Wei Nasal Jet Tube vs Gastro Laryngeal Tube in Endoscopic Retrograde Cholangiopancreatography

Study Overview
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Brief Summary
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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.

Detailed Description
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ERCP is a procedure that requires intolerable positioning, prolonged air insufflation, and deep levels of anesthesia. The procedure can be performed under general anesthesia or with deep sedation. It becomes more difficult to maintain airway patency in the prone position under deep sedation. Clinicians prefer supraglottic airway devices developed for endoscopic procedures. GLT requires a deeper level of anesthesia. WNJ, on the other hand, can be tolerated with less depth levels of anesthesia. It has been reported in the literature that GLT and WNJ are effective in maintaining patent airway and preventing hypoxia in ERCP procedures. However, both airway devices have not been compared for airway efficiency and ERCP procedure condition. In this study, the investigators aimed to compare airway efficiency and procedure condition using GLT and WNJ.

Official Title
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Comparison of Wei Nasal Jet Tube vs Gastro Laryngeal Tube in Endoscopic Retrograde Cholangiopancreatography: A Prospective, Randomized, Observational Study

Conditions
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Airway Aspiration, Supraglottic Airway Efficiency, Airway Complication of Anesthesia, Complication of Anesthesia, Esophagus Injury, Endoscopic Ergonomics, ERCP Airway Management, Bleeding Nose, Bronchospasm

Intervention / Treatment
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* Device: Wei Nasal Jet Tube
* Device: Gastro Laryngeal Tube


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Wei Nasal Jet Tube Group (Group W)<br>After induction of anesthesia, the Wei Nasal Jet Tube was placed in the patients. | Device: Wei Nasal Jet Tube<br>* comparing efficiency and complications of second generation airway devices which can use for gastrointestinally procedures airway devices which can use for gastrointestinal procedures<br>* Other names: Comparison of LMA Gastro Airway® and Gastro-Laryngeal Tube in patients who will ERCP procedures.;|
| Active Comparator: Gastro-Laryngeal Tube Group (Group G)<br>After the induction of anesthesia, the Gastro Laryngeal Tube was placed in the patients. | Device: Gastro Laryngeal Tube<br>* comparing efficiency and complications of second generation airway devices which can use for gastrointestinally procedures<br>* Other names: Comparison of LMA Gastro Airway® and Gastro-Laryngeal Tube in patients who will ERCP procedures.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoxia İncidence | Hypoxia is defined as SpO2 <92% at any time. | Intra-operative; after device insertion | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood staining on the device | Whether there is blood on the supraglottic airway device or not | Immediately after removing the supraglottic airway device | 
| Presence of sore throat | Sore throat if present, was classified as mild, moderate or severe. | One hour after extubation | 
| Incidence of hypercapnia | Hypercapnia is EtCO2 >45 mmHg at any time during the procedure | Intra-operative; after device insertion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ERCP, Wei Nasal Jet Tube, Gastro-laryngeal tube, Airway Complication, Hipoxia