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Effectiveness of using a LMA Gastro Airway in patients when undergoing examination for gallbladder and pancreatic diseases

Comparison of the use of LMA Gastro Airway versus sedation and oxygen supplementation with nasal cannula in patients undergoing Endoscopic Retrograde Cholangiopancreatography: A Prospective Randomised control study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/06/054017
Enrollment
100
Registered
2023-06-16
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K87- Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Using a LMA Gastro Airway for Endoscopic Retrograde Cholangiopancreaticography: LMA Gastro Airway is a dedicated device to perform Endoscopic Retrograde Cholangiopancreaticography. We a

Sponsors

Sanjay Gandhi Post Graduate Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA I,II,III Elective procedure Patients with BMI less than 30 Adequate fasting

Exclusion criteria

Exclusion criteria: Patients unable (legally incompetent) or unwilling to give consent. ASA IV patients Patients with MODS and severe comorbidities Patients with BMI more than 30 Patients with height less than 150cms Patients in whom Supraglottic Devices are contraindicated. Patients with neurological or cognitive deficits, anticipated difficult airway(distorted head and neck anatomy, reduced mouth opening, history of head and neck cancers and radiotherapy, active GERD,COPD. Patients with increased risk of aspiration

Design outcomes

Primary

MeasureTime frame
Success rate of completion of Endoscopic Retrograde Cholangiopancreaticography through LMA Gastro Airway Timepoint: At 1 hour—

Secondary

MeasureTime frame
1.Success rate of insertion of LMA Gastro 2.Success rate of ERCP completion 3.Number of attempts 4.LMA Gastro insertion time Esophageal visualisation time 5.Comparison of vital parameters 6.Anaesthesiologist satisfaction analysis Gastroenterologist satisfaction analysis 7.Patient satisfaction analysis Post procedure recovery 8.Adverse eventsTimepoint: 1.Before insertion of endoscope(baseline) 2.At the end of procedure(at 1 hour)) 3.At the end of procedure(At 1 hour) 4.Time from picking up LMA Gastro to appearance of capnograph and time from insertion of endoscope to esophageal visualisation(baseline) 5.Throuhout the procedure(every 5 mins) 6.Immediately after completion of procedure(at 1hour) 7. Before discharge from PACU(4 hours) 8.Throughout the procedure and upto patient discharge(baseline and 72 hours)—

Countries

India

Contacts

Public ContactDr Meghna

Sanjay Gandhi Post Graduate Institute of medical science

suruchi0904@gmail.com9786025292

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026