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

Comparison of LMA® Gastro Airway and Gastro-Laryngeal Tube in Endoscopic Retrograde Cholangiopancreatography: a Prospective Randomized Observational Trial

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.

Study Overview

• Status: Completed
• Conditions: Airway Complication of Anesthesia; Airway Aspiration; Complication of Anesthesia; Esophagus Injury; Supraglottic Airway Efficiency; Endoscopic Ergonomics; ERCP Airway Management
• Intervention / Treatment: Device: Comparison of LMA Gastro Airway® and Gastro-Laryngeal Tube in patients who will undergo biliopancreatic procedures.

Detailed Description

Supraglottic airway (SGA) devices are produced for avoiding endotracheal intubation for anesthesic interventions. Second generation SGA's like GLT and LMA® Gastro airway are using for endoscopic biliopancreatic procedures. Both of them have an airway canal and endoscopic canal. Although they can use for same reason, their designs are different. So, their airway securities, endoscopic manipulations and complications, would be different.

This study planned as single blind. American Society of Anesthesiologists (ASA) Physical status 1-2 100 patients which will be take endoscopic retrograde cholangiopancreatography (ERCP) included. The study starts after randomization and ends after discharge from the recovery room. All patients will be monitorised for hemodynamic parameters. Depth of anesthesia will be provided by bispectral index (BIS) monitoring. After anesthesia induction SGA will placed by an experienced anesthesiologist. Bilateral chest movements and auscultation, capnogram graphy and oropharyngeal leak pressure test will be used for confirmation of placement. After procedure endoscopist will take pictures of esophagus and hypopharynx. After extubation and sufficient consciousness and breathing of patient, patients will be transferred to post-anaesthesia care unit (PACU). Vital parameters will continue to monitoring in PACU. Patients will be discharge as usual with an Aldrete score ≥ 9.

Data will be collected during the procedure and in recovery room. Data will be stored in electronic database without mention to patient's name.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Bezmialem Vakif University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Gastro-laryngeal tube Group (Group G); 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.; comparing efficiency and complications of second generation airway devices which can use for gastrointestinally procedures
Active Comparator: LMA Gastro Airway Group (Group L); 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.; comparing efficiency and complications of second generation airway devices which can use for gastrointestinally procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypopharyngeal/Esophageal Mucosal status	Number of patients with hyperemia, laceration (while extubating patient, endoscopist will take pictures of esophagus for if there is any mucosal damage). Esophageal and hypopharyngeal mucosal damage was determined in 5 grades by a visual mucosal damage scoring system [grade 1- normal mucosa, grade 2- mild hyperemia, grade 3-severe hyperemia, grade 4-bloody gross hyperemia, grade 5- laceration].	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	Whether there is blood on the supraglottic airway device or not	Immediately after removing the supraglottic airway device
Presence of sore throat	Sore throat if present, was classified as mild, moderate or severe.	One hour after extubation

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2019
• Primary Completion (Actual): June 20, 2020
• Study Completion (Actual): July 10, 2020

Study Registration Dates

• First Submitted: November 25, 2019
• First Submitted That Met QC Criteria: December 10, 2019
• First Posted (Actual): December 12, 2019

Study Record Updates

• Last Update Posted (Actual): November 3, 2020
• Last Update Submitted That Met QC Criteria: November 1, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: ERCP; Gastro-laryngeal tube; airway complications; LMA gastro airway
• Other Study ID Numbers: Bezmialem Vakif University

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No