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

Not Applicable

Completed

• Conditions: Supraglottic Airway Efficiency; Endoscopic Ergonomics; Airway Complication of Anesthesia; Airway Aspiration; Bronchospasm; Complication of Anesthesia; Esophagus Injury; ERCP Airway Management; Bleeding Nose
• Interventions: Device: Wei Nasal Jet Tube; Device: Gastro Laryngeal Tube

• Registration Number: NCT05360810
• Lead Sponsor: Bezmialem Vakif University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-04-29
• Study First Submitted QC: 2022-04-29
• Study First Posted: 2022-05-04
• Study Start: 2022-05-10
• Primary Completion: 2022-08-01
• Study Completion: 2022-08-15
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-14
• Last Update Posted: 2022-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wei Nasal Jet Tube Group (Group W)	Wei Nasal Jet Tube	After induction of anesthesia, the Wei Nasal Jet Tube was placed in the patients.
Gastro-Laryngeal Tube Group (Group G)	Gastro Laryngeal Tube	After the induction of anesthesia, the Gastro Laryngeal Tube was placed in the patients.

Primary Outcome Measures

Name	Time	Method
Hypoxia İncidence	Intra-operative; after device insertion	Hypoxia is defined as SpO2 \<92% at any time.
Endoscopist Satisfaction Analysis: Score	Intra-operative, during the procedure	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Bezmialem Vakif University; 🇹🇷 Istanbul, Turkey