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â??Comparison of two airway devices placed above the voice box under vision guidance for the purpose of administrating anesthesia

To determine the clinical performance of Laryngeal Mask Airway Pro-seal when compared with Laryngeal Mask Airway Protector using video laryngoscope guided insertion technique in patient under General Anesthesia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/12/048423
Enrollment
68
Registered
2022-12-23
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

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: Laryngeal Mask Airway Pro-seal and Laryngeal Mask Airway Protector: Video laryngoscope guided insertion - used once at the time of insertion of LMA Control Intervention1: Laryngeal Mask

Sponsors

Pondicherry Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients belonging to American Society of Anesthesiologists grade I or II 2. Age: above 18yrs and below 65yrs 3. Mouth opening > 5cm 4. Patients posted for short surgical procedures < 3hours

Exclusion criteria

Exclusion criteria: 1.Emergency surgeries 2.Presence of an upper airway anatomic variation or pathology 3. Surgery requiring lateral or prone position 4. Body mass index greater than 30 kg/m2 5. Patients having aspiration tendency(full stomach, history of stomach surgery, gastroesophageal reflux, hiatal hernia, sore throat, upper respiratory airway infections).

Design outcomes

Primary

MeasureTime frame
To compare oropharyngeal leak pressure (OLP) of LMA Pro-seal and LMA protector when inserted under vision guidance using video laryngoscope.Timepoint: At 10min—

Secondary

MeasureTime frame
1. To assess the ease and accuracy of device insertion, ease of gastric tube placement. 2. To detect the hemodynamic responses induced by airway insertion [blood pressure, heart rate, oxygen saturation and end-tidal carbon dioxide (EtCO2)]. 3. To detect the incidence of postoperative complications such as the presence of blood on the device and severity of sore throat.Timepoint: 1.Once LMA is positioned correctly gastric tube is placed. 2.Hemodynamic responses recorded at pre induction , post induction , 3min , 5min , 10min 3.Post operative complications assessed within 3hrs—

Countries

India

Contacts

Public ContactVidya M V

Pondicherry Institute of Medical Sciences

drmvvidya@gmail.com9585550838

Outcome results

None listed

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