Pediatric Elective Intubation With and Without Muscle Relaxation Utilizing the Shikani Optical Stylet

Rady Children's Hospital, San Diego34 enrolled

Overview

The investigators' primary specific aims are to demonstrate that: 1. Pediatric patients with normal airways, undergoing elective surgical procedures, can be successfully intubated when deeply sedated, without the use of muscle relaxants using the Shikani Optical Stylet. 2. Shikani intubation of pediatric patients is equally effective in children that are deeply sedated or paralyzed as evidenced by a non-significant difference in: * Time to intubation (defined as no more than a 30 second time difference between the two groups); * Incidence of adverse events.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Intubation,Endotracheal

Interventions

Cisatracurium

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 6 months of age to 17 years of age (not yet 18) * Male or female * English or Spanish speaking * Normal airway (Mallampati Classification ) * American Society of Anesthesiology Physical Status Classification I or II * Elective surgical procedure expected to last at least 45 minutes in length * Written informed consent/assent for participation given by the parent legal guardian and subject (if applicable) Exclusion Criteria: * \< 6 months of age, \> 17 years of age * Difficult airway (Mallampati Classification) * History of previous difficult intubation, suspected abnormal airway: \*micrognathia * facial trauma * airway tumor * epiglottitis * retropharyngeal abscess * foreign body, etc. * Scheduled for non-elective, emergent OR procedure * Parent, legal guardian, or subject is unavailable or unwilling to consent for study participation

Outcomes

Primary Outcomes

Time to Intubation

Time to intubation was defined as the time (seconds) required to verify three breaths on an end-tidal carbon dioxide monitor.

Time frame: Confirmed by the visualization of three carbon dioxide waveforms.

Secondary Outcomes

The Number of Adverse Events

The number of occurrences of each event. One subject may have multiple adverse events.

Time frame: Recorded from the start of the intubation procedure to the time of successful endotracheal intubation