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

NCT ID: NCT04196582

Last Updated: 2020-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-20
• Study Completion Date: 2020-07-10

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Gastro-laryngeal tube Group (Group G)

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

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

LMA Gastro Airway Group (Group L)

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bezmialem Vakif University

OTHER

Sponsor Role: lead

Responsible Party

Harun UYSAL

Anesthesiology And Reanimation Specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Bezmialem Vakif University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Bezmialem Vakif University

Identifier Type: -

Identifier Source: org_study_id