Video Laryngoscopy Versus Direct Laryngoscopy for Nasotracheal Intubation

NCT05902013 | Recruiting

• 1 other identifier: 11352022
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Congenital Heart Disease; Airway Complication of Anesthesia

Keywords

Endotracheal intubation

Outcome Measures

Primary Outcomes (1)

• first attempt intubation success rate

  number

  study period, 30 minutes

Study Arms (2)

Video

ACTIVE COMPARATOR

using video laryngoscopy for endotracheal intubation

Device: laryngoscopy

Direct

ACTIVE COMPARATOR

using direct laryngoscopy

Device: laryngoscopy

Interventions

laryngoscopy DEVICE

laryngoscopy for nasotracheal intubation

Direct; Video

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age less than 1 year
• Congenital heart disease
• Scheduled for cardiac surgery
• Planned postoperative ICU stay

You may not qualify if:

• Nostrils not suitable for nasotracheal intubation
• Bleeding during dilation of nostrils

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University Vienna

Vienna, Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Laryngoscopy

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Otorhinolaryngologic Surgical Procedures

Study Officials

• Eva M Base, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva M Base, MD

CONTACT

+43140400; eva.base@meduniwien.ac.at

Thomas Wasserscheid, MD

CONTACT

+43140400; thomas.wasserscheid@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 21, 2023
• First Posted: June 13, 2023
• Study Start: September 21, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)