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A Comparison of oropharyngeal leak pressure between LMA Protector and LMA Supreme

A Comparative study of Oropharyngeal leak pressure by LMA ProtectorTM with cuff pilot vs LMA SupremeTM in paralyzed patients â?? A prospective randomized clinical study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/06/033987
Enrollment
62
Registered
2021-06-04
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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 ProtectorTM with cuff pilot: LMA ProtectorTM with cuff pilot is the most advanced and newest SGA with a good pharyngeal seal at higher oropharyngeal leak pressure compare to LMA Sup

Sponsors

Medical College And SSG Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients in age group 18 - 70 years Either gender Weight 30 â?? 70 kg ASA physical status I/II Patients posted for elective surgeries requiring general anaesthesia

Exclusion criteria

Exclusion criteria: Patient with predicted difficult airway (Mouth opening of H/O previous difficult tracheal intubation. Patients with recent upper respiratory tract infection. Patients with any oropharyngeal pathology. Patient with any known pulmonary disease and cardiovascular diseases. Obese patients with BMI >30 kg/m2 Patient with any conditions that increase the risk of gastro oesophageal regurgitation. H/O allergy to Latex or to any drugs used in protocol or any other allergic conditions. Patients not willing for participation.

Design outcomes

Primary

MeasureTime frame
To compare the Oropharyngeal leak pressure (OLP) between LMA Protectorâ?¢ Cuff Pilot and LMA Supremeâ?¢.Timepoint: After SGA insertion 15 min 30 min 45 min 60 min 75 min 90 min 105 min

Secondary

MeasureTime frame
2.To compare the hemodynamic parameters like HR, MAP, SpO2, EtCO2.Timepoint: Measure hemodynamic parameters: Baseline After giving premedication After induction 3 min 5 min 7 min Every 10 min Before reversal Before device removal 10min after device removal;3.To observe complications like trauma, sore throat, dysphagia, dysphoniaTimepoint: They will be observed following device removal and 24 hours later. These include- Trauma to mouth, lip, tongue blood staining at removal sore throat Dysphagia Dysphonia (For both the devices);To compare the insertion characteristics in terms of: Insertion time Number of attempts Ease of insertion Suprasternal notch test Ease of gastric tube insertion Timepoint: a.Insertion time (seconds): It is defined as the time from picking up of the device to the presence of CO2 trace on capnograph. b. Number of attempts: c. Ease of insertion: It will be assessed using the following scale.1 d. Ease of gastric tube insertion â?? no of attempts e. Suprasternal notch test: YES or NO

Countries

India

Contacts

Public ContactDr Kavita Lalchandani

Medical College And S.S.G.Hospital, Vadodara.

lalchandanikavita@yahoo.co.in9274586809

Outcome results

None listed

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