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Comparison of bougie guided insertion method of LMA Protector with the conventional method

Comparison of Gum Elastic Bougie guided insertion of LMA Protector Versus the conventional method in achieving oesophgeal patency; a prospective randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/09/045899
Enrollment
132
Registered
2022-09-26
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Insertion of LMA Protector by Gum Elastic Bougie: The drain tube of LMA Protector is primed with a well-lubricated bougie with its straight end protruding through its distal end, leavi

Sponsors

Maulana Azad Medical College Associated Lok Nayak Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18-75 years 2. ASA grade I & II 3. Anticipated duration of surgery less than 2 hours

Exclusion criteria

Exclusion criteria: 1. BMI more than 35 kg/m2 2. Presence of predictors for difficult airway 3. Surgery requiring patient positioning in prone or lateral decubitus 4.Patient at risk of aspiration

Design outcomes

Primary

MeasureTime frame
adequacy of aligment of tip of the drain tube of LMA Protector with the upper oesophageal opening by the ability to pass fibrescopeTimepoint: baseline—

Secondary

MeasureTime frame
Ease of insertion of deviceTimepoint: 0 day;FOB view Grade through LMA ProtectorTimepoint: 0 day;Haemodynamic changes after insertion of deviceTimepoint: 5, 10 and 15 minutes after device insertion;Maneuvers for facilitating insertion of LMA ProtectorTimepoint: 0day;Number of attempts taken for successful insertion of LMA ProtectorTimepoint: 0 day;Postoperative Sore throatTimepoint: 2, 4 and 6 hours aftersurgery;time taken for sucessful insertion of LMA ProtectorTimepoint: 0 day—

Countries

India

Contacts

Public ContactDr Sukhyanti Kerai

Maulana Azad Medical College

drsukhi25@gmail.com9968527122

Outcome results

None listed

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