Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: LMA GastroT Cuff PilotTM Airway: The patients undergoing the ERCP procedures will be anesthetized with standard technique without muscle relaxation and LMA gastro. airway will be insert
Sponsors
All India Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients undergoing therapeutic ERCP for biliary or pancreatic interventions. With anticipated procedure time >30min 2. Age 18-70 years, weight > 30 kg, Height > 155 cm AND One of the following criteria a) ASA status 3 or more b) BMI 30 kg/m2 or more c) STOP BANG score > 3
Exclusion criteria
Exclusion criteria: 1. Refusal of consent. 2.Reduced mouth opening (inter-incisor distance 3.Propofol allergy 4. altered consciousness (GCS 5. Fasting period of 6. Active gastroesophageal reflux disease. 7. Clinically detectable ascites 8. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the SAREs with LMA Gastro and sedation during ERCP procedures.Timepoint: oxygen desaturation (SpO2 92%), laryngospasm, pulmonary aspiration, bronchospasm, need of maneuvers (nasal airway, oral airway, chin lift, jaw thrust, or bag max ventilation), sedation-related procedure interruption, hypotension and cardiac arrhythmia or termination. The monitoring will be continuously done during the procedure. The recordings will be done baseline and every 10 minutes thereafter | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Time from endoscopy completion to patient wheeled out 2. Recovery to MAS 9 3. Therapeutic success 4. Procedure-related adverse events (PRAEs) classified according to the American Society for Gastrointestinal Endoscopy lexicon of adverse events 5.The device insertion times, emergence and recovery times will be measured using a stop watch by an independent anesthesiologist who will not be a part of the study. 6. Gastroenterologist satisfaction 7.Incidence of device insertion failure. 8. Incidence of airway device displacement after positioning. 9. Need for endotracheal intubation 10. Incidence of hypotension, bradycardia, pharyngeal bleed, gastroesophageal reflux and pulmonary aspiration, PONV and post-procedure sore throat. Timepoint: The sore throat will be recorded at 30 min and 2 hours after the procedure. PONV will be recorded for two hours on patient complaints. Items 1,2,3,4,5,6,7,8,9 will be recorded once during the procedure mentioned. | — |
Countries
India
Contacts
Public ContactAnju Gupta
AIIMS
Outcome results
None listed