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Completed

NCT Number: NCT05360810

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

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.

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Key information

Conditions

Supraglottic Airway Efficiency Airway Aspiration Airway Complication of Anesthesia Bleeding Nose Bronchial Diseases Bronchial Spasm Bronchospasm Complication of Anesthesia ERCP Airway Management Endoscopic Ergonomics Epistaxis Esophagus Injury Hemorrhage Nose Diseases Otorhinolaryngologic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Gastro Laryngeal Tube

Device

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.

Primary outcomes

  1. Hypoxia İncidence

    Time frame: Intra-operative; after device insertion

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

  2. Endoscopist Satisfaction Analysis: Score

    Time frame: Intra-operative, during the procedure

    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 outcomes

  1. Blood staining on the device

    Time frame: Immediately after removing the supraglottic airway device

    Whether there is blood on the supraglottic airway device or not

  2. Presence of sore throat

    Time frame: One hour after extubation

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

  3. Incidence of hypercapnia

    Time frame: Intra-operative; after device insertion

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

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 4, 2022
Registry last updated
Sep 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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