studiedBladder catheterization, Bladder
- Inclusion criteriaAdult 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
- Exclusion criteriaPatients who have a suprapubic incision making the measurement impossible
Pregnancy
Patients with ascites
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 15-jun-2016
- planned closingdate31-dec-2016
- Target number of participants300
- InterventionsBringing in urinary catheters following the clinical protocols used in the MCL
- Primary outcomeThe 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 outcomeThe 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.
- TimepointsTo include 100 patients per each BladderScan will take about 5 tot 6 weeks .
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Tammo Brouwer
- CONTACT for SCIENTIFIC QUERIES Tammo Brouwer
- Sponsor/Initiator Medical Center Leeuwarden
- Funding
(Source(s) of Monetary or Material Support)
Verathon Inc, USA
- PublicationsBrouwer 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.
Brouwer TA. Retenton d'Urine et Anomalies de la Miction en Postoperatoire. Le Practicien en Anesthesie reanimation. 2003; 7(2), 129-135.
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.
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.
- Brief summaryIt is important to know the perioperative bladder volumes of surgical patients to prevent not only unnecessary bladder catheterizations but also to prevent bladder over distention. Non-invasive bladder volume measurement is possible, but how acurate are these devices in clinical practice and is the new PRIME, with new software and the possibility to pre-scan the bladder using real time echo images, more accurate than the its precessor the BVI 9400? We will found out.
- Main changes (audit trail)
- RECORD15-aug-2016 - 3-nov-2016


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