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

This study has been terminated.
(Adequate subjects numbers not enrolled in study timeframe.)
Sponsor:
Information provided by:
Rady Children's Hospital, San Diego
ClinicalTrials.gov Identifier:
NCT00912990
First received: June 1, 2009
Last updated: September 28, 2010
Last verified: September 2010
History of Changes
  Purpose

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.

Condition Intervention
Intubation
 Drug: Cisatracurium
Drug: Normal saline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pediatric Elective Intubation With and Without Muscle Relaxation Utilizing the Shikani Optical Stylet

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rady Children's Hospital, San Diego:

Enrollment: 35
Study Start Date: January 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cisatracurium Drug: Cisatracurium
Placebo Comparator: Placebo Drug: Normal saline

  Eligibility

Ages Eligible for Study:   6 Months to 17 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00912990

Locations
United States, California
Rady Children's Hospital
San Diego, California, United States, 92123
Sponsors and Collaborators
Rady Children's Hospital, San Diego
  More Information

No publications provided

Responsible Party: Sandeep Khanna, M.D./Principal Investigator, Rady Children's Hospital, San Diego. Division of Pediatric Critical Care
ClinicalTrials.gov Identifier: NCT00912990     History of Changes
Other Study ID Numbers: 11672
Study First Received: June 1, 2009
Last Updated: September 28, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Rady Children's Hospital, San Diego:
Pediatric

Additional relevant MeSH terms:
Muscle Hypotonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cisatracurium
 Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013