endoscopic procedures in patients ASA 3 and above
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria were high-risk patients undergoing elective upper gastrointestinal endoscopic procedures and interventions with the need of general anesthesia. Airway management with LMA GastroTM, ASA status 3 or above, age 10 years and older, body weight above 30 kg. Patients fasted at least for 6 hours regarding solids and at least two hours for fluids other than water. It was our intention not to exclude any patients with oesophageal reflux, oesophageal strictures, cancer of the upper gastrointestinal tract or the stomach, achalasia, pancreatitis, upper GI bleeding, colitis, pyloric stenosis, morbid obesity etc.
Exclusion criteria
Exclusion criteria: Patients below the age of 10 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The combined outcome was defined as the feasibility to use the LMA GastroTM successfully for both, the endoscopic intervention and a sufficient airway management in the defined high-risk patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome parameters comprised (a) the ease to place the LMA GastroTM or any additional attempts to place the device, (b) the need of any alternative airway devices(i.e. endotracheal tube) in case of uncontrollable permanent airway leakage, (c) any form of dislocation associated to the endoscopic procedure, thus forcing the need for an alternative airway tool, other than the LMA GastroTM, (d) the incidence of pharyngeal bleeding during placement or after the removal of the LMA GastroTM, (e) any unwanted events during the endoscopic procedure with main focus on regurgitation, aspiration or hypoxia, (f) duration of the endoscopic procedure, (g) sore throat and/or hoarseness and (h) the comfort of advancing and operating the endoscope through the gastric channel rated by the attending endoscopist after the procedure via a 5 point Likert-type scale (0= not at all satisfied, 1= slightly satisfied, 2= moderately satisfied, 3= very satisfied, 4= completely satisfied). | — |
Countries
Germany
Contacts
Klinik für Anästhesiologie und IntensivmedizinUNIVERSITÄTSKLINIKUM FREIBURG