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

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Bezmialem Vakif University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University
• Investigators: Principal Investigator: Harun Uysal, M.D., Bezmialem Vakif University

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2022
• Primary Completion (Actual): August 1, 2022
• Study Completion (Actual): August 15, 2022

Study Registration Dates

• First Submitted: April 29, 2022
• First Submitted That Met QC Criteria: April 29, 2022
• First Posted (Actual): May 4, 2022

Study Record Updates

• Last Update Posted (Actual): September 15, 2022
• Last Update Submitted That Met QC Criteria: September 14, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: ERCP; Gastro-laryngeal tube; Wei Nasal Jet Tube; Airway Complication; Hipoxia
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Bronchial Diseases; Bronchial Spasm
• Other Study ID Numbers: BezmialemVakifU

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No