The Predictor of Respiratory Discomfort After the Shoulder Arthroscopic Surgery
1 other identifier
observational
100
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2011
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
July 21, 2011
CompletedFirst Posted
Study publicly available on registry
July 25, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedDecember 25, 2013
December 1, 2013
1.4 years
July 21, 2011
December 24, 2013
Conditions
Keywords
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
Interventions
upper airway ultrasonographic examination and cuff leak test
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Soo Joo Choi, M.D.,Ph.D.
Samsung Medical Center
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