The Videolaryngoscopy in Small Infants

Objectives:

- Primary Objective To compare the tracheal intubation (TI) first attempt success rate
using VL vs. DL in children ≤ 12 months old.

- Secondary Objectives To compare the lowest oxygen saturation during tracheal intubation
with VL vs. DL.

Study Design:

Prospective, randomized, multi-center parallel group trial

Setting/Participants:

This will be a multi-center study with a minimum of four participating centers. The target
population will be children ≤ 12 months age scheduled for elective surgery requiring general
anesthesia with endotracheal intubation.

Study Interventions and Measures:

The study intervention will be a 1:1 randomization to perform tracheal intubation with the
Storz C-Mac Miller 1 (VL) or the conventional Miller laryngoscope (DL).

Main study outcome measures are as follows:

- The first intubation attempt success rate with each device

- The number of attempts for successful intubation with each device

- Complications associated with intubation

Inclusion Criteria

1. Males or females age 0 to <12 months.

2. Scheduled for non-cardiac surgery or procedure lasting longer than 30 minutes under
general anesthesia where oral endotracheal intubation will be performed by an
anesthesiology clinician.

3. Subject/Parental/guardian permission (informed consent).

Inclusion for clinician participants:

1. Pediatric anesthesia attending, pediatric anesthesia fellows, and anesthesia resident

2. Complete the manikin training and watching study training video

3. Willing to provide professional training and device experiences

4. Scheduled to perform intubation on a consented VISI patient

Exclusion Criteria

1. History of difficult intubation

2. History with abnormal airway

3. Predictive of difficult intubation upon physical examination

4. Parents/guardians who, in the opinion of the investigator, may be unable to understand
or give informed consent

Exclusion for clinician participants:

Anesthesia attending who does not have VL experiences in infant