- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02828631
A Comparison of McGrath, Pentax and Macintosh Laryngoscopes for Nasotracheal Intubation in Pediatrics
January 8, 2019 updated by: yun jeong chae, Ajou University School of Medicine
Videolaryngoscope provide better view of the larynx.
This better view could improve the navigation of endotracheal tube in nasotracheal intubation.
Contrast to the improved result in adult, one previous report using Glidescope in children did not show better performance than direct laryngoscope.
The aim of this study is to compare the performance of McGrath, Pentax and Macintosh laryngoscope for nasotracheal intubation in children.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
108
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gyeong-gi Do
-
Suwon-si, Gyeong-gi Do, Korea, Republic of, 16499
- Ajou universitiy school of medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 10 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- American Society of Anesthesiologist physical status class I, II
Exclusion Criteria:
- abnormality of airway
- bleeding tendency
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Macintosh laryngoscope
Nasotracheal intubation by Macintosh laryngoscope
|
|
Experimental: McGrath videolaryngoscope
Nasotracheal intubation by McGrath videolaryngoscope
|
|
Experimental: Pentax videolaryngoscope
Nasotracheal intubation by Pentax videolaryngoscope
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
time to intubation
Time Frame: 2 min
|
Time from nasotracheal tube passing nose until confirmation of tracheal intubation by end-tidal carbon dioxide will be measured
|
2 min
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
intubation difficulty scale
Time Frame: immediately after intubation
|
Modified nasal intubation difficulty scale will be assessed : N1(intubation attempts), N2(operators to attempt intubation, N3(alternative intubation techniques or change head position), N4(glottic exposure), N5(lifting force required to expose the vocal cords), N6(optimise glottic exposure with backward, upward and right ward pressure), N7(techniques to aid intubation)
|
immediately after intubation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2016
Primary Completion (Actual)
October 1, 2017
Study Completion (Actual)
October 1, 2017
Study Registration Dates
First Submitted
June 30, 2016
First Submitted That Met QC Criteria
July 7, 2016
First Posted (Estimate)
July 11, 2016
Study Record Updates
Last Update Posted (Actual)
January 10, 2019
Last Update Submitted That Met QC Criteria
January 8, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- AJIRB-MED-OBS-16-145
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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