NCT02184702

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 3, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 9, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

August 31, 2016

Status Verified

August 1, 2016

Enrollment Period

2.1 years

First QC Date

July 3, 2014

Last Update Submit

August 29, 2016

Conditions

Arthroscopy

Outcome Measures

Primary Outcomes (1)

  • Direct intracuff pressure measurement technique using manometer

    every one hour during operarion

Study Arms (1)

shoulder arthroscopy

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inje University Seoul Paik Hospital, Seoul, Korea

Seoul, Jung-Gu, 100-032, South Korea

Location

Study Officials

  • Sira Bang, MD, PhD

    Inje University Seoul Paik Hospital, Seoul, Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

July 3, 2014

First Posted

July 9, 2014

Study Start

June 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

August 31, 2016

Record last verified: 2016-08

Locations

KR(1)