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

Primary Purpose

Supraglottic Airway Efficiency, Airway Complication of Anesthesia, Airway Aspiration

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Wei Nasal Jet Tube
Gastro Laryngeal Tube
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Supraglottic Airway Efficiency focused on measuring Wei Nasal Jet Tube, Gastro-laryngeal tube, ERCP, Airway Complication, Hipoxia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bezmialem Vakif University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Wei Nasal Jet Tube Group (Group W)

Gastro-Laryngeal Tube Group (Group G)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Hypoxia İncidence
Hypoxia is defined as SpO2 <92% at any time.
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.

Secondary Outcome Measures

Blood staining on the device
Whether there is blood on the supraglottic airway device or not
Presence of sore throat
Sore throat if present, was classified as mild, moderate or severe.
Incidence of hypercapnia
Hypercapnia is EtCO2 >45 mmHg at any time during the procedure

Full Information

First Posted
April 29, 2022
Last Updated
September 14, 2022
Sponsor
Bezmialem Vakif University
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1. Study Identification

Unique Protocol Identification Number
NCT05360810
Brief Title
Wei Nasal Jet Tube vs Gastro Laryngeal Tube in Endoscopic Retrograde Cholangiopancreatography
Official Title
Comparison of Wei Nasal Jet Tube vs Gastro Laryngeal Tube in Endoscopic Retrograde Cholangiopancreatography: A Prospective, Randomized, Observational Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
May 10, 2022 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
August 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bezmialem Vakif University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Single (Participant) closed envelope technique
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wei Nasal Jet Tube Group (Group W)
Arm Type
Active Comparator
Arm Description
After induction of anesthesia, the Wei Nasal Jet Tube was placed in the patients.
Arm Title
Gastro-Laryngeal Tube Group (Group G)
Arm Type
Active Comparator
Arm Description
After the induction of anesthesia, the Gastro Laryngeal Tube was placed in the patients.
Intervention Type
Device
Intervention Name(s)
Wei Nasal Jet Tube
Other Intervention Name(s)
Comparison of LMA Gastro Airway® and Gastro-Laryngeal Tube in patients who will ERCP procedures.
Intervention Description
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
Intervention Name(s)
Gastro Laryngeal Tube
Other Intervention Name(s)
Comparison of LMA Gastro Airway® and Gastro-Laryngeal Tube in patients who will ERCP procedures.
Intervention Description
comparing efficiency and complications of second generation airway devices which can use for gastrointestinally procedures
Primary Outcome Measure Information:
Title
Hypoxia İncidence
Description
Hypoxia is defined as SpO2 <92% at any time.
Time Frame
Intra-operative; after device insertion
Title
Endoscopist Satisfaction Analysis: Score
Description
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.
Time Frame
Intra-operative, during the procedure
Secondary Outcome Measure Information:
Title
Blood staining on the device
Description
Whether there is blood on the supraglottic airway device or not
Time Frame
Immediately after removing the supraglottic airway device
Title
Presence of sore throat
Description
Sore throat if present, was classified as mild, moderate or severe.
Time Frame
One hour after extubation
Title
Incidence of hypercapnia
Description
Hypercapnia is EtCO2 >45 mmHg at any time during the procedure
Time Frame
Intra-operative; after device insertion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harun Uysal, M.D.
Organizational Affiliation
Bezmialem Vakif University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bezmialem Vakif University
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

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

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