Skip to content

Video vs. Direct Laryngoscopy in Pediatric Nasal Intubation

A Comparison of Direct Laryngoscopy and Video Laryngoscopy Using the C-Mac in Pediatric Nasal Intubations

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03032263
Enrollment
12
Registered
2017-01-26
Start date
2016-03-31
Completion date
2017-08-07
Last updated
2018-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasal Intubation

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

DEVICEVideo Laryngoscopy for nasal intubation

The anesthesia provider will use a video laryngoscope to facilitate the nasal intubation for the procedure.

DEVICEDirect Laryngoscopy

These patients will be nasally intubated for their procedure via direct laryngoscopy

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Years to 14 Years
Healthy volunteers
Yes

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

MeasureTime frameDescription
Number of Participants Requiring Use of Magill Forceps for Nasal Intubations1 dayReported as the number and percentage of participants that needed the use of Magill forceps during intubation

Secondary

MeasureTime frameDescription
Time to Intubation1 dayReported as the average time it took to intubate (seconds).
Grade of Larynx View1 dayLarynx 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 Bleeding1 dayNumber of participants that experienced nasal bleeding was recorded.
Incidence of Failed Nasal Intubation1 dayThe incidence of failed nasal intubation was recorded as the number of intubations that were not successful.

Countries

United States

Participant flow

Participants by arm

ArmCount
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
Total12

Baseline characteristics

CharacteristicDirect LaryngoscopyVideo LaryngoscopyTotal
Age, Continuous6.33 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 Participants0 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
5 Participants6 Participants11 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Sex: Female, Male
Female
3 Participants2 Participants5 Participants
Sex: Female, Male
Male
3 Participants4 Participants7 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 60 / 6
other
Total, other adverse events
0 / 60 / 6
serious
Total, serious adverse events
0 / 60 / 6

Outcome results

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

Time frame: 1 day

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Direct LaryngoscopyNumber of Participants Requiring Use of Magill Forceps for Nasal Intubations1 Participants
Video LaryngoscopyNumber of Participants Requiring Use of Magill Forceps for Nasal Intubations2 Participants
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).

Time frame: 1 day

ArmMeasureValue (MEAN)Dispersion
Direct LaryngoscopyGrade of Larynx View1.33 units on a scaleStandard Deviation 0.52
Video LaryngoscopyGrade of Larynx View1 units on a scaleStandard Deviation 0
Secondary

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

ArmMeasureValue (NUMBER)
Direct LaryngoscopyIncidence of Failed Nasal Intubation0 number of intubations
Video LaryngoscopyIncidence of Failed Nasal Intubation0 number of intubations
Secondary

Presence of Nasal Bleeding

Number of participants that experienced nasal bleeding was recorded.

Time frame: 1 day

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Direct LaryngoscopyPresence of Nasal Bleeding3 Participants
Video LaryngoscopyPresence of Nasal Bleeding3 Participants
Secondary

Time to Intubation

Reported as the average time it took to intubate (seconds).

Time frame: 1 day

ArmMeasureValue (MEAN)Dispersion
Direct LaryngoscopyTime to Intubation68.43 secondsStandard Deviation 81.1
Video LaryngoscopyTime to Intubation57.1 secondsStandard Deviation 25.12

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026