- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01401205
The Predictor of Respiratory Discomfort After the Shoulder Arthroscopic Surgery
The Predictor of Respiratory Discomfort After the Shoulder Arthroscopic Surgery as Measured by Upper Airway Ultrasonography
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
During shoulder arthroscopic surgery, extravasation of irrigation fluid can occur around the shoulder and trachea, compressing the upper airway. Although the extravasation is generally reabsorbed asymptomatically within 12 hours, there are cases that lead to reintubation or life-threatening complications.
An endotracheal tube is the most reliable method of securing the airway from airway obstruction during a shoulder arthroscopy surgery. However, since the airway may become obstructed after extubation, airway patency should be verified before extubation. Direct visualization of the larynx or trachea using laryngoscopy or bronchoscopy is difficult due to the presence of the tracheal tube. A cuff leak around the tracheal tube in a cuff-deflated condition is suggested to be a predictor of successful extubation. However, its reliability has been questioned in adult patients. A cuff leak could be affected by paratracheal pressure, which is thought to be elevated during shoulder arthroscopy. In a recent study, it was shown that laryngeal ultrasound can be a reliable, non-invasive method for the evaluation of laryngeal morphology or predicting post-extubation stridor.
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Seoul, Korea, Republic of, 135-710
- Samsung Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients undergoing elective shoulder arthroscopic surgery (rotator cuff repair)
Exclusion Criteria:
- patients with airway anomaly
- patients with anticipated difficult airway
- patients with hemodynamic unstability
- patients with severe cardiopulmonary disease
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
shoulder arthroscopic surgery group
the patients who undergo the elective shoulder arthroscopic surgery of rotator cuff repair
|
upper airway ultrasonographic examination and cuff leak test
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Airway transverse diameter
Time Frame: 10 min before anesthesia induction
|
airway transverses diameter measured on the upper airway ultrasonographic image: measure at three level (vocal cord, subglottis, trachea)
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10 min before anesthesia induction
|
Airway transverse diameter
Time Frame: 20 min after end of surgery
|
airway transverses diameter measured on the upper airway ultrasonographic image: measure at three level (vocal cord, subglottis, trachea)
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20 min after end of surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
depth of skin to airway anterior border
Time Frame: 10 min before anesthesia induction and 20 min after the surgery
|
depth of skin to airway anterior border measured at three levels: vocal cord, subglottis, trachea level
|
10 min before anesthesia induction and 20 min after the surgery
|
depth of skin to pleura
Time Frame: 10 min before anesthesia induction and 20 min after the end of surgery
|
bilateral depth of skin to pleura at first and third intercostal space on the midclavicualr line measuread on the ultrasonographic image
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10 min before anesthesia induction and 20 min after the end of surgery
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endotracheal tube balloon cuff pressure
Time Frame: 10 min after anesthesia induction and 60 min after surgery start
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endotracheal tube balloon cuff pressure
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10 min after anesthesia induction and 60 min after surgery start
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percent cuff leak
Time Frame: 10 min after anesthesia induction and 60 min after surgery start
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The difference in the actual exhaled volume between the averages of pre- and post-cuff deflation was calculated.
This number was divided by the tidal volume before cuff deflation and multiplied by 100.
The resulting number was recorded as the percent cuff leak.
|
10 min after anesthesia induction and 60 min after surgery start
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Soo Joo Choi, M.D.,Ph.D., Samsung Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2011-06-028
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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