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

Not Applicable

Completed

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

• Registration Number: NCT04196582
• Lead Sponsor: Bezmialem Vakif University

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.

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 Timeline

• Study Start: 2019-11-20
• Study First Submitted: 2019-11-25
• Study First Submitted QC: 2019-12-10
• Study First Posted: 2019-12-12
• Primary Completion: 2020-06-20
• Study Completion: 2020-07-10
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-01
• Last Update Posted: 2020-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gastro-laryngeal tube Group (Group G)	Comparison of LMA Gastro Airway® and Gastro-Laryngeal Tube in patients who will undergo biliopancreatic procedures.	Patients wear Gastro-laryngeal tube after receiving general anesthesia for biliopancreatic procedures
LMA Gastro Airway Group (Group L)	Comparison of LMA Gastro Airway® and Gastro-Laryngeal Tube in patients who will undergo biliopancreatic procedures.	Patients wear LMA Gastro Airway® after receiving general anesthesia for biliopancreatic procedures

Primary Outcome Measures

Name	Time	Method
Oropharyngeal leak pressure	Intra-operative; after device insertion	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.
Endoscopist satisfaction analysis: score	Immediately after the procedure	Endoscopist will score from 0 (worst) to 10 (best)
Leakage rate percentages	Intra-operative; after device insertion at first minute	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.

Secondary Outcome Measures

Name	Time	Method
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	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 \[grade 1- normal mucosa, grade 2- mild hyperemia, grade 3-severe hyperemia, grade 4-bloody gross hyperemia, grade 5- laceration\].
Blood staining on the device	Immediately after removing the supraglottic airway device	Whether there is blood on the supraglottic airway device or not
Presence of sore throat	One hour after extubation	Sore throat if present, was classified as mild, moderate or severe.

Trial Locations

Locations (1)

Bezmialem Vakif University; 🇹🇷 Istanbul, Turkey