NCT03558633

Brief Summary

Comparing the effects of ' Cricoid pressure' or 'Paralaryngeal pressure' during endotracheal intubation procedure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 15, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2019

Completed
Last Updated

August 16, 2019

Status Verified

August 1, 2019

Enrollment Period

1 year

First QC Date

April 26, 2018

Last Update Submit

August 13, 2019

Conditions

Keywords

Cricoid pressureParalaryngeal pressureIntubation

Outcome Measures

Primary Outcomes (1)

  • Occlusion of esophagus

    Occlusion of esophagus is checked under the application of cricoid and paralaryngeal pressures during direct laryngsocpy

    for 1 minute during direct laryngosopy

Secondary Outcomes (3)

  • The relative position of the upper esophageal end to the glottis

    1 minute before and after the induction of anesthesia, during direct laryngoscopy

  • The outer anteroposterior diameter of the upper esophageal end

    During 1 minute in awake and anesthetized paralyzed states

  • POGO score

    during direct laryngoscopy

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Who has any surgery under general anesthesia and agree with the purpose of the study

You may qualify if:

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

You may not qualify if:

  • Diseases or anatomical abnormalities in the neck, larynx, pharynx or esophagus,
  • Aspiration tendency
  • Known or predicted difficult airway.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, 156-707, South Korea

Location

Related Publications (3)

  • Warner MA, Warner ME, Weber JG. Clinical significance of pulmonary aspiration during the perioperative period. Anesthesiology. 1993 Jan;78(1):56-62. doi: 10.1097/00000542-199301000-00010.

    PMID: 8424572BACKGROUND
  • Lienhart A, Auroy Y, Pequignot F, Benhamou D, Warszawski J, Bovet M, Jougla E. Survey of anesthesia-related mortality in France. Anesthesiology. 2006 Dec;105(6):1087-97. doi: 10.1097/00000542-200612000-00008.

    PMID: 17122571BACKGROUND
  • Koenig SJ, Lakticova V, Mayo PH. Utility of ultrasonography for detection of gastric fluid during urgent endotracheal intubation. Intensive Care Med. 2011 Apr;37(4):627-31. doi: 10.1007/s00134-010-2125-9. Epub 2011 Feb 2.

    PMID: 21287147BACKGROUND

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, Department of Anesthesiology and Pain medicine

Study Record Dates

First Submitted

April 26, 2018

First Posted

June 15, 2018

Study Start

June 1, 2018

Primary Completion

June 5, 2019

Study Completion

June 5, 2019

Last Updated

August 16, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations