Video Laryngoscopy Versus Direct Laryngoscopy for Nasotra... | NCT05902013

Studies
Video Laryngoscopy Versus Direct Laryngoscopy for Nasotracheal Intubation

NCT05902013

Sponsor

Medical University of Vienna

Status

Recruiting

Last Update Posted

Sep 29, 2025Actual

Enrollment

180Estimated

Phase

Not Applicable

Conditions

Congenital Heart Disease
Airway Complication of Anesthesia

Interventions

laryngoscopy

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 21, 2022Actual

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

May 21, 2023

First Submission Date that Met QC Criteria

Jun 4, 2023

First Posted Date

Jun 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 23, 2025

Last Update Posted Date

Sep 29, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

180Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Video	Active Comparator	using video laryngoscopy for endotracheal intubation	Device: laryngoscopy
Direct	Active Comparator	using direct laryngoscopy	Device: laryngoscopy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
laryngoscopy	Device	laryngoscopy for nasotracheal intubation	Direct Video

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

1 Year

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eva M Base, MD	Contact	+43140400	4109	eva.base@meduniwien.ac.at
Thomas Wasserscheid, MD	Contact	+43140400	4109	thomas.wasserscheid@meduniwien.ac.at

Overall Officials

Name	Affiliation	Role
Eva M Base, MD	Medical University of Vienna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University Vienna	Recruiting	Vienna	State of Vienna	1090	Austria

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006330	Heart Defects, Congenital

Ancestor Terms

ID	Term
D018376	Cardiovascular Abnormalities
D002318	Cardiovascular Diseases
D006331	Heart Diseases
D000013	Congenital Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007828	Laryngoscopy

Ancestor Terms

ID	Term
D003948	Diagnostic Techniques, Respiratory System
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D004724	Endoscopy

Browse Leaves

Not provided

Browse Branches

Not provided