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Nasal intubation is frequently used for dental procedures to promote an unimpeded view of the oral cavity. A nasal RAE endotracheal tube is longer than a standard oral endotracheal tube (ETT) and it is shaped so that end of the tube which attaches to the ventilator exits upward toward the forehead. This unique shape ensures that the tube will not interfere with surgical exposure of the oral cavity and mandible. The nasal RAE ETT can be placed in the trachea using either direct laryngoscopy (DL) or video laryngoscopy (C-Mac) . Sometimes this is possible without an adjuvant, but frequently a pair of specially shaped forceps, known as Magill forceps, is required to guide the distal tip of the Nasal RAE into the glottis due to the curvature of these ETT. Magill forceps are introduced into the mouth and are used to grasp the distal end of the Nasal RAE and direct it into the glottis. Contrary to what the current literature suggests, it has been our experience that nasal intubations using the C-Mac frequently do not require the use of Magill forceps at nearly the same rate as DL. This technique may improve the time and ease to intubation because of not having to use the Magill forceps. The use of Magill forceps can be awkward for the clinician, with poor visualization due to obstruction of the view by this tool in the airway, and small working space within the posterior oropharynx. For these reasons, the possibility of not having to use Magill forceps because the investigators are using a C-Mac as the only tool to intubate is a potentially inviting one.
The objective of this study is to compare the need for the use of standard Magill forceps when performing a nasal intubation with either conventional DL or VL with a C-Mac. Secondarily the investigators will also examine the time to intubate (TTI) for both methods as well.
Once the patient is recruited, the patient will then be randomized to either intubation using DL or VL with a C-Mac. Once the patient is under anesthesia, the intubation will be performed by an attending pediatric anesthesiologist or experience pediatric CRNA who has experience both DL and with the C-Mac and will attempt to intubate the patient with or without Magill forceps as needed.
The investigators will record the time to intubation (TTI) from the time the laryngoscope or C-Mac is placed in the mouth to the first appearance of end tidal carbon dioxide (ETCO2). the investigators will record the presence or absence of nasal bleeding, and the grade of laryngeal view. The investigators will also record any general narrative comments about the ease or difficulty of intubation in both groups.
The study will be performed at Wake Forest Baptist Medical Center.
Patients between the ages of 3 and 14 scheduled for comprehensive dental treatment under general anesthesia will be included.
Normal appearing airway upon pre-operative assessment. The investigators have calculated a sample size of 35 patients in each group to be able to detect a significant difference in the rate of use of Magill forceps to place a nasal RAE ETT in this patient population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Direct Laryngoscopy | Active Comparator | These patients will be nasally intubated for their procedure via direct laryngoscopy. We will observe and record incidence of Magill forcep use, presence or absence of nasal bleeding, and the grade of laryngeal view. We will also record any general narrative comments from the provider about the ease or difficulty of intubation. |
|
| Video Laryngoscopy | Experimental | These patients will undergo Video Laryngoscopy for nasal intubation. We will observe and record incidence of Magill forcep use, presence or absence of nasal bleeding, and the grade of laryngeal view. We will also record any general narrative comments from the provider about the ease or difficulty of intubation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Video Laryngoscopy for nasal intubation | Device | The anesthesia provider will use a video laryngoscope to facilitate the nasal intubation for the procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Requiring Use of Magill Forceps for Nasal Intubations | Reported as the number and percentage of participants that needed the use of Magill forceps during intubation | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Intubation | Reported as the average time it took to intubate (seconds). | 1 day |
| Grade of Larynx View | Larynx view is graded from 1-4 (1 is full glottis visible, 2 is only posterior commisure, 3 is only epiglottis visible, and 4 is no glottis structures are visible). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas W Templeton, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24958249 | Background | Sun Y, Lu Y, Huang Y, Jiang H. Pediatric video laryngoscope versus direct laryngoscope: a meta-analysis of randomized controlled trials. Paediatr Anaesth. 2014 Oct;24(10):1056-65. doi: 10.1111/pan.12458. Epub 2014 Jun 24. | |
| 21244568 | Result | Kim HJ, Kim JT, Kim HS, Kim CS, Kim SD. A comparison of GlideScope((R)) videolaryngoscopy and direct laryngoscopy for nasotracheal intubation in children. Paediatr Anaesth. 2011 Apr;21(4):417-21. doi: 10.1111/j.1460-9592.2010.03517.x. Epub 2011 Jan 19. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Direct Laryngoscopy | These patients will be nasally intubated for their procedure via direct laryngoscopy. We will observe and record incidence of Magill forcep use, presence or absence of nasal bleeding, and the grade of laryngeal view. We will also record any general narrative comments from the provider about the ease or difficulty of intubation. Direct Laryngoscopy: These patients will be nasally intubated for their procedure via direct laryngoscopy |
| FG001 | Video Laryngoscopy | These patients will undergo Video Laryngoscopy for nasal intubation. We will observe and record incidence of Magill forcep use, presence or absence of nasal bleeding, and the grade of laryngeal view. We will also record any general narrative comments from the provider about the ease or difficulty of intubation. Video Laryngoscopy for nasal intubation: The anesthesia provider will use a video laryngoscope to facilitate the nasal intubation for the procedure. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Direct Laryngoscopy | These patients will be nasally intubated for their procedure via direct laryngoscopy. We will observe and record incidence of Magill forcep use, presence or absence of nasal bleeding, and the grade of laryngeal view. We will also record any general narrative comments from the provider about the ease or difficulty of intubation. Direct Laryngoscopy: These patients will be nasally intubated for their procedure via direct laryngoscopy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants Requiring Use of Magill Forceps for Nasal Intubations | Reported as the number and percentage of participants that needed the use of Magill forceps during intubation | Posted | Count of Participants | Participants | 1 day |
|
1 day
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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 | Direct Laryngoscopy | These patients will be nasally intubated for their procedure via direct laryngoscopy. We will observe and record incidence of Magill forcep use, presence or absence of nasal bleeding, and the grade of laryngeal view. We will also record any general narrative comments from the provider about the ease or difficulty of intubation. Direct Laryngoscopy: These patients will be nasally intubated for their procedure via direct laryngoscopy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Thomas Templeton | Wake Forest University Health Sciences | 336-716-4285 | ttemplet@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 10, 2016 | Jul 10, 2018 | Prot_SAP_001.pdf |
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| Direct Laryngoscopy | Device | These patients will be nasally intubated for their procedure via direct laryngoscopy |
|
| 1 day |
| Presence of Nasal Bleeding | Number of participants that experienced nasal bleeding was recorded. | 1 day |
| Incidence of Failed Nasal Intubation | The incidence of failed nasal intubation was recorded as the number of intubations that were not successful. | 1 day |
| 18635480 | Result | Jones PM, Armstrong KP, Armstrong PM, Cherry RA, Harle CC, Hoogstra J, Turkstra TP. A comparison of glidescope videolaryngoscopy to direct laryngoscopy for nasotracheal intubation. Anesth Analg. 2008 Jul;107(1):144-8. doi: 10.1213/ane.0b013e31816d15c9. |
| BG001 | Video Laryngoscopy | These patients will undergo Video Laryngoscopy for nasal intubation. We will observe and record incidence of Magill forcep use, presence or absence of nasal bleeding, and the grade of laryngeal view. We will also record any general narrative comments from the provider about the ease or difficulty of intubation. Video Laryngoscopy for nasal intubation: The anesthesia provider will use a video laryngoscope to facilitate the nasal intubation for the procedure. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
These patients will undergo Video Laryngoscopy for nasal intubation. We will observe and record incidence of Magill forcep use, presence or absence of nasal bleeding, and the grade of laryngeal view. We will also record any general narrative comments from the provider about the ease or difficulty of intubation.
Video Laryngoscopy for nasal intubation: The anesthesia provider will use a video laryngoscope to facilitate the nasal intubation for the procedure.
|
|
| Secondary | Time to Intubation | Reported as the average time it took to intubate (seconds). | Posted | Mean | Standard Deviation | seconds | 1 day |
|
|
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| Secondary | Grade of Larynx View | Larynx view is graded from 1-4 (1 is full glottis visible, 2 is only posterior commisure, 3 is only epiglottis visible, and 4 is no glottis structures are visible). | Posted | Mean | Standard Deviation | units on a scale | 1 day |
|
|
|
| Secondary | Presence of Nasal Bleeding | Number of participants that experienced nasal bleeding was recorded. | Posted | Count of Participants | Participants | No | 1 day |
|
|
|
| Secondary | Incidence of Failed Nasal Intubation | The incidence of failed nasal intubation was recorded as the number of intubations that were not successful. | Posted | Number | number of intubations | 1 day |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Video Laryngoscopy | These patients will undergo Video Laryngoscopy for nasal intubation. We will observe and record incidence of Magill forcep use, presence or absence of nasal bleeding, and the grade of laryngeal view. We will also record any general narrative comments from the provider about the ease or difficulty of intubation. Video Laryngoscopy for nasal intubation: The anesthesia provider will use a video laryngoscope to facilitate the nasal intubation for the procedure. | 0 | 6 | 0 | 6 | 0 | 6 |
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