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NCT03908411 Clinical Trial

The Effect of Paratracheal Pressure on the Glottic View

Airway Management Clinical Trial

Official title:
The Effect of Paratracheal Pressure on the Glottic View During Direct Laryngoscopy : a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03908411
Other study ID # 10-2019-16
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 5, 2019
Est. completion date February 28, 2020

Study information
Verified date October 2020
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Completed
Enrollment 140
Est. completion date February 28, 2020
Est. primary completion date February 25, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Paratracheal pressure
Paratracheal pressure is applied by 30N force with the ultrasound transducer.
• Sellick's maneuver
Conventional Sellick's maneuver is applied by 30N force

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of SMG - SNU Boramae Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cormack-Lehane grade Cormack-Lehane grade During anesthesia induction procedure
Secondary POGO 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
Secondary Difficulty of mask ventilation Difficulty of mask ventilation evaluated by the anesthesiologist (Easy/Moderate/Difficult/Impossible) During anesthesia induction procedure
Secondary Inspiration pressure Pressure to maintain adequated ventilation after application of the intervention During anesthesia induction procedure
Secondary Tidal volume Tidal volume which is achieved after application of the intervention During anesthesia induction procedure
Secondary Intubation difficulty Subjective evaluation of the difficulty to pass the endotracheal tube into the glottic opening, easy/moderate/difficult During anesthesia induction procedure
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