The Effect of Esophageal Temperature Probe Insertion on T... | NCT03375554

Studies
The Effect of Esophageal Temperature Probe Insertion on Tracheal Cuff Pressure

NCT03375554

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Aug 18, 2020Actual

Enrollment

112Actual

Phase

Not provided

Conditions

Intubation Complication

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 4, 2018Actual

Primary Completion Date

Jun 5, 2018Actual

Completion Date

Jun 6, 2018Actual

First Submitted Date

Dec 13, 2017

First Submission Date that Met QC Criteria

Dec 13, 2017

First Posted Date

Dec 18, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 14, 2020

Last Update Posted Date

Aug 18, 2020Actual

Name	Class
SMG-SNU Boramae Medical Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

It is well known that cuff pressure of tracheal tube should not be over 30 cmH2O. Therefore, anesthesiologists usually pay attention to maintain adequate cuff pressure, especially just after completion of tracheal intubation. Recently, esophageal stethoscope is widely used for exact monitoring of patient's body temperature. However, inserting of foreign body in esophagus could affect on the cuff pressure.

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

112Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of cuff pressure	Change of cuff pressure by inserting of esophageal stethoscope, compared with before insertion of it	intraoperative

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient receiving general anesthesia for elective surgery

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patient receiving general anesthesia for elective surgery

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jung-Man Lee, M.D.,PhD	SMG-SNU Boramae Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul Metropolitan Government Seoul National University Boramae Medical Center		Seoul		07061	South Korea