Trial Outcomes & Findings for Video vs. Direct Laryngoscopy in Pediatric Nasal Intubation (NCT NCT03032263)
NCT ID: NCT03032263
Last Updated: 2018-08-08
Results Overview
Reported as the number and percentage of participants that needed the use of Magill forceps during intubation
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
1 day
Results posted on
2018-08-08
Participant Flow
Participant milestones
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Video vs. Direct Laryngoscopy in Pediatric Nasal Intubation
Baseline characteristics by cohort
| Measure |
Direct Laryngoscopy
n=6 Participants
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
|
Video Laryngoscopy
n=6 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.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
6.33 years
STANDARD_DEVIATION 2.16 • n=5 Participants
|
7.33 years
STANDARD_DEVIATION 4.55 • n=7 Participants
|
6.83 years
STANDARD_DEVIATION 3.43 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 dayReported as the number and percentage of participants that needed the use of Magill forceps during intubation
Outcome measures
| Measure |
Direct Laryngoscopy
n=6 Participants
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
|
Video Laryngoscopy
n=6 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.
|
|---|---|---|
|
Number of Participants Requiring Use of Magill Forceps for Nasal Intubations
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 1 dayReported as the average time it took to intubate (seconds).
Outcome measures
| Measure |
Direct Laryngoscopy
n=6 Participants
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
|
Video Laryngoscopy
n=6 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.
|
|---|---|---|
|
Time to Intubation
|
68.43 seconds
Standard Deviation 81.1
|
57.1 seconds
Standard Deviation 25.12
|
SECONDARY outcome
Timeframe: 1 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).
Outcome measures
| Measure |
Direct Laryngoscopy
n=6 Participants
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
|
Video Laryngoscopy
n=6 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.
|
|---|---|---|
|
Grade of Larynx View
|
1.33 units on a scale
Standard Deviation .52
|
1 units on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 1 dayNumber of participants that experienced nasal bleeding was recorded.
Outcome measures
| Measure |
Direct Laryngoscopy
n=6 Participants
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
|
Video Laryngoscopy
n=6 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.
|
|---|---|---|
|
Presence of Nasal Bleeding
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 1 dayThe incidence of failed nasal intubation was recorded as the number of intubations that were not successful.
Outcome measures
| Measure |
Direct Laryngoscopy
n=6 Participants
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
|
Video Laryngoscopy
n=6 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.
|
|---|---|---|
|
Incidence of Failed Nasal Intubation
|
0 number of intubations
|
0 number of intubations
|
Adverse Events
Direct Laryngoscopy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Video Laryngoscopy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Thomas Templeton
Wake Forest University Health Sciences
Phone: 336-716-4285
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place