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

NCT00912990 | Terminated Results

• 2 other identifiers: 1167206104C
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators' primary specific aims are to demonstrate that:

• Time to intubation (defined as no more than a 30 second time difference between the two groups);
• Incidence of adverse events.

Conditions

Intubation,Endotracheal

Keywords

Pediatric

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The Number of Adverse Events

  Recorded from the start of the intubation procedure to the time of successful endotracheal intubation

Other Outcomes (1)

• Number of Intubation Attempts for Each Enrolled Subject

  The number is totaled after successful endotracheal intubation is documented

Study Arms (2)

Normal saline

PLACEBO COMPARATOR

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

Drug: Normal saline

Cisatracurium

ACTIVE COMPARATOR

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

Drug: Cisatracurium

Interventions

Cisatracurium DRUG

One intravenous dose: 0.2mg/kg/dose

Also known as: Nimbex

Cisatracurium

Normal saline DRUG

One Intravenous dose

Normal saline

Eligibility Criteria

• Age: 6 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• \< 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

Sponsors & Collaborators

• Rady Children's Hospital, San Diego: lead

Study Sites (1)

Rady Children's Hospital

San Diego, California, 92123, United States

Location

MeSH Terms

Interventions

cisatracurium; Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

Inadequate subject numbers led to early termination. Unable to adequately power the study for data analysis. OAE data reported for transparency only and should not be used to extrapolate significant conclusions.

Results Point of Contact

• Title: Dr. Sandeep Khanna
• Organization: Rady Children's Hospital San Diego

858-966-5863

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician Division of Pediatric Critical Care

Study Record Dates

• First Submitted: June 1, 2009
• First Posted: June 3, 2009
• Study Start: January 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: August 18, 2020
• Results First Posted: August 12, 2020

Record last verified: 2020-08

Locations

US (1)