Intubation, Newborn, Preterm
Conditions
Brief summary
The purpose of this study is to examine the influence of premedication drugs Atropin, Fentanyl and Mivacurium and of endotracheal intubation on cerebral oxygenation and cardiac output in term and preterm newborn infants. Two different protocols of premedication are compared.
Detailed description
Influence of the following procedures will be examined: * Application of Atropin * Application of Fentanyl * Application of Mivacurium * possible desaturation and / or bradycardia during intubation attempts * restoration of arterial oxygen saturation and / or heart rate after succesful intubation We aim to examine the change of the following parameters by the use of electrical cardiometry: * stroke volume * cardiac output We compare two different premedication protocols and we evaluate the impact of these protocol on the time needed for intubation and on intubation difficulties .
Interventions
DRUGAtropine, Fentanyl, Mivacurium
1. Atropin 10µg/kg 2. Mivacurium 200µg/kg immediately followed by 3. Fentanyl 2µg/kg
Sponsors
University of Ulm
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 44 Weeks
Healthy volunteers
No
Inclusion criteria
* newborn infant below 44 weeks postmenstrual age * indication for elective or semi-elective endotracheal Intubation * parental informed consent
Exclusion criteria
* emergency intubation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of cerebral tissue oxygen saturation during premedication and intubation | from 1 minute before first study drug until 10 minutes after end of procedure | A baseline value of cerebral tissue oxygen saturation before first application of premedication drugs is determined. Change of cerebral tissue oxygen saturation is defined as area under this threshold from first drug application until recovery. |
Countries
Germany
Outcome results
None listed