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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Paratracheal Pressure Sellick's Maneuver Airway Management Cricoid Pressure Procedure: Paratracheal pressure Procedure: Sellick's maneuver Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Paratracheal Pressure on the Glottic View During Direct Laryngoscopy : a Randomized Controlled Trial
Actual Study Start Date : September 5, 2019
Actual Primary Completion Date : February 25, 2020
Actual Study Completion Date : February 28, 2020
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Paratracheal pressure
Left Paratracheal pressure is applied by ultrasound transducer after confirmation of the location of the esophagus.
 Procedure: Paratracheal pressure
Paratracheal pressure is applied by 30N force with the ultrasound transducer.
Active Comparator: Sellick's maneuver
Conventional Sellick's maneuver is applied.
 Procedure: Sellick's maneuver
Conventional Sellick's maneuver is applied by 30N force


Outcome Measures
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Primary Outcome Measures :
  1. Cormack-Lehane grade [ Time Frame: During anesthesia induction procedure ]
    Cormack-Lehane grade


Secondary Outcome Measures :
  1. 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

  2. Difficulty of mask ventilation [ Time Frame: During anesthesia induction procedure ]
    Difficulty of mask ventilation evaluated by the anesthesiologist (Easy/Moderate/Difficult/Impossible)

  3. Inspiration pressure [ Time Frame: During anesthesia induction procedure ]
    Pressure to maintain adequated ventilation after application of the intervention

  4. Tidal volume [ Time Frame: During anesthesia induction procedure ]
    Tidal volume which is achieved after application of the intervention

  5. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03908411


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 07061
SMG - SNU Boramae Medical Center
Seoul, Korea, Republic of, 07061
Sponsors and Collaborators
Seoul National University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03908411    
Other Study ID Numbers: 10-2019-16
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seoul National University Hospital:
Paratracheal pressure