No registrations found.
ID
Source
Brief title
Health condition
hemodynamic insatbility during surgery
Sponsors and support
Intervention
Outcome measures
Primary outcome
comparison of hemodynamics and bio-parameters with Bland-Altman analysis.
Secondary outcome
other parameters by the device like saturation, heartrate, stroke volume
Background summary
The aim of the study is to compare three parameters of the MTX Gnoca (hemodynamics, hemocytometry and blood gas values) with the same values that are part of the standard care. Only if there are measurements performed on the patient as part of standard care, the tested device will be used. The Cnoga is a small device(comparable to a pulse oximeter) which is very easy to put on. Cnoga's technology is based on four Light Emitting Diodes (LED) in a finger compartment. These LEDs send visible to infrared light rays on the fingertip, where detection takes place. While the light wave passes through the tissue and blood capillaries, some of the light is absorbed which changes the light signal. The remaining light wave is then projected on a sensor. The image sensor detects realtime changes in tissue color and the signal is transmitted to a processor and with an algorithm bioparameters are calculated.
Study objective
Comparison of the MTX Gnoca with golden standard for bloodpressure, cardiac output, hemoglobin and arterial bloodgas analysis.
Study design
Collection of data within three months. data analysis in two months. writing of papers in 3 months.
Primary outcome:
Hemodynamics: three measurements at the start of the surgery, after placement of arterial catheter/PiCCO. Measurements of blood pressure (arterial catheter)/CO (PiCCO) and at the same time three measurements with the CNOGA device. measurements of the CNOGA are visible on screen and can be connected with a phone/tablet. the measurements of blood pressure with the arterial catheter are directly visible on the patient monitor. Cardiac output measurement is done according to the advise of the menufacturer
Hemocytometry/bloodgas analysis: at the start of surgery one bloodgas and/or hemoglobin measurement is done and send to the laboratory of the radboudumc. At te same time three measurements with the Cnoga are performed. the mean of these measurements are used for the comprison with the laboratory measurements.
Secondary outcome:
Other parmaters (saturation, heartrate, stroke volume) are measured in the same way as the hemodynamics. These measurements are directly visible on the patient monitor.
Intervention
none
Inclusion criteria
18 years or older
the patient must posses an arterial catheter, central line or PiCCO as part of their standard care.
Exclusion criteria
impossibility to place the MTX Gnoca
COVID-19 infection or suspected of infection.
Design
Recruitment
IPD sharing statement
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 |
|---|---|
| NTR-new | NL9164 |
| Other | CMO regio Arnhem - Nijmegen : CMO dossiernummer: 2020-6660 |