Health Condition 1: K805- Calculus of bile duct without cholangitis or cholecystitis
Conditions
Interventions
Control Intervention1: Gastro� Laryngeal Mask Airway®: The Gastro� LMA® is a novel device with the ability to facilitate direct endoscopic access via the integrated endoscopic channel, as well a
Sponsors
JSSAHER
Eligibility
Inclusion criteria
Inclusion criteria: All patients, 18-65 years of age undergoing ERCP with ASA physical status I, II or II
Exclusion criteria
Exclusion criteria: i) Patients with propofol / egg allergy. ii) Patients with any history or predictors of difficult airway. iii) Patients with increased aspiration risk. iv) Emergency cases (like cholangitis, acute bleeding). v) Patients with abnormal head/neck morphology thus preventing the placement of LMA Gastro device. vi) Patients with head and neck surgery or radiation therapy, making the placement of LMA Gastro device difficult. vii) Pregnant women. viii) Patient refusal for the study procedure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To record the number of intra-procedural cardiorespiratory events, namely hypoxia, hypercapnia, arrhythmias, hypotension.Timepoint: From start of intravenous sedation till completion of ERCP procedure and patient has been assessed to be stable. | — |
Secondary
| Measure | Time frame |
|---|---|
| i) To record the number of attempts required to introduce LMA® Gastroâ?¢, and the attempts required to pass endoscope through LMA Gastro. ii) To observe for post-procedure complications, immediate post-procedure sore throat. iii) To record the amount of propofol required to maintain adequate sedation during the procedure. iv) To assess gastroenterologist satisfaction with the LMA® Gastroâ?¢ device.Timepoint: From time of placement of the Gastro LMA till 2hrs post procedure. | — |
Countries
India
Contacts
Public ContactDr Archana KN
JSSAHER
Outcome results
None listed