Clinical Trials Logo

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


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
See also
  Status Clinical Trial Phase
Completed NCT04564105 - Simulation Training and Teamwork Concerning Intubation on the Icu N/A
Completed NCT02988336 - TMHT - New Method of Difficult Intubation Prediction N/A
Completed NCT03002857 - Comparison of I-gel LMA, Classical LMA With a New Supraglottic Airway the Baska Mask® in Urological Surgery N/A
Recruiting NCT06337006 - Laryngeal Mask Airway Failure in Pediatric Patients
Completed NCT03443219 - RCT- LMA Supremeā„¢ Versus the Spritztube® Tracheal Cannula in Anesthetized Adult Patients N/A
Completed NCT05044416 - VieScope in Patients With an Expected Difficult Airway N/A
Not yet recruiting NCT05534451 - Comparison Among Three Different Video Scope Guided Nasotracheal Intubation. N/A
Recruiting NCT06073977 - Risk Factors for Pediatric Difficult Supraglottic Airway Placement and Ventilation
Not yet recruiting NCT03687424 - Can High-flow Nasal Oxygenation Improve Oxygen Saturation During Analgo-sedation in Obese Adults? N/A
Not yet recruiting NCT03687385 - The Effect of High-flow Nasal Oxygenation to the Saturation During Analgo-sedation in Different ASA Risk Class Patients N/A
Enrolling by invitation NCT05055401 - Airway Management Skills Amongst Anesthesia Providers
Terminated NCT02644837 - AuraGain and iGel Crossover Comparison N/A
Not yet recruiting NCT02920879 - Airway Effects of PEEP During Anesthesia Induction. N/A
Completed NCT02263300 - Spatial Orientation and Fiberoptic Intubation Skills in the Novice: A Randomized Controlled Trial
Completed NCT01718561 - The Difficult Airway Management Trial: "The DIFFICAIR-Trial" N/A
Completed NCT01635660 - Out-of-Hospital Randomized Comparison of Video-assisted Endotracheal Intubation N/A
Completed NCT00956592 - Clinical Evaluation of the Storz CMAC Laryngoscope N/A
Completed NCT00892671 - Airway Management and Vascular Access Simulation N/A
Completed NCT03848559 - Airway Management With Simulated Microgravity Using a Submerged Model N/A
Completed NCT05160207 - Intubation-induced Decrease in Heart Rate as an Indicator for Intraoperative Bradycardia