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NCT Number: NCT04196582

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

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

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

Primary outcomes

  1. Oropharyngeal leak pressure

    Time frame: 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.

  2. Endoscopist satisfaction analysis: score

    Time frame: Immediately after the procedure

    Endoscopist will score from 0 (worst) to 10 (best)

  3. Leakage rate percentages

    Time frame: 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 outcomes

  1. Hypopharyngeal/Esophageal Mucosal status

    Time frame: 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].

  2. Blood staining on the device

    Time frame: Immediately after removing the supraglottic airway device

    Whether there is blood on the supraglottic airway device or not

  3. Presence of sore throat

    Time frame: One hour after extubation

    Sore throat if present, was classified as mild, moderate or severe.

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 12, 2019
Registry last updated
Nov 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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