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A clinical trial to compare the performance of two devices used to facilitate respiration in anaesthetised patients

A prospective randomized controlled study to compare two supraglottic airway devices LMA-protectorTM and LMA-prosealTM in anaesthetised patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/10/046532
Enrollment
84
Registered
2022-10-17
Start date
Unknown
Completion date
Unknown
Last updated
2022-11-21

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: LMA protector vs LMA Proseal: LMA protector or LMA Proseal is inserted to secure the airway to facilitate respiration under anesthesia. Total duration will for insertion will be timed

Sponsors

Lady Hardinge Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA grade !,2 weight >30Kg Elective surgery under general anaesthesia

Exclusion criteria

Exclusion criteria: Upper airway anatomical or pathological abnormality, Known or predicted difficult airway Risk of aspiration (full stomach, hiatus hernia, gastroesophageal reflux etc.) High risk surgeries with risk of aspiration (e.g Gut surgeries) Emergency surgeries Head & neck surgeries

Design outcomes

Primary

MeasureTime frame
Oropharyngeal leak pressure in LMA Proseal and LMA ProtectorTimepoint: baseline, 2 hours and 24 hours after completion of surgery

Secondary

MeasureTime frame
1. successful insertion at 1st attempt in both groups 2. no of manipulations required in both groups 3. insertion time in both groups 4. ease of nasogastric tube insertion via gastric port of the two devices 5. post operative complications like sore throat, hoarseness, dysphagiaTimepoint: 1, 2, 3, 4: after successful insertion of the devise 5. 2 and 24 hours postoperatively

Countries

India

Contacts

Public ContactDr Garima Agrawal

Lady Hardinge Medical College

garima2396@gmail.com8826640501

Outcome results

None listed

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