Influence of Premedication Protocols for Neonatal Endotracheal Intubation on Cerebral Oxygenation
Information source: University of Ulm
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Newborn; Preterm; Intubation
Intervention: Atropine, Fentanyl, Mivacurium (Drug); Atropine, Fentanyl, Mivacurium (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Ulm Official(s) and/or principal investigator(s): Manuel B Schmid, Dr. med., Principal Investigator, Affiliation: University of Ulm
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.
Clinical Details
Official title: The Influence of Two Different Premedication Protocols for Endotracheal Intubation in Neonates on Cerebral Oxygenation
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change of cerebral tissue oxygen saturation during premedication and intubation
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 .
Eligibility
Minimum age: N/A.
Maximum age: 44 Weeks.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- newborn infant below 44 weeks postmenstrual age
- indication for elective or semi-elective endotracheal Intubation
- parental informed consent
Exclusion Criteria:
- emergency intubation
Locations and Contacts
University Medical Center, Ulm, Baden-Württemberg 89075, Germany
Additional Information
Starting date: June 2011
Last updated: July 24, 2012
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