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

Airway Complication of Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05360810
• Other study ID #: BezmialemVakifU
• Status: Completed
• Phase: N/A
• Start date: May 10, 2022
• Est. completion date: August 15, 2022

Study information

• Verified date: September 2022
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: August 15, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Airway Aspiration
• Airway Complication of Anesthesia
• Bronchial Spasm
• Bronchospasm
• Complication of Anesthesia
• Endoscopic Ergonomics
• ERCP Airway Management
• Esophagus Injury
• Supraglottic Airway Efficiency

Intervention

Device:
• 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
• Gastro Laryngeal Tube
comparing efficiency and complications of second generation airway devices which can use for gastrointestinally procedures

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypoxia Incidence	Hypoxia is defined as SpO2 <92% at any time.	Intra-operative; after device insertion
Primary	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	Blood staining on the device	Whether there is blood on the supraglottic airway device or not	Immediately after removing the supraglottic airway device
Secondary	Presence of sore throat	Sore throat if present, was classified as mild, moderate or severe.	One hour after extubation
Secondary	Incidence of hypercapnia	Hypercapnia is EtCO2 >45 mmHg at any time during the procedure	Intra-operative; after device insertion