Clinical trial NCT05360810: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2022-05-04
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Hypoxia İncidence
timeFrame: Intra-operative; after device insertion
measure: Endoscopist Satisfaction Analysis: Score
timeFrame: Intra-operative, during the procedure
Secondary outcomes:
measure: Blood staining on the device
timeFrame: Immediately after removing the supraglottic airway device
measure: Presence of sore throat
timeFrame: One hour after extubation
measure: Incidence of hypercapnia
timeFrame: Intra-operative; after device insertion
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
Study officials:
affiliation: Bezmialem Vakif University
name: Harun Uysal, M.D.
role: PRINCIPAL_INVESTIGATOR
References: