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| ID | Type | Description | Link |
|---|---|---|---|
| 06104C | Other Identifier | Rady Children's Hospital San Diego |
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Adequate subjects numbers not enrolled in study timeframe.
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal saline | Placebo Comparator | Normal saline volume calculated to be equal to the volume of cisatracurium 0.2mg/kg |
|
| Cisatracurium | Active Comparator | Subjects in this arm will be given Cisatracurium 0.2mg/kg IV dose one time prior to intubation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cisatracurium | Drug | One intravenous dose: 0.2mg/kg/dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
< 6 months of age, > 17 years of age
Difficult airway (Mallampati Classification)
History of previous difficult intubation, suspected abnormal airway: *micrognathia
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rady Children's Hospital | San Diego | California | 92123 | United States |
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Subjects were screened and enrolled at a single, pediatric hospital site.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Normal Saline | Normal saline volume calculated to be equal to the volume of cisatracurium 0.2mg/kg Normal saline : One Intravenous dose |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Normal Saline |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Unable to summarize data or complete analysis due to small study sample and technical problems with measurement leading to unreliable data. | Posted | Confirmed by the visualization of three carbon dioxide waveforms. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Laryngospasm | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sandeep Khanna | Rady Children's Hospital San Diego | 858-966-5863 |
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| ID | Term |
|---|---|
| C101584 | cisatracurium |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Normal saline | Drug | One Intravenous dose |
|
Normal saline volume calculated to be equal to the volume of cisatracurium 0.2mg/kg
Normal saline : One Intravenous dose
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | The Number of Adverse Events | The number of occurrences of each event. One subject may have multiple adverse events. | No further statistical analysis (intent-to-treat) completed due to small study sample. | Posted | Number | events | Recorded from the start of the intubation procedure to the time of successful endotracheal intubation |
|
|
|
| Other Pre-specified | Number of Intubation Attempts for Each Enrolled Subject | The total number of intubation attempts to achieve successful intubation of study participants. | Unable to analyze data due to small study sample. | Posted | The number is totaled after successful endotracheal intubation is documented |
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Normal Saline | Normal saline volume calculated to be equal to the volume of cisatracurium 0.2mg/kg Normal saline : One Intravenous dose | 0 | 18 | 3 | 18 |
| Participant movement/cough/gag | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Esophageal intubation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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