- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05128968
Head and Neck Positions for Endotracheal Intubation Using a Videolaryngoscope
December 28, 2022 updated by: Jin-Young Hwang, SMG-SNU Boramae Medical Center
Impact of Head and Neck Positions on Endotracheal Intubation Using a McGRATH MAC Video Laryngoscope
In this study, the investigators evaluate the effect of head positions (simple extension vs. sniffing position vs. head elevation) on endotracheal intubation using a videolaryngoscope.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
174
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
-
-
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Seoul, Korea, Republic of, 156-707
- Seoul Metropolitan Government Seoul National University Boramae Medical Center
-
-
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
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients scheduled for general anesthesia
Exclusion Criteria:
- Limited neck extension
- Anatomical anomalies or history of surgery in the upper airway
- Weak teeth
- Risk of pulmonary aspiration
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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Simple extension
After induction of anesthesia, endotracheal intubation was performed in simple extension without a pillow using a McGrath MAC videolaryngoscope.
|
Endotracheal intubation is performed in simple head extension or sniffing position using a McGrath MAC videolaryngoscope.
|
|
Experimental: Head elevated position
After induction of anesthesia, endotracheal intubation was performed in a head elevated position with a pillow using a McGrath MAC videolaryngoscope.
|
Endotracheal intubation is performed in simple head extension or sniffing position using a McGrath MAC videolaryngoscope.
|
|
Experimental: Sniffing position
After induction of anesthesia, endotracheal intubation was performed in a sniffing position using a McGrath MAC videolaryngoscope.
|
Endotracheal intubation is performed in simple head extension or sniffing position using a McGrath MAC videolaryngoscope.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ease of intubation
Time Frame: Procedure (During endotracheal intubation)
|
Ease of endotracheal intubation is assessed using the intubation difficulty scale. Intubation difficulty scale includes number of attempts, number of operators, number of alternative techniques, glottic opening and so on. |
Procedure (During endotracheal intubation)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of glottic opening (POGO) score
Time Frame: Procedure (During endotracheal intubation)
|
POGO score is recorded during endotracheal intubation (0%: no visualization of glottic opening; 100%: entire visualization of the glottic opening).
|
Procedure (During endotracheal intubation)
|
|
Number of attempts
Time Frame: Procedure (At the end of endotracheal intubation)
|
Number of attempts for endotracheal intubation is recorded.
|
Procedure (At the end of endotracheal intubation)
|
|
Intubation time
Time Frame: Procedure (During endotracheal intubation)
|
The time taken for endotracheal intubation is recorded.
|
Procedure (During endotracheal intubation)
|
|
Palatopharyngeal wall injury
Time Frame: Procedure (During endotracheal intubation)
|
Presence of palatopharyngeal wall injury is observed.
|
Procedure (During endotracheal intubation)
|
|
Lifting force for exposure of the glottis
Time Frame: Procedure (During endotracheal intubation)
|
Requirement for lifting force to expose the glottis is recorded during videolaryngoscopy
|
Procedure (During endotracheal intubation)
|
|
Laryngeal pressure for exposure of the glottis
Time Frame: Procedure (During endotracheal intubation)
|
Requirement for laryngeal force to expose the glottis is recorded during videolaryngoscopy
|
Procedure (During endotracheal intubation)
|
|
Lifting force for advancing an endotracheal tube into the larynx
Time Frame: Procedure (During endotracheal intubation)
|
Requirement for lifting force is recorded during the advancement of the endotracheal tube into the larynx.
|
Procedure (During endotracheal intubation)
|
|
Laryngeal pressure for advancing an endotracheal tube into the larynx.
Time Frame: Procedure (During endotracheal intubation)
|
Requirement for laryngeal pressure is recorded during the advancement of the endotracheal tube into the larynx.
|
Procedure (During endotracheal intubation)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jin-Young Hwang, PhD., SMG-SNU Boramae Medical Center
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)
December 1, 2021
Primary Completion (Actual)
December 9, 2022
Study Completion (Actual)
December 9, 2022
Study Registration Dates
First Submitted
November 11, 2021
First Submitted That Met QC Criteria
November 19, 2021
First Posted (Actual)
November 22, 2021
Study Record Updates
Last Update Posted (Estimate)
December 29, 2022
Last Update Submitted That Met QC Criteria
December 28, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 11-2021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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