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出境医 / 临床实验 / Effectiveness of Cricoid and Paratracheal Pressures for Occluding Esophagus

Effectiveness of Cricoid and Paratracheal Pressures for Occluding Esophagus

Study Description
Brief Summary:
Comparing the effects of 'Cricoid pressure' or 'Paratracheal pressure' during direct laryngoscopy

Condition or disease Intervention/treatment Phase
Intubation Complication Other: Maneuvers for occluding esophagus Not Applicable

Detailed Description:
The effectiveness of cricoid pressure and paratracheal pressure for occluding esophagus during direct and video laryngoscopies.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effectiveness of Cricoid and Paratracheal Pressures for Occluding Esophagus in Anesthetized and Paralyzed Patients During Direct and Video Laryngoscopies
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : July 30, 2020
Estimated Study Completion Date : July 30, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Cricoid pressure
Cricoid pressure is applied during direct and video laryngoscopies
 Other: Maneuvers for occluding esophagus
Cricoid pressure: pressure on the cricoid ring Paratracheal pressure: pressure on the left paratracheal region below the cricoid level
Experimental: Paratracheal pressure
Cricoid pressure is applied during direct and video laryngoscopies
 Other: Maneuvers for occluding esophagus
Cricoid pressure: pressure on the cricoid ring Paratracheal pressure: pressure on the left paratracheal region below the cricoid level
Outcome Measures
Primary Outcome Measures :
  1. Occlusion of esophagus [ Time Frame: during 2 min under direct and video laryngoscopies ]
    Occlusion of esophagus is checked with the application of cricoid and paratracehal pressures using esophageal stethoscope.


Secondary Outcome Measures :
  1. Occlusion of esophagus between direct and video laryngoscopies [ Time Frame: procedure (under direct and video laryngoscopies) ]
    Occlusion of esophagus is checked under the application of cricoid and paratracheal pressures between direct and video laryngoscopies

  2. POGO score [ Time Frame: procedure (during direct laryngoscopy) ]
    POGO score under the application of cricoid and paratracheal pressures


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Who would be scheduled any surgery under general anesthesia and agree with the purpose of the study

Exclusion Criteria:

  • Risk of aspiration Limited neck extension Facial and upper airway anomalies History of esophageal surgery, esophagus abnormalities
Contacts and Locations

No Contacts or Locations Provided

Tracking Information
First Submitted Date  ICMJE June 19, 2019
First Posted Date  ICMJE June 20, 2019
Last Update Posted Date June 20, 2019
Estimated Study Start Date  ICMJE August 1, 2019
Estimated Primary Completion Date July 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2019) 		Occlusion of esophagus [ Time Frame: during 2 min under direct and video laryngoscopies ]
Occlusion of esophagus is checked with the application of cricoid and paratracehal pressures using esophageal stethoscope.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2019)
  • Occlusion of esophagus between direct and video laryngoscopies [ Time Frame: procedure (under direct and video laryngoscopies) ]
    Occlusion of esophagus is checked under the application of cricoid and paratracheal pressures between direct and video laryngoscopies
  • POGO score [ Time Frame: procedure (during direct laryngoscopy) ]
    POGO score under the application of cricoid and paratracheal pressures
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Cricoid and Paratracheal Pressures for Occluding Esophagus
Official Title  ICMJE Effectiveness of Cricoid and Paratracheal Pressures for Occluding Esophagus in Anesthetized and Paralyzed Patients During Direct and Video Laryngoscopies
Brief Summary Comparing the effects of 'Cricoid pressure' or 'Paratracheal pressure' during direct laryngoscopy
Detailed Description The effectiveness of cricoid pressure and paratracheal pressure for occluding esophagus during direct and video laryngoscopies.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Intubation Complication
Intervention  ICMJE Other: Maneuvers for occluding esophagus
Cricoid pressure: pressure on the cricoid ring Paratracheal pressure: pressure on the left paratracheal region below the cricoid level
Study Arms  ICMJE
  • Experimental: Cricoid pressure
    Cricoid pressure is applied during direct and video laryngoscopies
    Intervention: Other: Maneuvers for occluding esophagus
  • Experimental: Paratracheal pressure
    Cricoid pressure is applied during direct and video laryngoscopies
    Intervention: Other: Maneuvers for occluding esophagus
Publications * Not Provided

*   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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 19, 2019) 		120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 30, 2020
Estimated Primary Completion Date July 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Who would be scheduled any surgery under general anesthesia and agree with the purpose of the study

Exclusion Criteria:

  • Risk of aspiration Limited neck extension Facial and upper airway anomalies History of esophageal surgery, esophagus abnormalities
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03992950
Other Study ID Numbers  ICMJE P2019-195
Has Data Monitoring Committee No
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 Jin-Young Hwang, SMG-SNU Boramae Medical Center
Study Sponsor  ICMJE SMG-SNU Boramae Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account SMG-SNU Boramae Medical Center
Verification Date June 2019

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

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