The Effect of Paratracheal Pressure on the Glottic View
November 1, 2020 updated by: Seoul National University Hospital
The Effect of Paratracheal Pressure on the Glottic View During Direct Laryngoscopy : a Randomized Controlled Trial
Paratracheal pressure may have a role in the prevention of pulmonary aspiration.
The effects of paratracheal pressure on glottic view, ease of facemask ventilation, or tracheal intubation are not studied yet.
In this study, the subjects are divided into two groups (group I: paratracheal pressure applied during induction of anesthesia, group II: conventional Sellick's maneuver applied during induction of anesthesia).
Investigators will assess the glottic view during direct laryngoscopy.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Primary outcome:
-Cormack-Lehane grade
Secondary outcome:
- POGO score before and after application of each intervention
- Difficulties of mask ventilation after application of each intervention
- Inspiratory pressure and tidal volume during manual mask ventilation
- Rates of worsening of the glottic view after intervention
- The difficulty of endotracheal intubation
- Intubation time
Study Type
Interventional
Enrollment (Actual)
140
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, 07061
- SMG - SNU Boramae Medical Center
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Seoul, Korea, Republic of, 07061
- Seoul National University Hospital
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-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
Adult patient undergoing elective surgery with general anesthesia
Exclusion Criteria:
A patient who does not agree to participate in this study A patient who has a history of cervical/esophageal operation A patient who has a risk of gastric regurgitation A patient who has atherosclerosis of the left carotid artery or history of stroke or angina in 3 months.
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Paratracheal pressure
Left Paratracheal pressure is applied by ultrasound transducer after confirmation of the location of the esophagus.
|
Paratracheal pressure is applied by 30N force with the ultrasound transducer.
|
|
Active Comparator: Sellick's maneuver
Conventional Sellick's maneuver is applied.
|
Conventional Sellick's maneuver is applied by 30N force
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cormack-Lehane grade
Time Frame: During anesthesia induction procedure
|
Cormack-Lehane grade
|
During anesthesia induction procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
POGO
Time Frame: During anesthesia induction procedure
|
The percentage of glottic opening (POGO), linear span from the anterior commissure to the interarytenoid notch, 0-100%, higher value represent a better view
|
During anesthesia induction procedure
|
|
Difficulty of mask ventilation
Time Frame: During anesthesia induction procedure
|
Difficulty of mask ventilation evaluated by the anesthesiologist (Easy/Moderate/Difficult/Impossible)
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During anesthesia induction procedure
|
|
Inspiration pressure
Time Frame: During anesthesia induction procedure
|
Pressure to maintain adequated ventilation after application of the intervention
|
During anesthesia induction procedure
|
|
Tidal volume
Time Frame: During anesthesia induction procedure
|
Tidal volume which is achieved after application of the intervention
|
During anesthesia induction procedure
|
|
Intubation difficulty
Time Frame: During anesthesia induction procedure
|
Subjective evaluation of the difficulty to pass the endotracheal tube into the glottic opening, easy/moderate/difficult
|
During anesthesia induction procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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)
September 5, 2019
Primary Completion (Actual)
February 25, 2020
Study Completion (Actual)
February 28, 2020
Study Registration Dates
First Submitted
April 5, 2019
First Submitted That Met QC Criteria
April 8, 2019
First Posted (Actual)
April 9, 2019
Study Record Updates
Last Update Posted (Actual)
November 3, 2020
Last Update Submitted That Met QC Criteria
November 1, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 10-2019-16
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.