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Video vs. Direct Laryngoscopy in Pediatric Nasal Intubation

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ClinicalTrials.gov Identifier: NCT03032263
Recruitment Status : Terminated (Not enough participants enrolled)
First Posted : January 26, 2017
Results First Posted : July 11, 2018
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Condition Nasal Intubation
Interventions Device: Video Laryngoscopy for nasal intubation
Device: Direct Laryngoscopy
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Direct Laryngoscopy Video Laryngoscopy
Hide Arm/Group Description

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

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.

Period Title: Overall Study
Started 6 6
Completed 6 6
Not Completed 0 0
Arm/Group Title Direct Laryngoscopy Video Laryngoscopy Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 6 6 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 12 participants
6.33  (2.16) 7.33  (4.55) 6.83  (3.43)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Female
3
  50.0%
2
  33.3%
5
  41.7%
Male
3
  50.0%
4
  66.7%
7
  58.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Hispanic or Latino
1
  16.7%
0
   0.0%
1
   8.3%
Not Hispanic or Latino
5
  83.3%
6
 100.0%
11
  91.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Participants Requiring Use of Magill Forceps for Nasal Intubations
Hide Description Reported as the number and percentage of participants that needed the use of Magill forceps during intubation
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Direct Laryngoscopy Video Laryngoscopy
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
1
  16.7%
2
  33.3%
2.Secondary Outcome
Title Time to Intubation
Hide Description Reported as the average time it took to intubate (seconds).
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Direct Laryngoscopy Video Laryngoscopy
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: seconds
68.43  (81.1) 57.1  (25.12)
3.Secondary Outcome
Title Grade of Larynx View
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Direct Laryngoscopy Video Laryngoscopy
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.33  (.52) 1  (0)
4.Secondary Outcome
Title Presence of Nasal Bleeding
Hide Description Number of participants that experienced nasal bleeding was recorded.
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Direct Laryngoscopy Video Laryngoscopy
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
3 3
5.Secondary Outcome
Title Incidence of Failed Nasal Intubation
Hide Description The incidence of failed nasal intubation was recorded as the number of intubations that were not successful.
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Direct Laryngoscopy Video Laryngoscopy
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 6 6
Measure Type: Number
Unit of Measure: number of intubations
0 0
Time Frame 1 day
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Direct Laryngoscopy Video Laryngoscopy
Hide Arm/Group Description

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

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.

All-Cause Mortality
Direct Laryngoscopy Video Laryngoscopy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/6 (0.00%) 
Hide Serious Adverse Events
Direct Laryngoscopy Video Laryngoscopy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/6 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Direct Laryngoscopy Video Laryngoscopy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/6 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Thomas Templeton
Organization: Wake Forest University Health Sciences
Phone: 336-716-4285
EMail: ttemplet@wakehealth.edu
Layout table for additonal information
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03032263    
Other Study ID Numbers: CMac-032016
First Submitted: January 12, 2017
First Posted: January 26, 2017
Results First Submitted: June 14, 2018
Results First Posted: July 11, 2018
Last Update Posted: August 8, 2018