Airway Complication of Anesthesia Clinical Trial
Official title:
Comparison of Wei Nasal Jet Tube vs Gastro Laryngeal Tube in Endoscopic Retrograde Cholangiopancreatography: A Prospective, Randomized, Observational Study
Verified date | September 2022 |
Source | Bezmialem Vakif University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The most common adverse event in endoscopic procedures is hypoxia. Different airway devices have been investigated in the literature to prevent hypoxia. This study aimed to compare the efficacy and procedural performance of two different airway (GLT and WNJ) devices in ERCP procedures.
Status | Completed |
Enrollment | 114 |
Est. completion date | August 15, 2022 |
Est. primary completion date | August 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - ASA Physical Status 1-2 - Elective Procedures - Body mass index 18.5 - 35 kg/m2 Exclusion Criteria: - High risk of pulmonary aspiration - Pregnancy - Anesthesic drug allergies - Difficult airway or facial deformities - Height <155 cm - Alcohol or narcotic drug usage - Restrictive or obstructive pulmonary diseases - Hepatic cardiac or renal failure - Neurologic or cognitive deficiencies. - Previous cervical surgery or cervical radiotherapy - Previous esophagus surgery - Psychotic problems |
Country | Name | City | State |
---|---|---|---|
Turkey | Bezmialem Vakif University | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Bezmialem Vakif University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hypoxia Incidence | Hypoxia is defined as SpO2 <92% at any time. | Intra-operative; after device insertion | |
Primary | Endoscopist Satisfaction Analysis: Score | It is determined by the endoscopist according to the endoscopy satisfaction scale according to the maneuverability of the duodenoscope and the number of insertion attempts. (0-10 Points) The endocopist satisfaction score is scored on a minimum score of 0 and a maximum of 10 points. A score of 0 means I am not satisfied at all, a score of 10 means very satisfied. A higher score indicates higher satisfaction. | Intra-operative, during the procedure | |
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 | |
Secondary | Incidence of hypercapnia | Hypercapnia is EtCO2 >45 mmHg at any time during the procedure | Intra-operative; after device insertion |
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