To observe the possible relationship between central, conventional hemodynamic parameters with relatively new peripheral, regional perfusion parameters in two versions of a model with controlled vasocontriction (cooling) - vasodilation (heating)
ID
Source
Brief title
Condition
- Other condition
- Cardiac disorders, signs and symptoms NEC
Synonym
Health condition
hypothermie geïnduceerde patiënten
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To observe the effect of central and peripheral hypothermia induced by cooling,
on parameters of peripheral perfusion and central hemodynamic parameters.
Secondary outcome
- Evaluate the relationship between the different parameters of peripheral
perfusion during warming.
- Observe which interventions in the regular treatment (filling and inotropic)
effect parameters of the peripheral perfusion.
Background summary
Circulation of the body can be seen as consisting of a "central" and a
"peripheral" compartment. The central (systemic) compartment, roughly includes
the major blood vessels and is clearly ruled by cardiac function (stroke volume
and contractility). It can be stated that the regulation of the central
compartment, preferably serves the perfusion of the brain, which is the most
vital organ.
The nature and regulation of the peripheral compartment are difficult to
describe. First, non-vital organs (such as eg intestine and skin) can be
considered as part of the peripheral compartment, on the other hand extremity
(muscle, skin) are literally part of the peripheral circulation. Disruption of
the circulation as a whole often leads especially to changes in the peripheral
compartment. How the peripheral compartment behaves when heated, after
vasoconstriction, in relation to central perfusion, cardiac function and
interventions is still unknown.
Study objective
To observe the possible relationship between central, conventional hemodynamic
parameters with relatively new peripheral, regional perfusion parameters in two
versions of a model with controlled vasocontriction (cooling) - vasodilation
(heating)
Study design
This study is designed as a single-center observational study.
Study burden and risks
The microvascular peripheral perfusion is observed in all patients by
Sidestream Dark Field imaging, NIRS, PFI, delta temperature and capillary
refill time. This Sidestream Dark Field (SDF) imager is a new and more improved
method to observe the sublingual microcirculation at bedside, see page 9-11 of
the protocol for more explanation. All observations are not painful or
invasive. By placing the camera at the mucosa under the tongue a good SDF-image
can be made of the microvascular perfusion. Other parameters are assessed by
different stickers on the skin or chest. Peripheral perfusion parameters are
assessed one time only when the patient is warmed up at the ICU or CCU. SDF
images are assessed during the heating process by every 0.5 degree warming.
This represents no additional burden for the patient because the patient won*t
notice anything due to the anesthesia of the. No additional lines have to be
punctured.
's-gravendijkwal 230
3015 CE Rotterdam
Nederland
's-gravendijkwal 230
3015 CE Rotterdam
Nederland
Listed location countries
Age
Inclusion criteria
Healthy volunteers:
o Age 18 years or older and mentally competent
o Informed consent of the volunteer.;Elective post-cardiac surgery population:
o Age 18 years or older and mentally competent
o Informed consent from the patient
o Patients listed for elective cardiac surgery surgery (CABG).;Post CPR population:
o Age 18 years or older.
o Informed consent from the patient or legal representative.
o Patients admitted to the CCU after CPR and are therefore 24 hours chilled.
Exclusion criteria
Healthy volunteers:
o Pregnancy
o Failure to monitor peripheral perfusion by any reason;Elective post-cardiac surgery population:
o Pregnancy
o Bleeding in the oral cavity or other circumstances that make adequate SDF shooting impossible
o Failure to monitor peripheral perfusion by any reason;Post CPR population:
o Bleeding in the oral cavity or other circumstances that make adequate SDF recordings impossible.
o Failure to monitor peripheral perfusion by any reason
Design
Recruitment
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 | NL32590.078.10 |