Video Laryngoscopy Versus Direct Laryngoscopy for Nasotracheal Intubation

Medical University of Vienna

Status: Enrolling

Conditions: Airway Complication of Anesthesia; Congenital Heart Disease

Treatments: Device: laryngoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT05902013

11352022

Details and patient eligibility

About

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).

Enrollment: 180 estimated patients

Sex: All

Ages: Under 1 year old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

180 participants in 2 patient groups

Video

Active Comparator group

Description:

using video laryngoscopy for endotracheal intubation

Treatment:

Device: laryngoscopy

Direct

Active Comparator group

Description:

using direct laryngoscopy

Treatment:

Device: laryngoscopy