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

Bezmialem Vakif University

Status: Completed

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04196582

Bezmialem Vakif University

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Gastro-laryngeal tube Group (Group G)

Active Comparator group

Description:

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

Treatment:

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 group

Description:

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

Treatment:

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