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

NCT ID: NCT00912990

Last Updated: 2020-08-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2008-02-29

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.

Conditions

Intubation,Endotracheal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Normal saline

Normal saline volume calculated to be equal to the volume of cisatracurium 0.2mg/kg

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

One Intravenous dose

Cisatracurium

Subjects in this arm will be given Cisatracurium 0.2mg/kg IV dose one time prior to intubation.

Group Type: ACTIVE_COMPARATOR

Cisatracurium

Intervention Type: DRUG

One intravenous dose: 0.2mg/kg/dose

Interventions

Cisatracurium

One intravenous dose: 0.2mg/kg/dose

Intervention Type: DRUG

Normal saline

One Intravenous dose

Intervention Type: DRUG

Other Intervention Names

Nimbex

Eligibility 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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rady Children's Hospital, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Sandeep Khanna

Attending Physician Division of Pediatric Critical Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Rady Children's Hospital

San Diego, California, United States

Countries

United States

Other Identifiers

06104C

Identifier Type: OTHER

Identifier Source: secondary_id

11672

Identifier Type: -

Identifier Source: org_study_id