ClinicalTrials.gg
CompletedNCT05360810Updated Sep 15, 2022

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

An interventional study of Wei Nasal Jet Tube and Gastro Laryngeal Tube in Supraglottic Airway Efficiency, Airway Complication of Anesthesia and Airway Aspiration, sponsored by Bezmialem Vakif University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-09-15.

Sponsored by Bezmialem Vakif University · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
114
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Epistaxis

96 studies on the registry are indexed under Epistaxis; 22 are open to participants now.

This study's enrollment of 114 is above the median of 64 across 81 interventional studies indexed under Epistaxis.

Browse Epistaxis studies →

Lead sponsor

Bezmialem Vakif University is the lead sponsor of 354 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
114 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DeviceWei 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

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

  • DeviceGastro Laryngeal Tube

    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.

06

What researchers measure

Primary outcomes

  1. Hypoxia İncidence

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

    Time frame: Intra-operative; after device insertion

  2. 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.

    Time frame: Intra-operative, during the procedure

Secondary outcomes

  1. Blood staining on the device

    Whether there is blood on the supraglottic airway device or not

    Time frame: Immediately after removing the supraglottic airway device

  2. Presence of sore throat

    Sore throat if present, was classified as mild, moderate or severe.

    Time frame: One hour after extubation

  3. Incidence of hypercapnia

    Hypercapnia is EtCO2 \>45 mmHg at any time during the procedure

    Time frame: Intra-operative; after device insertion

07

Study locations

1 site
  • Bezmialem Vakif University
    Istanbul, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05360810
Responsible party
Harun UYSAL (Principal Investigator, Bezmialem Vakif University) — Principal investigator
First posted
May 4, 2022
Start date
May 10, 2022
Primary completion
Aug 1, 2022
Completion
Aug 15, 2022
Last update
Sep 15, 2022

Study contacts

Harun Uysal, M.D.
principal investigator · Bezmialem Vakif University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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