Effectiveness of using a gastrolaryngeal tube in patients when undergoing examination for diseases of pancreas

Completed

• Conditions: Disease of biliary tract, unspecified. Ayurveda Condition: Biliary Tract and Pancreatic Diseases, (2) ICD-10 Condition: O||Medical and Surgical,

• Registration Number: CTRI/2021/06/034212
• Lead Sponsor: Sanjay Gandhi Post Graduate Institute of Medical Sciences

Brief Summary

Endoscopic Retrograde Cholangiopancreaticography (ERCP) is an diagnostic and therapeutic intervention in patients with diseases of biliary tract and pancrreas. Conventionally, it is performed with the patient in prone position under deep sedation which makes it uncomfortable and involves insertion of the endoscope multiple times and cause hypoxia. Gastrolaryngeal tube is a dedicated supraglottic airway device having separate channels for insertion of the endoscope and performing ventilation with an integrated bite block which help in performance of the procedure. The present study aims to compare the usage of Gastrolaryngeal tube with the standard institutional practice and recording the various associated parameters during the procedure

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-15
• Study Completion: 2022-05-26
• Last Update Posted: 2022-07-28

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Elective procedures Patient with BMI less than 30 Patients with height more than 150cms.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Success rate of completion of Endoscopic Retrograde Cholangiopancreaticography through Gastro-Laryngeal Tube	After the completion of the entire procedure of endoscopic retrograde cholangiopancreaticography

Secondary Outcome Measures

Name	Time	Method
Success rate of insertion of Gastrolaryngeal Tube
Success rate of procedures
Number of attempts
Gastrolaryngeal Tube insertion time and esophageal visualization time
Comparison of vital parameters (saturation and hemodynamic)
Patient’s satisfaction analysis and post procedure recovery along with incidence of sore throat, hoarseness, dysphagia, dysphonia.
Intra-procedure and post procedure adverse events
Duration of time until Aldrete recovery score ≥9
Total amount of propofol consumed

Trial Locations

Locations (1)

Sanjay Gandhi Post Graduate Institute of Medical Sciences; 🇮🇳 Lucknow, UTTAR PRADESH, India

Sanjay Gandhi Post Graduate Institute of Medical Sciences

🇮🇳Lucknow, UTTAR PRADESH, India

Dr Rudrashish Haldar

Principal investigator

9256543256

rudrashish@yahoo.com