Nasal Intubation
Conditions
Brief summary
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.
Detailed description
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.
Interventions
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
Sponsors
Study design
Eligibility
Inclusion criteria
* Patients between the ages of 3 and 14 scheduled for comprehensive dental treatment under general anesthesia * Normal appearing airway upon pre-operative assessment
Exclusion criteria
* Patient with a history of difficult airway/intubation * Patients suspected to have a difficult airway * History of cleft palate and/or cleft palate repair * Pregnancy * Emergency status of surgery * Any patient with a contra-indication to nasal tube placement * Any patient with a potentially increased risk of nasal bleeding from nasal placement of the ETT i.e. patients on aspirin or other anticoagulants, patient's with hemophilia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Requiring Use of Magill Forceps for Nasal Intubations | 1 day | Reported as the number and percentage of participants that needed the use of Magill forceps during intubation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Intubation | 1 day | Reported as the average time it took to intubate (seconds). |
| Grade of Larynx View | 1 day | 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). |
| Presence of Nasal Bleeding | 1 day | Number of participants that experienced nasal bleeding was recorded. |
| Incidence of Failed Nasal Intubation | 1 day | The incidence of failed nasal intubation was recorded as the number of intubations that were not successful. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 6 |
| 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. | 6 |
| Total | 12 |
Baseline characteristics
| Characteristic | Direct Laryngoscopy | Video Laryngoscopy | Total |
|---|---|---|---|
| Age, Continuous | 6.33 years STANDARD_DEVIATION 2.16 | 7.33 years STANDARD_DEVIATION 4.55 | 6.83 years STANDARD_DEVIATION 3.43 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 6 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Direct Laryngoscopy | Number of Participants Requiring Use of Magill Forceps for Nasal Intubations | 1 Participants |
| Video Laryngoscopy | Number of Participants Requiring Use of Magill Forceps for Nasal Intubations | 2 Participants |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Direct Laryngoscopy | Grade of Larynx View | 1.33 units on a scale | Standard Deviation 0.52 |
| Video Laryngoscopy | Grade of Larynx View | 1 units on a scale | Standard Deviation 0 |
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Direct Laryngoscopy | Incidence of Failed Nasal Intubation | 0 number of intubations |
| Video Laryngoscopy | Incidence of Failed Nasal Intubation | 0 number of intubations |
Presence of Nasal Bleeding
Number of participants that experienced nasal bleeding was recorded.
Time frame: 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Direct Laryngoscopy | Presence of Nasal Bleeding | 3 Participants |
| Video Laryngoscopy | Presence of Nasal Bleeding | 3 Participants |
Time to Intubation
Reported as the average time it took to intubate (seconds).
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Direct Laryngoscopy | Time to Intubation | 68.43 seconds | Standard Deviation 81.1 |
| Video Laryngoscopy | Time to Intubation | 57.1 seconds | Standard Deviation 25.12 |