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| Name | Class |
|---|---|
| Florida International University | OTHER |
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The purpose of this study is to evaluate if intubation with video laryngoscopy (VL) will result in less head motion and therefore less cervical motion when compared with direct laryngoscopy (DL).
The aim of the study is to determine the amount of head motion (extension, flexion and rotation) when using Storz C-Mac® video laryngoscopes and direct laryngoscopes. Secondarily, the study will also measure the number of attempts to properly intubate and the time required for intubation with either technique.
Investigator initiated single site prospective and randomized controlled trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Video Laryngoscopy | Experimental | Some patients will be intubated with a video laryngoscope 'Storz C-Mac® laryngoscope' |
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| Direct Laryngoscopy | Active Comparator | Some patients will be intubated with a direct (conventional) laryngoscope |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Video Laryngoscopy | Procedure | Head motion will be measured by using Polhemus Patriot™ electromagnetic tracking system |
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| Measure | Description | Time Frame |
|---|---|---|
| Head Motion - Extension or Flexion | Head motion will only be measured while the patient is being endotracheally intubated. Usually this takes less than one minute. No follow up after that. | During the process of intubation (less than one minute) |
| Measure | Description | Time Frame |
|---|---|---|
| Time for Intubation | Time from when the laryngoscope blade enters the mouth until the endotracheal tube enters the vocal cords. No follow up after that. | During the process of intubation (less than one minute) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose Vargas Loayza, MD | Miami Children's Hospital Pediatric Emergency Medicine Fellow | Principal Investigator |
| Vincenzo Maniaci, MD | Miami Children's Hospital Pediatric Emergency Medicine Attending | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami Children's Hospital | Miami | Florida | 33155 | United States |
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| Label | URL |
|---|---|
| Miami Children's Hospital Research Institute Website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Video Laryngoscopy | Some patients will be intubated with a video laryngoscope Video Laryngoscopy: Head motion will be measured by using Polhemus Patriot™ electromagnetic tracking system Storz C-Mac® laryngoscope |
| FG001 | Direct Laryngoscopy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Direct Laryngoscopy | Procedure | Time for intubation will be measured from the laryngoscope entering the mouth to the endotracheal tube passing through the vocal cords |
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| Storz C-Mac® laryngoscope | Device |
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Some patients will be intubated with a direct (conventional) laryngoscope Direct Laryngoscopy: Time for intubation will be measured from the laryngoscope entering the mouth to the endotracheal tube passing through the vocal cords Storz C-Mac® laryngoscope |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Video Laryngoscopy | Some patients will be intubated with a video laryngoscope Video Laryngoscopy: Head motion will be measured by using Polhemus Patriot™ electromagnetic tracking system Storz C-Mac® laryngoscope |
| BG001 | Direct Laryngoscopy | Some patients will be intubated with a direct (conventional) laryngoscope Direct Laryngoscopy: Time for intubation will be measured from the laryngoscope entering the mouth to the endotracheal tube passing through the vocal cords Storz C-Mac® laryngoscope |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Head Motion in degrees | The primary measure was the degree of head motion which were maximum angles achieved with extension, flexion and rotation | Mean | Standard Deviation | participants |
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| 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 | Head Motion - Extension or Flexion | Head motion will only be measured while the patient is being endotracheally intubated. Usually this takes less than one minute. No follow up after that. | Posted | Mean | Standard Deviation | degrees of extension | During the process of intubation (less than one minute) |
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| Secondary | Time for Intubation | Time from when the laryngoscope blade enters the mouth until the endotracheal tube enters the vocal cords. No follow up after that. | Posted | Mean | Standard Deviation | second | During the process of intubation (less than one minute) |
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Adverse events were considered from time of initiating intubation until successful tracheal intubation
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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 | Video Laryngoscopy | Some patients will be intubated with a video laryngoscope Video Laryngoscopy: Head motion will be measured by using Polhemus Patriot™ electromagnetic tracking system Storz C-Mac® laryngoscope | 0 | 46 | 0 | 46 | 0 | 46 |
| EG001 | Direct Laryngoscopy | Some patients will be intubated with a direct (conventional) laryngoscope Direct Laryngoscopy: Time for intubation will be measured from the laryngoscope entering the mouth to the endotracheal tube passing through the vocal cords Storz C-Mac® laryngoscope | 0 | 46 | 0 | 46 | 0 | 46 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose M. Vargas Loayza, M.D. | Nicklaus Children's Hospital | 786-624-3588 | jose.vargas-loayza@mch.com |
| Male |
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| Flexion |
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| Rotation Right |
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| Rotation Left |
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