Clinical trial NCT04196582: LMA® Gastro Airway Versus Gastro-Laryngeal Tube in Endoscopic Retrograde Cholangiopancreatography
Official title: Comparison of LMA® Gastro Airway and Gastro-Laryngeal Tube in Endoscopic Retrograde Cholangiopancreatography: a Prospective Randomized Observational Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2019-12-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Oropharyngeal leak pressure
timeFrame: Intra-operative; after device insertion
measure: Endoscopist satisfaction analysis: score
timeFrame: Immediately after the procedure
measure: Leakage rate percentages
timeFrame: Intra-operative; after device insertion at first minute
Secondary outcomes:
measure: Hypopharyngeal/Esophageal Mucosal status
timeFrame: Within the first minute after the procedure is completed, while the duodenoscope is being removed while it passes through the esophagus and hypopharynx
measure: Blood staining on the device
timeFrame: Immediately after removing the supraglottic airway device
measure: Presence of sore throat
timeFrame: One hour after extubation
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
Study officials:
References: