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NCT05902013 Clinical Trial

Video Laryngoscopy Versus Direct Laryngoscopy for Nasotracheal Intubation

Congenital Heart Disease Clinical Trial

Official title:
Video Laryngoscopy Versus Direct Laryngoscopy for Nasotracheal Intubation in Neonates and Infants With Congenital Heart Disease Less Than 1-year of Age Prior Cardiac Surgery: a Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05902013
Other study ID # 11352022
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 21, 2022
Est. completion date December 31, 2023

Study information
Verified date June 2023
Source Medical University of Vienna
Contact Eva M Base, MD
Phone +43140400
Email eva.base@meduniwien.ac.at
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group N/A to 1 Year
Eligibility Inclusion criteria. - Age less than 1 year - Congenital heart disease - Scheduled for cardiac surgery - Planned postoperative ICU stay Exclusion criteria - Nostrils not suitable for nasotracheal intubation - Bleeding during dilation of nostrils

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• laryngoscopy
laryngoscopy for nasotracheal intubation

Locations
Country Name City State
Austria Medical University Vienna Vienna

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary first attempt intubation success rate number study period, 30 minutes
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