Video Laryngoscopy Versus Direct Laryngoscopy for Nasotracheal Intubation
Primary Purpose
Congenital Heart Disease, Airway Complication of Anesthesia
Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
laryngoscopy
Sponsored by
About this trial
This is an interventional treatment trial for Congenital Heart Disease focused on measuring Endotracheal intubation
Eligibility Criteria
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
Sites / Locations
- Medical University ViennaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Video
Direct
Arm Description
using video laryngoscopy for endotracheal intubation
using direct laryngoscopy
Outcomes
Primary Outcome Measures
first attempt intubation success rate
number
Secondary Outcome Measures
Full Information
NCT ID
NCT05902013
First Posted
May 21, 2023
Last Updated
June 4, 2023
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT05902013
Brief Title
Video Laryngoscopy Versus Direct Laryngoscopy for Nasotracheal Intubation
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 21, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease, Airway Complication of Anesthesia
Keywords
Endotracheal intubation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Video
Arm Type
Active Comparator
Arm Description
using video laryngoscopy for endotracheal intubation
Arm Title
Direct
Arm Type
Active Comparator
Arm Description
using direct laryngoscopy
Intervention Type
Device
Intervention Name(s)
laryngoscopy
Intervention Description
laryngoscopy for nasotracheal intubation
Primary Outcome Measure Information:
Title
first attempt intubation success rate
Description
number
Time Frame
study period, 30 minutes
10. Eligibility
Sex
All
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eva M Base, MD
Phone
+43140400
Ext
4109
Email
eva.base@meduniwien.ac.at
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Wasserscheid, MD
Phone
+43140400
Ext
4109
Email
thomas.wasserscheid@meduniwien.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva M Base, MD
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva M Base, MD
Phone
+43140400
Ext
41090
Email
eva.base@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Thomas Wasserscheid, MD
Phone
+43140400
Ext
41090
Email
thomas.wasserscheid@meduniwien.ac.at
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Video Laryngoscopy Versus Direct Laryngoscopy for Nasotracheal Intubation
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