An interventional study of Video Laryngoscopy for nasal intubation and Direct Laryngoscopy in Nasal Intubation, sponsored by Wake Forest University Health Sciences. Terminated at 1 site in United States. Open to participants aged 3 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-08.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Health services research
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.
Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: Direct 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.
Device: Video Laryngoscopy for nasal intubation
The anesthesia provider will use a video laryngoscope to facilitate the nasal intubation for the procedure.
These patients will be nasally intubated for their procedure via direct laryngoscopy
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
Time frame: 1 day
Time to Intubation
Reported as the average time it took to intubate (seconds).
Time frame: 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).
Time frame: 1 day
Presence of Nasal Bleeding
Number of participants that experienced nasal bleeding was recorded.
Time frame: 1 day
Incidence of Failed Nasal Intubation
The incidence of failed nasal intubation was recorded as the number of intubations that were not successful.
Time frame: 1 day
| Milestone | Direct Laryngoscopy | Video Laryngoscopy |
|---|---|---|
| Started | 6 | 6 |
| Completed | 6 | 6 |
| Not completed | 0 | 0 |
Reported as the number and percentage of participants that needed the use of Magill forceps during intubation
| Participants | Direct Laryngoscopy | Video Laryngoscopy |
|---|---|---|
| Number of Participants Requiring Use of Magill Forceps for Nasal Intubations | 1 | 2 |
Reported as the average time it took to intubate (seconds).
| seconds | Direct Laryngoscopy | Video Laryngoscopy |
|---|---|---|
| Time to Intubation | 68.43 ± 81.1 | 57.1 ± 25.12 |
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).
| units on a scale | Direct Laryngoscopy | Video Laryngoscopy |
|---|---|---|
| Grade of Larynx View | 1.33 ± .52 | 1 ± 0 |
Number of participants that experienced nasal bleeding was recorded.
| Participants | Direct Laryngoscopy | Video Laryngoscopy |
|---|---|---|
| Presence of Nasal Bleeding | 3 | 3 |
The incidence of failed nasal intubation was recorded as the number of intubations that were not successful.
| number of intubations | Direct Laryngoscopy | Video Laryngoscopy |
|---|---|---|
| Incidence of Failed Nasal Intubation | 0 | 0 |
Collected over 1 day. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Direct Laryngoscopy | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Video Laryngoscopy | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Age, Continuous(years) | Direct Laryngoscopy | Video Laryngoscopy | Total |
|---|---|---|---|
| Mean | 6.33 ± 2.16 | 7.33 ± 4.55 | 6.83 ± 3.43 |
| Sex: Female, Male(Participants) | Direct Laryngoscopy | Video Laryngoscopy | Total |
|---|---|---|---|
| Female | 3 | 2 | 5 |
| Male | 3 | 4 | 7 |
| Ethnicity (NIH/OMB)(Participants) | Direct Laryngoscopy | Video Laryngoscopy | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 5 | 6 | 11 |
| Unknown or Not Reported | 0 | 0 | 0 |
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Wake Forest University Health Sciences