Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-02-10 @ 8:47 AM
Study NCT ID:
NCT01401205
Status:
COMPLETED
Last Update Posted:
2013-12-25
First Post:
2011-07-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Predictor of Respiratory Discomfort After the Shoulder Arthroscopic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004417', 'term': 'Dyspnea'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-24', 'studyFirstSubmitDate': '2011-07-21', 'studyFirstSubmitQcDate': '2011-07-22', 'lastUpdatePostDateStruct': {'date': '2013-12-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Airway transverse diameter', 'timeFrame': '10 min before anesthesia induction', 'description': 'airway transverses diameter measured on the upper airway ultrasonographic image: measure at three level (vocal cord, subglottis, trachea)'}, {'measure': 'Airway transverse diameter', 'timeFrame': '20 min after end of surgery', 'description': 'airway transverses diameter measured on the upper airway ultrasonographic image: measure at three level (vocal cord, subglottis, trachea)'}], 'secondaryOutcomes': [{'measure': 'depth of skin to airway anterior border', 'timeFrame': '10 min before anesthesia induction and 20 min after the surgery', 'description': 'depth of skin to airway anterior border measured at three levels: vocal cord, subglottis, trachea level'}, {'measure': 'depth of skin to pleura', 'timeFrame': '10 min before anesthesia induction and 20 min after the end of surgery', 'description': 'bilateral depth of skin to pleura at first and third intercostal space on the midclavicualr line measuread on the ultrasonographic image'}, {'measure': 'endotracheal tube balloon cuff pressure', 'timeFrame': '10 min after anesthesia induction and 60 min after surgery start', 'description': 'endotracheal tube balloon cuff pressure'}, {'measure': 'percent cuff leak', 'timeFrame': '10 min after anesthesia induction and 60 min after surgery start', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['shoulder arthroscopic surgery', 'dyspnea', 'airway diameter'], 'conditions': ['Shoulder Arthroscopic Surgery']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nAn 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients undergoing elective shoulder arthroscopic surgery (rotator cuff repair)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing elective shoulder arthroscopic surgery (rotator cuff repair)\n\nExclusion Criteria:\n\n* patients with airway anomaly\n* patients with anticipated difficult airway\n* patients with hemodynamic unstability\n* patients with severe cardiopulmonary disease'}, 'identificationModule': {'nctId': 'NCT01401205', 'briefTitle': 'The Predictor of Respiratory Discomfort After the Shoulder Arthroscopic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'The Predictor of Respiratory Discomfort After the Shoulder Arthroscopic Surgery as Measured by Upper Airway Ultrasonography', 'orgStudyIdInfo': {'id': '2011-06-028'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'shoulder arthroscopic surgery group', 'description': 'the patients who undergo the elective shoulder arthroscopic surgery of rotator cuff repair', 'interventionNames': ['Other: upper airway ultrasonographic examination']}], 'interventions': [{'name': 'upper airway ultrasonographic examination', 'type': 'OTHER', 'otherNames': ['upper airway ultrasonographic examination ,', 'cuff leak test'], 'description': 'upper airway ultrasonographic examination and cuff leak test', 'armGroupLabels': ['shoulder arthroscopic surgery group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Soo Joo Choi, M.D.,Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sujoo Choi', 'investigatorAffiliation': 'Samsung Medical Center'}}}}