Insertion Time Over Fiberoptic Bronchoscope of Double Lum... | NCT03173443

Studies
Insertion Time Over Fiberoptic Bronchoscope of Double Lumen Tube and Single Lumen Tube

NCT03173443

Sponsor

Ajou University School of Medicine

Status

Completed

Last Update Posted

Jan 9, 2018Actual

Enrollment

89Actual

Phase

Not Applicable

Conditions

Intubation;Difficult

Interventions

single lumen tube and bronchial blocker
double lumen 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 2018

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

May 31, 2017Actual

Primary Completion Date

Aug 26, 2017Actual

Completion Date

Aug 26, 2017Actual

First Submitted Date

May 30, 2017

First Submission Date that Met QC Criteria

May 30, 2017

First Posted Date

Jun 1, 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

Jan 5, 2018

Last Update Posted Date

Jan 9, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

DAE HEE KIM, Assistant Professor, Ajou University School of MedicinePrincipal Investigator

Lead Sponsor

Ajou University School of MedicineOTHER

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

One lung ventilation (OLV) is required during thoracic procedures such as lung and esophagus surgery. three technique can be employed. (1) placement of a double-lumen bronchial tube (DLT); (2) use of a single-lumen tracheal tube (SLT) in conjunction with a bronchial blocker; (3) insertion of a conventional SLT into a main bronchus. Flexible fiberoptic intubation with SLT is well established technique for anticipated or unexpected difficult intubation. But, little is known about flexible fiberoptic intubation with DLT.

The investigators compared insertion time over fiberoptic bronchoscope between SLT with bronchial blocker and DLT in patients undergoing thoracic surgery.

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

89Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
single lumen tube	Experimental	fiberoptic intubation with single lumen tube with bronchial blocker.	Device: single lumen tube and bronchial blocker
double lumen tube	Experimental	fiberoptic intubation with double lumen tube.	Device: double lumen tube

Interventions

Name	Type	Description	Arm Group Labels	Other Names
single lumen tube and bronchial blocker	Device	fiberoptic intubation with single lumen tube and bronchial blocker	single lumen tube

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
insertion time	time from insertion of bronchoscope into mouth to tube placement at trachea or bronchus	at anesthesia induction

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients undergoing thoracic surgery and one lung ventilation American Society of Anesthesiology Physical status 1,2

Exclusion Criteria:

abnormality of upper airway, gastroesophageal disease, risk of aspiration, BMI > 35

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dae Hee Kim, M.D.	Ajou unversity hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ajou universiry hospital		Suwon	Gyeonggi-do	16499	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