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

B

Bezmialem Vakif University

Status

Completed

Conditions

Supraglottic Airway Efficiency
ERCP Airway Management
Esophagus Injury
Airway Complication of Anesthesia
Airway Aspiration
Bronchospasm
Endoscopic Ergonomics
Complication of Anesthesia
Bleeding Nose

Treatments

Device: Gastro Laryngeal Tube
Device: Wei Nasal Jet Tube

Study type

Interventional

Funder types

Other

Identifiers

NCT05360810
BezmialemVakifU

Details and patient eligibility

About

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.

Full 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.

Enrollment

114 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

114 participants in 2 patient groups

Wei Nasal Jet Tube Group (Group W)
Active Comparator group
Description:
After induction of anesthesia, the Wei Nasal Jet Tube was placed in the patients.
Treatment:
Device: Wei Nasal Jet Tube
Gastro-Laryngeal Tube Group (Group G)
Active Comparator group
Description:
After the induction of anesthesia, the Gastro Laryngeal Tube was placed in the patients.
Treatment:
Device: Gastro Laryngeal Tube

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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