The primary endpoint is the accuracy of urine production monitoring using the automated Flowsure monitor compared to the standard manual method of monitoring.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
de criculatie en de daarmee samenhangende urineproductie door de nieren
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome event in Part A will be the accuracy of urine measurement
over two set time interval (a nursing shift of 8 hours and a full 24 hours
period) using manual monitoring and automated monitoring. The gold standard
will be the total urine production measured in a measuring cup by draining the
collection bag.
The primary outcome in part B of the study will accuracy of measurement over a
set time interval (a nursing shift of 8 hours and a full 24 hours period) using
manual monitoring and automated monitoring. Additional the completeness of the
hourly diuresis registration will be compared between the manual and automated
measurement groups.
Secondary outcome
Not applicable
Background summary
Current manual diuresis monitoring is too labor intensive to optimally monitor
hospitalised patients with a urine catheter. The automated Flowsure monitor
aims to automate diuresis monitoring.
Study objective
The primary endpoint is the accuracy of urine production monitoring using the
automated Flowsure monitor compared to the standard manual method of
monitoring.
Study design
Part A is single arm intervention study in which patients will receive both the
manual monitors and automated Flowsure monitor (both devices will be used in
conjunction). Part B is a two-arm non-randomized non-blinded intervention study
in which patients will be monitored with either the manual monitoring or
automated Flowsure monitor (non-randomized and based on availability of the
automated monitor).
Intervention
In part A patient will undergo double urine monitoring as they receive both the
manual urine monitor and automated Flowsure monitor. In part B patients will be
randomized to monitoring with the manual monitor or to automated monitoring
with the automated Flowsure monitor.
Study burden and risks
There will likely be no direct benefit for patients participating in the study.
The societal/research benefit of the study lies in the potentially improved
diuresis monitoring and registration in the medical record of the patient which
will improve the quality of patient monitoring and therefore patient safety.
Risks: The foreseeable added risks associated with the use of Flowsure in Part
A are negligible as using the automated monitor will be additive to the manual
measurements. In part B patient will be monitored with either a manual monitor
or the automated flowsure monitor. The foreseeable added risks associated with
the use of Flowsure in part B is negligible because if Flowsure fails the
hourly urine production can be estimated by dividing the total urine collection
since monitoring started by the hours that have passed since insertion of the
urine catheter.
Risk-benefit analysis: Since the expected clinical-scientific benefit of this
study is estimated as large and the clinical investigation is, in the opinion
of the investigators, proportional to the added risk associated with the use of
the medical device which is estimated as low, the overall risk-benefit profile
of the study is favorable.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
- 18 years and older
- Currently hospitalized
- Currently for medical treatment (unrelated to the study have an urine
catheter inserted
- Willing and able to provide informed consent
Exclusion criteria
Patients who:
- Do not have a urine catheter inserted
- Are known to have chronically no diuresis (e.g. patients on dialysis).
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL84838.018.23 |