NCT01401205

Brief Summary

The investigators applied upper airway ultrasonographic examination focusing the measurement of upper airway diameters in patients undergoing shoulder arthroscopic surgery to evaluate the change of upper airway anatomy before and after the surgery. The investigators also tried to find any findings of ultrasonographic examination that could reliably predict the dyspnea or airway compression after extubation. The investigators tried to compare the ultrasonographic findings with those of chest radiograph to validate the measurements of the ultrasonographic examination. A cuff leak test was preformed to evaluate its ability to predict the upper airway obstruction in shoulder arthroscopic surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2011

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 21, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 25, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

December 25, 2013

Status Verified

December 1, 2013

Enrollment Period

1.4 years

First QC Date

July 21, 2011

Last Update Submit

December 24, 2013

Conditions

Keywords

shoulder arthroscopic surgerydyspneaairway diameter

Outcome Measures

Primary Outcomes (2)

  • Airway transverse diameter

    airway transverses diameter measured on the upper airway ultrasonographic image: measure at three level (vocal cord, subglottis, trachea)

    10 min before anesthesia induction

  • Airway transverse diameter

    airway transverses diameter measured on the upper airway ultrasonographic image: measure at three level (vocal cord, subglottis, trachea)

    20 min after end of surgery

Secondary Outcomes (4)

  • depth of skin to airway anterior border

    10 min before anesthesia induction and 20 min after the surgery

  • depth of skin to pleura

    10 min before anesthesia induction and 20 min after the end of surgery

  • endotracheal tube balloon cuff pressure

    10 min after anesthesia induction and 60 min after surgery start

  • percent cuff leak

    10 min after anesthesia induction and 60 min after surgery start

Study Arms (1)

shoulder arthroscopic surgery group

the patients who undergo the elective shoulder arthroscopic surgery of rotator cuff repair

Other: upper airway ultrasonographic examination

Interventions

upper airway ultrasonographic examination and cuff leak test

Also known as: upper airway ultrasonographic examination ,, cuff leak test
shoulder arthroscopic surgery group

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients undergoing elective shoulder arthroscopic surgery (rotator cuff repair)

You may qualify if:

  • patients undergoing elective shoulder arthroscopic surgery (rotator cuff repair)

You may not qualify if:

  • patients with airway anomaly
  • patients with anticipated difficult airway
  • patients with hemodynamic unstability
  • patients with severe cardiopulmonary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Soo Joo Choi, M.D.,Ph.D.

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 21, 2011

First Posted

July 25, 2011

Study Start

July 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

December 25, 2013

Record last verified: 2013-12

Locations