Heated Breathing Circuit on Postoperative Sore Throat Aft... | NCT03689127

Studies
Heated Breathing Circuit on Postoperative Sore Throat After Double-lumen Endobronchial Tube Insertion

NCT03689127

Sponsor

Keimyung University Dongsan Medical Center

Status

Unknown status

Last Update Posted

Sep 28, 2018Actual

Enrollment

106Estimated

Phase

Not Applicable

Conditions

Lung Surgery

Interventions

Heated breathing circuit on
Heated breathing circuit off

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

Sep 2018

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

Nov 2018Estimated

Primary Completion Date

Nov 2019Estimated

Completion Date

Nov 2019Estimated

First Submitted Date

Sep 27, 2018

First Submission Date that Met QC Criteria

Sep 27, 2018

First Posted Date

Sep 28, 2018Actual

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

Sep 27, 2018

Last Update Posted Date

Sep 28, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hyun-Chang Kim, Assistant professor, Keimyung University Dongsan Medical CenterPrincipal Investigator

Lead Sponsor

Keimyung University Dongsan Medical CenterOTHER

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

This investigation is planned to compare the incidence and severity of postoperative sore throat according to the use of heated breathing circuit in patients undergoing double-lumen endotracheal intubation.

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

106Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Active Comparator	Heated breathing circuit will be turned off.	Device: Heated breathing circuit off
Heat	Experimental	Heated breathing circuit will be turned on.	Device: Heated breathing circuit on

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Heated breathing circuit on	Device	Heated breathing circuit will be turned on.	Heat

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with postoperative sore throat for postoperative 24 h		At 24 hours

Secondary Outcomes

Measure	Description	Time Frame
Number of participants with postoperative sore throat		At 1, 6, and 24 hours
Postoperative sore throat scores		At 1, 6, and 24 hours
Number of participants with postoperative hoarseness

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA I-III
Patients scheduled for double-lumen endotracheal intubation

Exclusion Criteria:

Difficult airway
Mallampatti scores greater than 2
Recent sore throat
Cervical spine disease
Recent upper respiratory infection
Recent analgesics
History of head and neck surgery
Friable teeth
Multiple intubation attempts

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hyun Chang Kim	Contact	+821028862876		onidori1979@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hyun-Chang Kim		Daegu	Non-US/Canada	137-040	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010612	Pharyngitis

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D010608	Pharyngeal Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided