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

• Males or females age 0 to <12 months.
• 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.
• Subject/Parental/guardian permission (informed consent).

Inclusion for clinician participants:

• Pediatric anesthesia attending, pediatric anesthesia fellows, and anesthesia resident

Exclusion criteria

• History of difficult intubation
• History with abnormal airway
• Predictive of difficult intubation upon physical examination
• Parents/guardians who, in the opinion of the investigator, may be unable to understand or give informed consent