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

Intubation,Endotracheal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00912990
• Other study ID #: 11672
• Secondary ID: 06104C
• Status: Terminated
• Phase: N/A
• Start date: January 2007
• Est. completion date: February 2008

Study information

• Verified date: August 2020
• Source: Rady Children's Hospital, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Intubation,Endotracheal

Intervention

Drug:
• Cisatracurium
One intravenous dose: 0.2mg/kg/dose
• Normal saline
One Intravenous dose

Locations

Country	Name	City	State
United States	Rady Children's Hospital	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Rady Children's Hospital, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Intubation Attempts for Each Enrolled Subject	The total number of intubation attempts to achieve successful intubation of study participants.	The number is totaled after successful endotracheal intubation is documented
Primary	Time to Intubation	Time to intubation was defined as the time (seconds) required to verify three breaths on an end-tidal carbon dioxide monitor.	Confirmed by the visualization of three carbon dioxide waveforms.
Secondary	The Number of Adverse Events	The number of occurrences of each event. One subject may have multiple adverse events.	Recorded from the start of the intubation procedure to the time of successful endotracheal intubation