NCT03375554

Brief Summary

The goal of this prospective observational study is to investigate the effect on esophageal stethoscope insertion on tracheal cuff pressure during general anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 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

December 13, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 18, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

April 4, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2018

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2018

Completed
Last Updated

August 18, 2020

Status Verified

August 1, 2020

Enrollment Period

2 months

First QC Date

December 13, 2017

Last Update Submit

August 14, 2020

Conditions

Intubation Complication

Keywords

esophageal steothoscope, tracheal intubation

Outcome Measures

Primary Outcomes (1)

  • Change of cuff pressure

    Change of cuff pressure by inserting of esophageal stethoscope, compared with before insertion of it

    intraoperative

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient receiving general anesthesia for elective surgery

You may qualify if:

  • Patient receiving general anesthesia for elective surgery

You may not qualify if:

  • who doesn't agree to enroll
  • who has any clinical disease or history of surgery in esophagus
  • who has aspiration tendency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, 07061, South Korea

Location

Study Officials

  • Jung-Man Lee, M.D.,PhD

    SMG-SNU Boramae Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical assistant professor

Study Record Dates

First Submitted

December 13, 2017

First Posted

December 18, 2017

Study Start

April 4, 2018

Primary Completion

June 5, 2018

Study Completion

June 6, 2018

Last Updated

August 18, 2020

Record last verified: 2020-08

Locations

KR(1)