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

Validation of the BladderScans BVI 9400 and PRIME; Ultrasound Scanners for Measuring Bladder Volume Non-invasively

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON26134

Enrollment

300

Registered

2016-08-15

Start date

2016-06-15

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Measuring bladder volume perioperatively is necessary to prevent uneccessary urinary catheterization but it is even more important in preventing Post Operative Urinary Retention and bladder distention. In het voorkomen van onnodige blaascatheterisatie en blaasoverrekking door een te volle blaas na de operatie is een juiste meting van de blaasinhoud zeer belanrijk. in dit onderzoek kijken we of de nieuwe BladderScan PRIME die ook met echte echobeelden kan werken nauwkeuriger is in het meten van

Interventions

Bringing in urinary catheters following the clinical protocols used in the MCL

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: Patients who have a suprapubic incision making the measurement impossible Pregnancy Patients with ascites

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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.	—

Contacts

Public ContactTammo Brouwer

Department of Anesthesia, Medical centre Leeuwarden

t.brouwer@znb.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)