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

• Status: Terminated
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rady Children's Hospital, San Diego
• Treatments: Cisatracurium

Criteria

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