Comparison of Nasal Taper-guard Cuffed and a Nasal Cylind... | NCT04503031

Studies
Comparison of Nasal Taper-guard Cuffed and a Nasal Cylindrical Endotracheal Tube

NCT04503031

Sponsor

Kyungpook National University Hospital

Status

Completed

Last Update Posted

Oct 28, 2020Actual

Enrollment

52Actual

Phase

Not Applicable

Conditions

Endotracheal Tube
Cuff Pressure

Interventions

TaperGuard endotracheal tube
cylindrical 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

Oct 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

Jan 10, 2020Actual

Primary Completion Date

Aug 1, 2020Actual

Completion Date

Aug 1, 2020Actual

First Submitted Date

Aug 3, 2020

First Submission Date that Met QC Criteria

Aug 3, 2020

First Posted Date

Aug 6, 2020Actual

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

Oct 26, 2020

Last Update Posted Date

Oct 28, 2020Actual

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)

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

This study was designed to evaluate the effect of change of head position on the cuff pressure of TaperGaurd endotracheal tube , compared to cylindrical endotracheal tube during oral surgery.

Detailed Description

The patient in cylindrical group (n=26) were intubated with cylindrical shaped endotracheal tube (Unomedical, Kedah, Malaysia) and the patient in tapergaurd group (n=26) was intubated with TaperGuard endotracheal tube (Covidien, Athlone, Ireland). The group allocations were informed to the attending anesthesiologist prior to anesthesia. Tracheal intubation was performed with size of inner diameter 7.0 mm endotracheal tube for male and 6.5 mm endotracheal tube for female by the same anesthesiologist. The anesthesiologist measured cuff pressure and distance from endotracheal tube tip to carina during study period.This study was designed to evaluate the effect of change of head position on the cuff pressure of TaperGaurd endotracheal tube, compared to cylindrical endotracheal tube during oral surgery.

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

52Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cylindrical tube group	Active Comparator	The patient in cylindrical tube group (n=26) were intubated with cylindrical shaped endotracheal tube.	Device: cylindrical endotracheal tube
tapergaurd tube group	Experimental	The patient in taperguard tube group (n=26) was intubated with TaperGuard endotracheal tube.	Device: TaperGuard endotracheal tube

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TaperGuard endotracheal tube	Device	TaperGuard endotracheal tube is intubated	tapergaurd tube group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cuff pressure	Cuff pressure is measured with a manometer (Mallinckrodt Medical, Hennef, Germany).	5 minutes after change of head position

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient who were underwent nasal intubation

Exclusion Criteria:

history of difficult intubation, limited neck movement, respiratory diseases and 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, Mr	kyungook national university hospital	Principal Investigator

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

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided