The Effect of Paratracheal Pressure on the Glottic View
1 other identifier
interventional
140
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2019
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 5, 2019
CompletedFirst Posted
Study publicly available on registry
April 9, 2019
CompletedStudy Start
First participant enrolled
September 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 25, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2020
CompletedNovember 3, 2020
October 1, 2020
6 months
April 5, 2019
November 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cormack-Lehane grade
Cormack-Lehane grade
During anesthesia induction procedure
Secondary Outcomes (5)
POGO
During anesthesia induction procedure
Difficulty of mask ventilation
During anesthesia induction procedure
Inspiration pressure
During anesthesia induction procedure
Tidal volume
During anesthesia induction procedure
Intubation difficulty
During anesthesia induction procedure
Study Arms (2)
Paratracheal pressure
ACTIVE COMPARATORLeft Paratracheal pressure is applied by ultrasound transducer after confirmation of the location of the esophagus.
Sellick's maneuver
ACTIVE COMPARATORConventional Sellick's maneuver is applied.
Interventions
Paratracheal pressure is applied by 30N force with the ultrasound transducer.
Conventional Sellick's maneuver is applied by 30N force
Eligibility Criteria
You may qualify if:
- Adult patient undergoing elective surgery with general anesthesia
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Seoul National University Hospital
Seoul, 07061, South Korea
SMG - SNU Boramae Medical Center
Seoul, 07061, South Korea
Related Publications (1)
Won D, Kim H, Chang JE, Lee JM, Min SW, Ma S, Kim C, Hwang JY, Kim TK. Effect of Paratracheal Pressure on the Glottic View During Direct Laryngoscopy: A Randomized Double-Blind, Noninferiority Trial. Anesth Analg. 2021 Aug 1;133(2):491-499. doi: 10.1213/ANE.0000000000005620.
PMID: 34081034DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2019
First Posted
April 9, 2019
Study Start
September 5, 2019
Primary Completion
February 25, 2020
Study Completion
February 28, 2020
Last Updated
November 3, 2020
Record last verified: 2020-10