Intubation,Endotracheal
Conditions
Keywords
Pediatric
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.
Interventions
DRUGCisatracurium
One intravenous dose: 0.2mg/kg/dose
DRUGNormal saline
One Intravenous dose
Sponsors
Rady Children's Hospital, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 17 Years
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
* \< 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Intubation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Adverse Events | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Intubation Attempts for Each Enrolled Subject | The number is totaled after successful endotracheal intubation is documented | The total number of intubation attempts to achieve successful intubation of study participants. |
Countries
United States
Participant flow
Recruitment details
Subjects were screened and enrolled at a single, pediatric hospital site.
Participants by arm
| Arm | Count |
|---|---|
| Cisatracurium Subjects in this arm will be given Cisatracurium 0.2mg/kg IV dose one time prior to intubation.
Cisatracurium : One intravenous dose: 0.2mg/kg/dose | 16 |
| Normal Saline Normal saline volume calculated to be equal to the volume of cisatracurium 0.2mg/kg
Normal saline : One Intravenous dose | 18 |
| Total | 34 |
Baseline characteristics
| Characteristic | Cisatracurium | Normal Saline | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 16 Participants | 18 Participants | 34 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 16 participants | 18 participants | 34 participants |
| Sex: Female, Male Female | 5 Participants | 8 Participants | 13 Participants |
| Sex: Female, Male Male | 11 Participants | 10 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 3 / 18 |
| serious Total, serious adverse events | 0 / 16 | 0 / 18 |
Outcome results
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.
Time frame: Confirmed by the visualization of three carbon dioxide waveforms.
Population: Unable to summarize data or complete analysis due to small study sample and technical problems with measurement leading to unreliable data.
Secondary
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
Population: No further statistical analysis (intent-to-treat) completed due to small study sample.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cisatracurium | The Number of Adverse Events | 0 events |
| Normal Saline | The Number of Adverse Events | 3 events |
Other Pre-specified
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
Population: Unable to analyze data due to small study sample.