Comparison of the Cuff Pressure of TaperGuard and Cylindr... | NCT03040440

Studies
Comparison of the Cuff Pressure of TaperGuard and Cylindrical- Endotracheal Tube During Laparoscopic Surgery

NCT03040440

Sponsor

Kyungpook National University Hospital

Status

Completed

Last Update Posted

Feb 2, 2017Estimated

Enrollment

64Actual

Phase

Not Applicable

Conditions

Cuff Pressure

Interventions

Cylindrical endotracheal tube
TaperGaurd endotracheal tube

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

Jan 2017

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

Jun 1, 2016Actual

Primary Completion Date

Dec 15, 2016Actual

Completion Date

Dec 30, 2016Actual

First Submitted Date

Jan 31, 2017

First Submission Date that Met QC Criteria

Jan 31, 2017

First Posted Date

Feb 2, 2017Estimated

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

Jan 31, 2017

Last Update Posted Date

Feb 2, 2017Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Younghoon Jeon, Professor, Kyungpook National University HospitalPrincipal Investigator

Lead Sponsor

Kyungpook National University HospitalOTHER

Collaborators

Not provided

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 purpose of this study was to compare the cuff pressure between cylindrical and TaperGuard endotracheal tube during laparoscopic cholecystectomy.

Detailed Description

Sixty four participants were assigned to one of the two groups: cylindrical and TaperGuard endotracheal tube. At the supine position, cuff pressure of endotracheal tube was measured before and after abdominal insufflation in the supine position. After insufflation the head-up position (30°) was made and cuff pressure was recorded.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cylindrical endotracheal tube	Active Comparator	Cylindrical endotracheal tube was intubated in 32 participants	Device: Cylindrical endotracheal tube
TaperGuard endotracheal tube	Experimental	TaperGuard endotracheal tube was intubated in 32 participants	Device: TaperGaurd endotracheal tube

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cylindrical endotracheal tube	Device	Cylindrical endotracheal tube was intubated	Cylindrical endotracheal tube

Measure	Description	Time Frame
cuff pressure		5 minutes after intubation

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants who were underwent laparoscopic cholecystectomy with American Society of Anesthesiologists physical status 1-3

Exclusion Criteria:

history with respiratory disease, difficult intubation, and morbid obesity (body mass index more than 35 kg/m2).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Younghoon Jeon, MD	Kyungpook National University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kyungpook National University Hospital		Daegu		700-721	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided