Effects of Shoulder Edema on Intubated Tube in Patients U... | NCT02184702

Studies
Effects of Shoulder Edema on Intubated Tube in Patients Undergoing Shoulder Arthroscopy

NCT02184702

Sponsor

Inje University

Status

Completed

Last Update Posted

Aug 31, 2016Estimated

Enrollment

40Actual

Phase

Not provided

Conditions

Arthroscopy

Interventions

Not provided

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

Aug 2016

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 2014

Primary Completion Date

Jul 2016Actual

Completion Date

Jul 2016Actual

First Submitted Date

Jul 3, 2014

First Submission Date that Met QC Criteria

Jul 8, 2014

First Posted Date

Jul 9, 2014Estimated

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

Aug 29, 2016

Last Update Posted Date

Aug 31, 2016Estimated

Name	Class
Fresenius Kabi Korea	UNKNOWN

Description Module

Brief Summary

Intubation is needed in general anesthesia and appropriate cuff pressure is important to avoid trauma or postoperative sore throat and aspiration. Shoulder arthroscope uses some amount of irrigation fluid and it can influence to cuff pressure. Therefore, we will measure cuff pressure during shoulder arthroscope.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Label	Type	Description	Intervention Names
shoulder arthroscopy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Direct intracuff pressure measurement technique using manometer		every one hour during operarion

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

American Society of Anesthesiologists (ASA) 1,2 Age 20-65

Exclusion Criteria:

emergency operation anticipated difficult intubation chronic obstructive lung disease recent upper respiratory infection

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Patints who undergoing shoulder arthroscopy American Society of Anesthesiologists (ASA) 1,2

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sira Bang, MD, PhD	Inje University Seoul Paik Hospital, Seoul, Korea	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Inje University Seoul Paik Hospital, Seoul, Korea		Seoul	Jung-Gu	100-032	South Korea