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The Effect of Paratracheal Pressure on the Glottic View

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03908411
Recruitment Status : Completed
First Posted : April 9, 2019
Last Update Posted : November 3, 2020
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE April 5, 2019
First Posted Date  ICMJE April 9, 2019
Last Update Posted Date November 3, 2020
Actual Study Start Date  ICMJE September 5, 2019
Actual Primary Completion Date February 25, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2019)
Cormack-Lehane grade [ Time Frame: During anesthesia induction procedure ]
Cormack-Lehane grade
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2019)
  • 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
  • Difficulty of mask ventilation [ Time Frame: During anesthesia induction procedure ]
    Difficulty of mask ventilation evaluated by the anesthesiologist (Easy/Moderate/Difficult/Impossible)
  • Inspiration pressure [ Time Frame: During anesthesia induction procedure ]
    Pressure to maintain adequated ventilation after application of the intervention
  • Tidal volume [ Time Frame: During anesthesia induction procedure ]
    Tidal volume which is achieved after application of the intervention
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2019)
  • POGO score (the percentage of glottic opening, 0-100%) [ Time Frame: During anesthesia induction procedure ]
    POGO score (the percentage of glottic opening, 0-100%)
  • Difficulty of mask ventilation [ Time Frame: During anesthesia induction procedure ]
    Difficulty of mask ventilation evaluated by the anesthesiologist (Easy/Moderate/Difficult/Impossible)
  • Inspiration pressure [ Time Frame: During anesthesia induction procedure ]
    Pressure to maintain adequated ventilation after application of the intervention
  • Tidal volume [ Time Frame: During anesthesia induction procedure ]
    Tidal volume which is achieved after application of the intervention
  • Intubation difficulty [ Time Frame: During anesthesia induction procedure ]
    Subjective evaluation of the difficulty to pass the endotracheal tube into the glottic opening
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Paratracheal Pressure on the Glottic View
Official Title  ICMJE The Effect of Paratracheal Pressure on the Glottic View During Direct Laryngoscopy : a Randomized Controlled Trial
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Paratracheal Pressure
  • Sellick's Maneuver
  • Airway Management
  • Cricoid Pressure
Intervention  ICMJE
  • Procedure: Paratracheal pressure
    Paratracheal pressure is applied by 30N force with the ultrasound transducer.
  • Procedure: Sellick's maneuver
    Conventional Sellick's maneuver is applied by 30N force
Study Arms  ICMJE
  • Active Comparator: Paratracheal pressure
    Left Paratracheal pressure is applied by ultrasound transducer after confirmation of the location of the esophagus.
    Intervention: Procedure: Paratracheal pressure
  • Active Comparator: Sellick's maneuver
    Conventional Sellick's maneuver is applied.
    Intervention: Procedure: Sellick's maneuver
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 8, 2019)
140
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 28, 2020
Actual Primary Completion Date February 25, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03908411
Other Study ID Numbers  ICMJE 10-2019-16
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Seoul National University Hospital
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP