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Video Laryngoscopy Versus Direct Laryngoscopy for Nasotracheal Intubation

Sponsor
Medical University of Vienna (Other)
Overall Status
Recruiting
CT.gov ID
NCT05902013
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
15.3
Anticipated Duration (Months)
3.9
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Device: laryngoscopy
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Sep 21, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. first attempt intubation success rate [study period, 30 minutes]

    number

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 1 Year
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical University Vienna Vienna Austria 1090

Sponsors and Collaborators

  • Medical University of Vienna

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eva M. Base, MD, PhD, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT05902013
Other Study ID Numbers:
  • 11352022
First Posted:
Jun 13, 2023
Last Update Posted:
Jun 13, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Eva M. Base, MD, PhD, Medical University of Vienna
Endotracheal intubation
Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital

Study Results

No Results Posted as of Jun 13, 2023