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

Not Applicable

Terminated

• Conditions: Intubation,Endotracheal
• Interventions: Drug: Normal saline; Drug: Cisatracurium

• Registration Number: NCT00912990
• Lead Sponsor: Rady Children's Hospital, San Diego

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Study First Submitted: 2009-06-01
• Study First Submitted QC: 2009-06-01
• Study First Posted: 2009-06-03
• Results First Submitted: 2012-07-23
• Status Verified: 2020-08
• Results First Submitted QC: 2020-08-10
• Last Update Submitted: 2020-08-11
• Results First Posted: 2020-08-12
• Last Update Posted: 2020-08-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal saline	Normal saline	Normal saline volume calculated to be equal to the volume of cisatracurium 0.2mg/kg
Cisatracurium	Cisatracurium	Subjects in this arm will be given Cisatracurium 0.2mg/kg IV dose one time prior to intubation.

Primary Outcome Measures

Name	Time	Method
Time to Intubation	Confirmed by the visualization of three carbon dioxide waveforms.	Time to intubation was defined as the time (seconds) required to verify three breaths on an end-tidal carbon dioxide monitor.

Secondary Outcome Measures

Name	Time	Method
The Number of Adverse Events	Recorded from the start of the intubation procedure to the time of successful endotracheal intubation	The number of occurrences of each event. One subject may have multiple adverse events.

Trial Locations

Locations (1)

Rady Children's Hospital; 🇺🇸 San Diego, California, United States