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

NCT ID: NCT05360810

Last Updated: 2022-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-10
• Study Completion Date: 2022-08-15

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

Wei Nasal Jet Tube Group (Group W)

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

Group Type: ACTIVE_COMPARATOR

Wei Nasal Jet Tube

Intervention Type: DEVICE

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

airway devices which can use for gastrointestinal procedures

Gastro-Laryngeal Tube Group (Group G)

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

Group Type: ACTIVE_COMPARATOR

Gastro Laryngeal Tube

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Gastro Laryngeal Tube

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

Intervention Type: DEVICE

Other Intervention Names

Comparison of LMA Gastro Airway® and Gastro-Laryngeal Tube in patients who will ERCP procedures.; Comparison of LMA Gastro Airway® and Gastro-Laryngeal Tube in patients who will ERCP procedures.

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bezmialem Vakif University

OTHER

Sponsor Role: lead

Responsible Party

Harun UYSAL

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Harun Uysal, M.D.

Role: PRINCIPAL_INVESTIGATOR

Bezmialem Vakif University

Locations

Bezmialem Vakif University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

BezmialemVakifU

Identifier Type: -

Identifier Source: org_study_id