Validation of Serenno CUO and IAP Measuring Device

NCT05121454 | Completed

• 1 other identifier: 0406-21-TLV
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Accuracy of intra-abdominal pressure measurements according to the study device

  Intra-abdominal pressure in mmHg compared to measurements from a Foley Manometer at different insufflation pressures between 8 and 25 cmH20 at 30-seconds intervals.

  10 minutes prior to surgery

Interventions

Serenno Sentinel, model Alpha 2.0, software version: 8.0 DEVICE

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients undergoing laparoscopic surgical procedure requiring an indwelling urinary catheter.

You may qualify if:

• Male and female patients aged 18 years or more.
• Patients scheduled for laparoscopic surgical procedure requiring an indwelling urinary catheter.
• Providing informed consent.

You may not qualify if:

• Known urological pathology
• Known pregnancy
• Cognitive and/or psychiatric impairment precluding informed consent.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Division of Anaesthesia, Intensive Care, and Pain Management, Tel-Aviv Medical Center

Tel Aviv, 6423906, Israel

Location

Study Officials

• Barak Cohen, MD

  Vice Chair Division of Anesthesiology, Intensive Care Medicine and Pain management

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair Division of Anesthesiology, Intensive Care Medicine and Pain management, Tel-Aviv Medical Center, Sackler faculty of medicine, Tel-Aviv University, Israel

Study Record Dates

• First Submitted: October 31, 2021
• First Posted: November 16, 2021
• Study Start: November 15, 2021
• Primary Completion: March 7, 2022
• Study Completion: March 7, 2022
• Last Updated: April 12, 2023

Record last verified: 2023-04

Locations

IL (1)