Video Laryngoscopy Versus Direct Laryngoscopy for Nasotracheal Intubation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 1
SponsorMedical University of Vienna
About this trial
The aim of this study is to perform a pilot study investigating the first attempt intubation success rate differing between video laryngoscope nasotracheal intubation and direct laryngoscope nasotracheal intubation.
The study population will consist of 60 neonates and infants with congenital heart disease less than 1 year of age who need nasotracheal intubation during general anesthesia for cardiac procedures.
Standard nasotracheal intubation will be performed using either a video laryngoscope or direct laryngoscopy. Neonates and infants will be randomly assigned (1:1) to standard video laryngoscopy (with one of the following systems: Storz C-MAC Miller Video Laryngoscope, Karl Storz, Tuttlingen, Germany or Mc Grath Video Laryngoscope, Medtronic, Boulder,USA) or to direct laryngoscopy with one of the following blades: Miller or Macintosh (Heine, Hersching, Germany).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age less than 1 year
Congenital heart disease
Scheduled for cardiac surgery
Planned postoperative ICU stay
Disqualifiers
Nostrils not suitable for nasotracheal intubation
Bleeding during dilation of nostrils
Trial design
Design model
Parallel
Treatments tested in this trial
laryngoscopy
Devicelaryngoscopy for nasotracheal intubation
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: VideoActive comparator 1 intervention
Group B: DirectActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
first attempt intubation success rate
number
Time frame
study period, 30 minutesSponsors and contacts
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Source ClinicalTrials.gov