To obtain raw COqCO data for subsequent optimization of its working algorithm and to assess the agreement of COqCO with reference CO values in patients under general anaesthesia in whom fluid is administered. A secondary objective is to study the…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
monitoring van bloedsomloop tijdens anesthesie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Raw COqCO data, which includes impedance variables, will be collected as a
database and used for optimization and validation of the qCO algorithm
Also, the absolute value of RPVI, as obtained by the Masimo Radical 7 monitor,
and its fluid-induced change (*RPVI) will be assessed, in comparison to its
clinical reference, SVV.
Secondary outcome
- Comparison of the prediction of fluid responsiveness by RPVI with both
FloTrac/EV1000-derived SVV and traditional PVI.
- Ability of RPVI to predict fluid responsiveness, defined as an increase in CO
> 15%, and comparing it with the ability of SVV to predict fluid
responsiveness.
- Ability of SpHb to track changes in Hb concentration following fluid
administration by comparing it to reference (satellite-lab) Hb values.
Background summary
Technologic advances allow cardiac output (CO) to be monitored completely
noninvasively using impendance cardiography (COqCO). Also, cardiac preload
dependency can be assessed noninvasively using variations in plethysmography
(RPVI). In patients under general anaesthesia in whom fluid is administered,
the agreement of COqCO with clinical reference CO values is unknown, as well
the ability of RPVI to assess changes in preload dependency.
Previously, we have assessed the agreement of non-invasively determined Hb
concentration (SpHb) during ongoing liver surgery.12 Recent technical advances
have led to an update in the SpHb sensor and its underlying algorithm. The
effect of fluid administration on the reliability of SpHb in its current
version by comparing it with reference Hb values (i.e. satellite-lab Hb; ABL90
Flex, Radiometer, Copenhagen, Denmark), has not been assessed yet
Study objective
To obtain raw COqCO data for subsequent optimization of its working algorithm
and to assess the agreement of COqCO with reference CO values in patients under
general anaesthesia in whom fluid is administered. A secondary objective is to
study the influence of fluid administration on the ability of RPVI to reflect
preload dependency and to study the influence of a standardized fluid
administration on non-invasively measured haemoglobin concentration (SpHb).
Study design
Single-centre, low-risk, non-invasive interventional prospective study
Intervention
After induction of anaesthesia and once a steady state haemodynamic phase has
been reached before incision, all patients will be administered 5ml kg-1
crystalloids i.v. in 5-10 minutes. The haemodynamic response will be evaluated
by measuring COqCO, RPVI and the respective reference values, i.e.
FloTrac/EV1000 TM derived CO and stroke volume variation (SVV), respectively.
Study burden and risks
The sensors used for monitoring COqCO and RPVI are completely noninvasive and
pose no additional harm to the patient. Since only patients will be included in
whom no severe cardiopulmonary comorbidity is present, the risk of cardiac
decompensation secondary to the administration of 5 ml kg1- crystalloids is
negligible.
For evaluating SpHb changes, 2 blood samples (about 2.5ml each) will be drawn
before and after the fluid administration, from an indwelling arterial
catheter, of which the placement is standard care.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
* Patients scheduled for elective non-cardiac surgery requiring invasive
arterial blood pressure monitoring.
* Patients older than 18.
* ASA physical status I-III.
* Informed and willing to give written informed consent.
Exclusion criteria
* Patients who refuse to participate.
* Patients unable to consent (i.e. severe mental disorder, younger than 18).
* Patients with pacemakers.
* Patients with severe cardiac pathologies or hemodynamically unstable.
* Patients with end-stage renal failure.
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 | NL65093.042.18 |