TerminatedNCT00912990Updated Aug 18, 2020Results posted

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

An interventional study of Cisatracurium and Normal saline in Intubation,Endotracheal, sponsored by Rady Children's Hospital, San Diego. Terminated at 1 site in United States. Open to participants aged 6 Months to 17 Years. Per ClinicalTrials.gov, last updated 2020-08-18.

Sponsored by Rady Children's Hospital, San Diego · Not applicable, Interventional, and Treatment

Why this study was terminated

Adequate subjects numbers not enrolled in study timeframe.

Phase: Not applicable
Study type: Interventional
Enrollment: 34
Allocation: Randomized
Ages: 6 Months to 17 Years
Sex: All

Study summary

The investigators' primary specific aims are to demonstrate that:

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.
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 studied

Intubation,Endotracheal

Keywords

Pediatric

In context

Lead sponsor

Rady Children's Hospital, San Diego is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 6 Months to 17 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 34 participants (actual)

Study arms

Placebo comparator
Normal saline
Normal saline volume calculated to be equal to the volume of cisatracurium 0.2mg/kg
Drug: Normal saline
Active comparator
Cisatracurium
Subjects in this arm will be given Cisatracurium 0.2mg/kg IV dose one time prior to intubation.
Drug: Cisatracurium

Interventions

DrugCisatracurium
One intravenous dose: 0.2mg/kg/dose
Also known as: Nimbex
DrugNormal saline
One Intravenous dose

What researchers measure

Primary outcomes

Time to Intubation
Time to intubation was defined as the time (seconds) required to verify three breaths on an end-tidal carbon dioxide monitor.
Time frame: Confirmed by the visualization of three carbon dioxide waveforms.

Secondary outcomes

The Number of Adverse Events
The number of occurrences of each event. One subject may have multiple adverse events.
Time frame: Recorded from the start of the intubation procedure to the time of successful endotracheal intubation

Other outcomes

Number of Intubation Attempts for Each Enrolled Subject
The total number of intubation attempts to achieve successful intubation of study participants.
Time frame: The number is totaled after successful endotracheal intubation is documented

Results

Posted Aug 12, 2020

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.

Participant flow

Subjects were screened and enrolled at a single, pediatric hospital site.

Participant flow — Overall Study
Milestone	Cisatracurium	Normal Saline
Started	16	18
Completed	16	18
Not completed	0	0

Outcome measures

PrimaryTime to Intubation

Time to intubation was defined as the time (seconds) required to verify three breaths on an end-tidal carbon dioxide monitor.

Time frame:: Confirmed by the visualization of three carbon dioxide waveforms.

No measurements were reported for this outcome.

SecondaryThe Number of Adverse Events

The number of occurrences of each event. One subject may have multiple adverse events.

Time frame:: Recorded from the start of the intubation procedure to the time of successful endotracheal intubation
Reported as:: Number · events

The Number of Adverse Events
events	Cisatracurium	Normal Saline
The Number of Adverse Events	0	3

Other pre-specifiedNumber of Intubation Attempts for Each Enrolled Subject

The total number of intubation attempts to achieve successful intubation of study participants.

Time frame:: The number is totaled after successful endotracheal intubation is documented

No measurements were reported for this outcome.

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Cisatracurium	—	0/16 (0%)	0/16 (0%)
Normal Saline	—	0/18 (0%)	3/18 (16.7%)

Most frequent other events

Most frequent other events
Event	Cisatracurium	Normal Saline
LaryngospasmRespiratory, thoracic and mediastinal disorders	0/16	1/18
Participant movement/cough/gagRespiratory, thoracic and mediastinal disorders	0/16	1/18
Esophageal intubationRespiratory, thoracic and mediastinal disorders	0/16	1/18

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Cisatracurium	Normal Saline	Total
<=18 years	16	18	34
Between 18 and 65 years	0	0	0
>=65 years	0	0	0

Sex: Female, Male
Sex: Female, Male(Participants)	Cisatracurium	Normal Saline	Total
Female	5	8	13
Male	11	10	21

Region of Enrollment
Region of Enrollment(participants)	Cisatracurium	Normal Saline	Total
United States	16	18	34

Study locations

1 site

Rady Children's Hospital
San Diego, California 92123, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00912990
Lead sponsor: Rady Children's Hospital, San Diego
Responsible party: Sandeep Khanna (Attending Physician Division of Pediatric Critical Care, Rady Children's Hospital, San Diego) — Principal investigator
First posted: Jun 3, 2009
Start date: Jan 2007
Primary completion: Feb 2008
Completion: Feb 2008
Results posted: Aug 12, 2020
Last update: Aug 18, 2020

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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