Video Laryngoscopy Versus Direct Laryngoscopy for Nasotracheal Intubation

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

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).

Study Overview

• Status: Recruiting
• Conditions: Congenital Heart Disease; Airway Complication of Anesthesia
• Intervention / Treatment: Device: laryngoscopy

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eva M Base, MD; Phone Number: 4109 +43140400; Email: eva.base@meduniwien.ac.at
• Study Contact Backup: Name: Thomas Wasserscheid, MD; Phone Number: 4109 +43140400; Email: thomas.wasserscheid@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • Medical University Vienna
    • Contact: Eva M Base, MD; Phone Number: 41090 +43140400; Email: eva.base@meduniwien.ac.at
    • Contact: Thomas Wasserscheid, MD; Phone Number: 41090 +43140400; Email: thomas.wasserscheid@meduniwien.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Video; using video laryngoscopy for endotracheal intubation	Device: laryngoscopy; laryngoscopy for nasotracheal intubation
Active Comparator: Direct; using direct laryngoscopy	Device: laryngoscopy; laryngoscopy for nasotracheal intubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
first attempt intubation success rate	number	study period, 30 minutes

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: Eva M Base, MD, Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2022
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: May 21, 2023
• First Submitted That Met QC Criteria: June 4, 2023
• First Posted (Actual): June 13, 2023

Study Record Updates

• Last Update Posted (Actual): June 13, 2023
• Last Update Submitted That Met QC Criteria: June 4, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Endotracheal intubation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: 11352022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No