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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00912990
Recruitment Status : Terminated (Adequate subjects numbers not enrolled in study timeframe.)
First Posted : June 3, 2009
Results First Posted : August 12, 2020
Last Update Posted : August 18, 2020
Sponsor:
Information provided by (Responsible Party):
Sandeep Khanna, 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 Phase
Intubation,Endotracheal Drug: Cisatracurium Drug: Normal saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 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
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Normal saline
Normal saline volume calculated to be equal to the volume of cisatracurium 0.2mg/kg
Drug: Normal saline
One Intravenous dose

Active Comparator: Cisatracurium
Subjects in this arm will be given Cisatracurium 0.2mg/kg IV dose one time prior to intubation.
Drug: Cisatracurium
One intravenous dose: 0.2mg/kg/dose
Other Name: Nimbex




Primary Outcome Measures :
  1. Time to Intubation [ Time Frame: 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 :
  1. The Number of Adverse Events [ Time Frame: 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.


Other Outcome Measures:
  1. Number of Intubation Attempts for Each Enrolled Subject [ Time Frame: The number is totaled after successful endotracheal intubation is documented ]
    The total number of intubation attempts to achieve successful intubation of study participants.



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
Accepts Healthy Volunteers:   No
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
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United States, California
Rady Children's Hospital
San Diego, California, United States, 92123
Sponsors and Collaborators
Rady Children's Hospital, San Diego
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Responsible Party: Sandeep Khanna, Attending Physician Division of Pediatric Critical Care, Rady Children's Hospital, San Diego
ClinicalTrials.gov Identifier: NCT00912990    
Other Study ID Numbers: 11672
06104C ( Other Identifier: Rady Children's Hospital San Diego )
First Posted: June 3, 2009    Key Record Dates
Results First Posted: August 12, 2020
Last Update Posted: August 18, 2020
Last Verified: August 2020
Keywords provided by Sandeep Khanna, Rady Children's Hospital, San Diego:
Pediatric
Additional relevant MeSH terms:
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Cisatracurium
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs