E-T Tube Cuff Pressure Change After Changing Position Fro... | NCT02949856

Studies
E-T Tube Cuff Pressure Change After Changing Position From Neutral to Hyperextension of Neck

NCT02949856

Sponsor

Keimyung University Dongsan Medical Center

Status

Unknown status

Last Update Posted

Oct 31, 2016Estimated

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Thyroidectomy

Interventions

Mallinckrodt, COVIDIEN
Endotracheal tube, Unomedica

Countries

Not provided

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 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2016

Primary Completion Date

Apr 2017Estimated

Completion Date

Jul 2017Estimated

First Submitted Date

Oct 20, 2016

First Submission Date that Met QC Criteria

Oct 27, 2016

First Posted Date

Oct 31, 2016Estimated

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 27, 2016

Last Update Posted Date

Oct 31, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 evaluates difference of the endotracheal tube cuff pressure between a tapered- versus a cylindrical- shaped cuff after changing from neutral to hyperextension of neck.

Fifty patients undergoing thyroidectomy are randomly allocated into two groups (tapered- and cylindrical-shaped cuff). Endotracheal tube cuff pressure is initially set at 20 cmH20 in the supine neutral position and is measured after the change to the neck extension.

Detailed Description

Not provided

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

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tapered	Experimental	Mallinckrodt, COVIDIEN	Device: Mallinckrodt, COVIDIEN
Cylindrical	Active Comparator	Endotracheal tube, Unomedical	Device: Endotracheal tube, Unomedica

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mallinckrodt, COVIDIEN	Device		Tapered
Endotracheal tube, Unomedica

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in intracuff pressure		1 year

Secondary Outcomes

Measure	Description	Time Frame
Change in distance from carina to tip of tube		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

American Society of Anesthesiologists physical classification 1-3, 18-70 year old, thyroidectomy

Exclusion Criteria:

difficult intubation, history of cervical disease, motion limitation of neck, morbid obesity

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yong-Cheol Lee, MD, PhD	Contact	82-53-250-7193		yclee@dsmc.or.kr

Overall Officials

Name	Affiliation	Role
Yong-Cheol Lee, MD, PhD	Keimyung University Dongsan Medical Center	Principal Investigator

Locations

Not provided

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