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

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ClinicalTrials.gov Identifier: NCT00912990
Recruitment Status : Terminated (Adequate subjects numbers not enrolled in study timeframe.)
First Posted : June 3, 2009
Last Update Posted : September 29, 2010
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment
Intubation Drug: Cisatracurium Drug: Normal saline

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pediatric Elective Intubation With and Without Muscle Relaxation Utilizing the Shikani Optical Stylet
Study Start Date : January 2007
Primary Completion Date : February 2008
Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Cisatracurium Drug: Cisatracurium
Placebo Comparator: Placebo Drug: Normal saline




Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00912990


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

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
First Posted: June 3, 2009    Key Record Dates
Last Update Posted: September 29, 2010
Last Verified: September 2010

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

Additional relevant MeSH terms:
Cisatracurium
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs