Pediatric Elective Intubation With and Without Muscle Relaxation Utilizing the Shikani Optical Stylet
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|ClinicalTrials.gov Identifier: NCT00912990|
Recruitment Status : Terminated (Adequate subjects numbers not enrolled in study timeframe.)
First Posted : June 3, 2009
Results First Posted : August 12, 2020
Last Update Posted : August 18, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Intubation,Endotracheal||Drug: Cisatracurium Drug: Normal saline||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
One intravenous dose: 0.2mg/kg/dose
Other Name: Nimbex
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00912990
|United States, California|
|Rady Children's Hospital|
|San Diego, California, United States, 92123|