Is it feasible to measure mean systemic filling pressure (Pmsf) and ΔetCO2 secondary to an incubator tilt maneuver in newborn infants?
ID
Source
Brief title
Condition
- Heart failures
- Neonatal and perinatal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The two study parameters are
• The mean systemic filling pressure (Pmsf), assessed with an extremity
occlusion test
• The change in end-tidal carbon dioxide pressure (ΔetCO2) in response to a
incubator tilting maneuver
Secondary outcome
Not applicable
Background summary
To ensure adequate perfusion and tissue oxygenation in neonates an adequate
filling pressure is necessary. In case of hypovolemia, a fluid bolus can be
life saving. However, volume expansion (VE) in an already hypervolemic neonate
is not without risk and is associated with disturbed neurological outcome,
increased prevalence of chronic lung disease and increased mortality. To avoid
adverse effects due to excessive fluid overload it is important to be able to
accurately predict if a fluid bolus does result in an increase in cardiac
output (CO), defined as *fluid responsiveness*. Recently, two new methods to
predict fluid responsiveness are described in adult patients: the change in
end-tidal CO2 (ΔetCO2) during passive leg raise (PLR) and the mean systemic
filling pressure (Pmsf). Both methods show promising results in adults.
However, these findings on fluid responsiveness in adults cannot simply be
extrapolated to neonates, since there is a rather large difference between
neonatal and adult physiology. Therefore we want to investigate the feasibility
of measuring ΔetCO2 and Pmsf in neonates in this pilot study.
Study objective
Is it feasible to measure mean systemic filling pressure (Pmsf) and ΔetCO2
secondary to an incubator tilt maneuver in newborn infants?
Study design
Prospective feasibility study
Study burden and risks
The procedure of Pmsf is comparable with non-invasive blood pressure
measurement. However, the duration of arterial occlusion will be longer, i.e.
30 seconds. This will result in a slight increase in discomfort in comparison
with regular non-invasive blood pressure measurement. The incubator tilt
maneuver is comparable with the tilting of the incubator and handling of the
patient that is performed during daily routine care. The Trendelenburg position
is avoided to prevent cerebral hyperperfusion. There are no benefits for the
patient related to this feasibility study.
Geert Grooteplein zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
• Arterial catheter in place, well functioning with the tip positioned in the radial artery or posterior tibial artery (for Pmsf measurement)
• Mechanical ventilation with capnography (for ΔetCO2 assessment)
• Informed consent obtained from parents or representatives
• Steady state as judged by the attending physician
Exclusion criteria
• Life-threatening congenital defects
• Perinatal asphyxia
• Intraventricular hemorrhage > grade 1
• Central venous catheter of peripheral infusion with administration of (cardiovascular) drugs, that can not be interrupted secondary to vascular occlusion for 30 seconds
• Condition in which an incubator tilt is contraindicated, such as for example external ventricular drainage;• Condition in which any handling is contraindicated
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 | NL45608.091.13 |