Success rate of upper gastrointestinal endoscope insertion directly into the oesophagus through a dedicated channel in the laryngeal mask airway (LMA) called the LMA GASTRO (Trademark)

Not Applicable

Completed

• Conditions: pper gastrointestinal endoscopic procedures; Upper gastrointestinal endoscopic procedures; Anaesthesiology - Anaesthetics; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12616001464459
• Lead Sponsor: Royal Hobart Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-20
• Study Completion: 2017-03-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 292

Inclusion Criteria

ASA I –II, older than 18 years of age, fasted at least 6 hours for solids and 2 hours for clear liquids, undergoing elective upper gastro-intestinal endoscopic procedures requiring deep sedation

Exclusion Criteria

Patients at significant risk of pulmonary aspiration will be excluded based on anaesthetic clinical judgment after performing a clinical risk assessment. The clinical risk assessment will be performed based on patient history (focussing particularly on risk factors for aspiration) and physical examination to establish the risk of aspiration prior to enrolment. Possible risk factors for aspiration include:
1. Increased gastric content: delayed gastric emptying including lap band in situ, gastric hyper secretion, overfeeding, lack of fasting (less than six hours solids and two hours for clear fluid).
2. Increased tendency to regurgitate: symptomatic or uncontrolled gastro-oesophageal reflux, oesophageal strictures, Zenker Diverticulum, achalasia.
3. Laryngeal incompetence: Emergency surgery, head injuries, cerebral infarct, neuromuscular disorders (Parkinson’s disease, Gullian Barre), muscular dystrophies (cerebral palsy, cranial neuropathies)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Endoscopic insertion success rate (binary outcome). The number of endoscopic attempts will be noted and considered a failure if the insertion was not successful in three attempts [This will be recorded after LMA GASTRO (Trademark) insertion with the insertion of the endoscope]