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

• ClinicalTrials.gov Identifier: NCT00912990
• Recruitment Status: Terminated
• First Posted: June 3, 2009
• Results First Posted: August 12, 2020
• Last Update Posted: August 18, 2020
• Sponsor: Rady Children's Hospital, San Diego
• Information provided by (Responsible Party): Sandeep Khanna, Rady Children's Hospital, San Diego

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

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

• 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
• 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:

Cisatracurium; Neuromuscular Blocking Agents; Neuromuscular Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs