Airway Complication of Anesthesia Clinical Trial
Official title:
Comparison of LMA® Gastro Airway and Gastro-Laryngeal Tube in Endoscopic Retrograde Cholangiopancreatography: a Prospective Randomized Observational Trial
Verified date | November 2020 |
Source | Bezmialem Vakif University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Comparison of second generation supraglottic airway devices about anesthesiologist, endoscopist and patient, which used for gastrointestinal procedures. The investigators believe that the endoscope will be easier to reach by the part of GLT extending to the esophagus, but the structural stiffness of this part may damage the esophageal mucosa. On the other hand, since the endoscopic canal of the LMA® Gastro ends at the upper end of the esophagus, it may be more difficult to orient the endoscope to the esophagus, but it may be superior in terms of ventilation efficiency. Therefore these two device worth for comparing.
Status | Completed |
Enrollment | 100 |
Est. completion date | July 10, 2020 |
Est. primary completion date | June 20, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - ASA Physical Status 1-2 - Elective Procedures - Weight 50-100 Kg Exclusion Criteria: - Laryngeal mask airway contraindications. - Anesthesic drug allergies - Height <155 cm - Body Mass index > 35 kg/m2 - Alcohol or narcotic drug usage - Restrictive or obstructive pulmonary diseases - Hepatic cardiac or renal failure - Psychotic problems - Neurologic or cognitive deficiencies. - Pregnancy - Difficult airway or facial deformities - Previous cervical surgery or cervical radiotherapy - Previous esophagus surgery - High risk of pulmonary aspiration |
Country | Name | City | State |
---|---|---|---|
Turkey | Bezmialem Vakif University | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Bezmialem Vakif University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Oropharyngeal leak pressure | Oropharyngeal leak pressure is the airway pressure at which the circuit pressure stabilizes by closing the expiratory valve of the circle system at a constant gas flow of 3 L / min. | Intra-operative; after device insertion | |
Primary | Endoscopist satisfaction analysis: score | Endoscopist will score from 0 (worst) to 10 (best) | Immediately after the procedure | |
Primary | Leakage rate percentages | The leakage rate percentage is the calculation of the difference between the adjusted tidal volume and the exhaled tidal volume and then proportioning to the adjusted tidal volume. | Intra-operative; after device insertion at first minute | |
Secondary | Hypopharyngeal/Esophageal Mucosal status | Number of patients with hyperemia, laceration (while extubating patient, endoscopist will take pictures of esophagus for if there is any mucosal damage). Esophageal and hypopharyngeal mucosal damage was determined in 5 grades by a visual mucosal damage scoring system [grade 1- normal mucosa, grade 2- mild hyperemia, grade 3-severe hyperemia, grade 4-bloody gross hyperemia, grade 5- laceration]. | Within the first minute after the procedure is completed, while the duodenoscope is being removed while it passes through the esophagus and hypopharynx | |
Secondary | Blood staining on the device | Whether there is blood on the supraglottic airway device or not | Immediately after removing the supraglottic airway device | |
Secondary | Presence of sore throat | Sore throat if present, was classified as mild, moderate or severe. | One hour after extubation |
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