Video Laryngoscopy Versus Direct Laryngoscopy for Nasotracheal Intubation

NCT ID: NCT05902013

Last Updated: 2025-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-21

Study Completion Date

2025-12-31

Brief Summary

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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

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Conditions

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Congenital Heart Disease Airway Complication of Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Video

using video laryngoscopy for endotracheal intubation

Group Type ACTIVE_COMPARATOR

laryngoscopy

Intervention Type DEVICE

laryngoscopy for nasotracheal intubation

Direct

using direct laryngoscopy

Group Type ACTIVE_COMPARATOR

laryngoscopy

Intervention Type DEVICE

laryngoscopy for nasotracheal intubation

Interventions

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laryngoscopy

laryngoscopy for nasotracheal intubation

Intervention Type DEVICE

Eligibility Criteria

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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
Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Eva M. Base

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eva M Base, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

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Medical University Vienna

Vienna, Vienna, Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Eva M Base, MD

Role: CONTACT

+43140400 ext. 4109

Thomas Wasserscheid, MD

Role: CONTACT

+43140400 ext. 4109

Facility Contacts

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Eva M Base, MD

Role: primary

+43140400 ext. 41090

Thomas Wasserscheid, MD

Role: backup

+43140400 ext. 41090

Other Identifiers

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11352022

Identifier Type: -

Identifier Source: org_study_id

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