LMA® Gastro Airway Versus Gastro-Laryngeal Tube in Endoscopic Retrograde Cholangiopancreatography

NCT04196582 | Completed

• 1 other identifier: Bezmialem Vakif University
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Comparison of second generation supraglottic airway devices about anesthesiologist, endoscopist and patient, which used for gastrointestinal procedures. The investigators believe that the endoscope will be easier to reach by the part of GLT extending to the esophagus, but the structural stiffness of this part may damage the esophageal mucosa. On the other hand, since the endoscopic canal of the LMA® Gastro ends at the upper end of the esophagus, it may be more difficult to orient the endoscope to the esophagus, but it may be superior in terms of ventilation efficiency. Therefore these two device worth for comparing.

Conditions

Supraglottic Airway Efficiency; Airway Complication of Anesthesia; Airway Aspiration; Complication of Anesthesia; Esophagus Injury; Endoscopic Ergonomics; ERCP Airway Management

Keywords

LMA gastro airway; Gastro-laryngeal tube; ERCP; airway complications

Outcome Measures

Primary Outcomes (3)

• Oropharyngeal leak pressure

  Oropharyngeal leak pressure is the airway pressure at which the circuit pressure stabilizes by closing the expiratory valve of the circle system at a constant gas flow of 3 L / min.

  Intra-operative; after device insertion

• Endoscopist satisfaction analysis: score

  Endoscopist will score from 0 (worst) to 10 (best)

  Immediately after the procedure

• Leakage rate percentages

  The leakage rate percentage is the calculation of the difference between the adjusted tidal volume and the exhaled tidal volume and then proportioning to the adjusted tidal volume.

  Intra-operative; after device insertion at first minute

Secondary Outcomes (3)

• Hypopharyngeal/Esophageal Mucosal status

  Within the first minute after the procedure is completed, while the duodenoscope is being removed while it passes through the esophagus and hypopharynx

• Blood staining on the device

  Immediately after removing the supraglottic airway device

• Presence of sore throat

  One hour after extubation

Study Arms (2)

Gastro-laryngeal tube Group (Group G)

ACTIVE COMPARATOR

Patients wear Gastro-laryngeal tube after receiving general anesthesia for biliopancreatic procedures

Device: Comparison of LMA Gastro Airway® and Gastro-Laryngeal Tube in patients who will undergo biliopancreatic procedures.

LMA Gastro Airway Group (Group L)

ACTIVE COMPARATOR

Patients wear LMA Gastro Airway® after receiving general anesthesia for biliopancreatic procedures

Device: Comparison of LMA Gastro Airway® and Gastro-Laryngeal Tube in patients who will undergo biliopancreatic procedures.

Interventions

Comparison of LMA Gastro Airway® and Gastro-Laryngeal Tube in patients who will undergo biliopancreatic procedures. DEVICE

comparing efficiency and complications of second generation airway devices which can use for gastrointestinally procedures

Gastro-laryngeal tube Group (Group G); LMA Gastro Airway Group (Group L)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA Physical Status 1-2
• Elective Procedures
• Weight 50-100 Kg

You may not qualify if:

• Laryngeal mask airway contraindications.
• Anesthesic drug allergies
• Height \<155 cm
• Body Mass index \> 35 kg/m2
• Alcohol or narcotic drug usage
• Restrictive or obstructive pulmonary diseases
• Hepatic cardiac or renal failure
• Psychotic problems
• Neurologic or cognitive deficiencies.
• Pregnancy
• Difficult airway or facial deformities
• Previous cervical surgery or cervical radiotherapy
• Previous esophagus surgery
• High risk of pulmonary aspiration

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: closed envelope.technique
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology And Reanimation Specialist

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: December 12, 2019
• Study Start: November 20, 2019
• Primary Completion: June 20, 2020
• Study Completion: July 10, 2020
• Last Updated: November 3, 2020

Record last verified: 2020-11

Locations

TU (1)