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Validation of Serenno CUO and IAP Measuring Device

NCT05121454 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 31

Last updated 2023-04-12

No results posted yet for this study

Summary

Serenno Medical Automatic Urine Output measuring device is intended to measure volumetric flow rate (total volume and rate) of urine produced per minute over long periods by a patient with a urinary catheter as well as high resolution IAP via bladder pressure (IBP). The device comprises a control unit located near the bed, and a disposable unit connected between the catheter and the urine collection tube/bag. The disposable unit is connected to the control unit with a tube.

Frequent and accurate Intra-Abdominal Pressure measurements facilitate management of critical care patients, yet this parameter is normally measured manually, intermittently, and inaccurately. Automating IAP measurement will increase responsiveness, reduce workload, and potentially improve outcomes. The investigators goal is to validate the accuracy urinary catheter estimates of IAP compared to the gold standard during the application of a wide range of pressures controlled by a validated closed-loop insufflation reference.

Primary Objective:

The study objective is to evaluate the accuracy of the Serenno Medical IAP measurements in patients with indwelling urinary catheters vs. the gold standard - the Foley Manometer

Conditions

  • Urinary Catheter
  • Laparoscopic Surgery

Interventions

DEVICE

Serenno Sentinel, model Alpha 2.0, software version: 8.0

intra-abdominal pressure measurements compared to a Foley Manometer at different insufflation pressures between 5 and 25 cmH20 at 30seconds intervals.

Sponsors & Collaborators

  • Tel-Aviv Sourasky Medical Center

    lead OTHER_GOV

Principal Investigators

  • Barak Cohen, MD · Vice Chair Division of Anesthesiology, Intensive Care Medicine and Pain management

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-15
Primary Completion
2022-03-07
Completion
2022-03-07

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05121454 on ClinicalTrials.gov