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

NCT05360810 | Completed

• 1 other identifier: BezmialemVakifU
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Wei Nasal Jet Tube; Gastro-laryngeal tube; ERCP; Airway Complication; Hipoxia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Blood staining on the device

  Immediately after removing the supraglottic airway device

• Presence of sore throat

  One hour after extubation

• Incidence of hypercapnia

  Intra-operative; after device insertion

Study Arms (2)

Wei Nasal Jet Tube Group (Group W)

ACTIVE COMPARATOR

After induction of anesthesia, the Wei Nasal Jet Tube was placed in the patients.

Device: Wei Nasal Jet Tube

Gastro-Laryngeal Tube Group (Group G)

ACTIVE COMPARATOR

After the induction of anesthesia, the Gastro Laryngeal Tube was placed in the patients.

Device: Gastro Laryngeal Tube

Interventions

Wei Nasal Jet Tube DEVICE

comparing efficiency and complications of second generation airway devices which can use for gastrointestinally procedures airway devices which can use for gastrointestinal procedures

Also known as: Comparison of LMA Gastro Airway® and Gastro-Laryngeal Tube in patients who will ERCP procedures.

Wei Nasal Jet Tube Group (Group W)

Gastro Laryngeal Tube DEVICE

comparing efficiency and complications of second generation airway devices which can use for gastrointestinally procedures

Also known as: Comparison of LMA Gastro Airway® and Gastro-Laryngeal Tube in patients who will ERCP procedures.

Gastro-Laryngeal Tube Group (Group G)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA Physical Status 1-2
• Elective Procedures
• Body mass index 18.5 - 35 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Epistaxis; Bronchial Spasm

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms; Bronchial Diseases

Study Officials

• Harun Uysal, M.D.

  Bezmialem Vakif University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single (Participant) closed envelope technique
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: May 4, 2022
• Study Start: May 10, 2022
• Primary Completion: August 1, 2022
• Study Completion: August 15, 2022
• Last Updated: September 15, 2022

Record last verified: 2022-09

Locations

TU (1)