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To Compare the Baska Mask and i-Gel Against Proseal Laryngeal Mask Airway In Adult Subjects and Find Out the Better Characteristics for Use in Anesthetised patients- A Prospective Randomized Study

A Comparison Of Baska Mask and i-Gel Against Proseal Laryngeal Mask Airway In Adult Subjects - A Prospective Randomized Study - SADSITE

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/06/054558
Enrollment
240
Registered
2023-06-30
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

None listed

Interventions

Intervention1: Insertion of Supraglottic Airway Device (SAD): Correct placement of the supraglottic airway device per orally with upto maximum two additional attempts after induction of anesthesia for

Sponsors

Anmol Singh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with the understated criteria were included in the study 1. Physical status based on American Society of Anaesthesiologists Class 1 and Class 2. 2. Mallampatti Scoring of MP Grade 1, 2 and 3. 3. Patients aged 18 - 60 years. 4. Normal coagulation profile. 5. Surgeries requiring general anaesthesia of duration within 2 hours. 6. Minimum fasting status of 8 hours for solids and 6 hours for liquids.

Exclusion criteria

Exclusion criteria: Patients with the understated criteria were excluded out of the study 1. Age 60 years, non-consenting, patients 2. Deranged coagulation profile or platelet counts 3. Patients with uncontrolled co-existing systemic or metabolic diseases. However, their controlled counterparts (considered as ASA II), shall be considered. 4. Major open abdominal surgery or surgeries that share the airway with surgical field. 5. Any gross anatomical airway/neck abnormalities 6. Patients with any anticipatory contributory factors that may exponentially elevate the susceptibility of aspiration (Hiatal Hernia, GERD)

Design outcomes

Primary

MeasureTime frame
The ease and efficacy of placement was evaluated on a.No. of attempts b.Time for successful insertion max 2 mins i.Time of insertion measured with Casio HS80TW1DF S055 stopwatch 1000th second accuracy ii.Start of timer defined as operator picking up the prelubricated SAD iii.End of measurement was defined as bilateral chest rise and square wave capnograph trace. It will be followed by auscultation of trachea for leaks c.Additional manoeuvres required d.User rated ease of insertion 0to10Timepoint: Only once after induction of anesthesia before skin incision

Secondary

MeasureTime frame
Perioperative complications a. Incidents of laryngeal spasm (if seen or absent) b. Incidents of laryngeal injury (assessed by presence of blood staining on the SAD) c. Incidents of aspiration (assessed by a binary 0 or 1 scoring system on presence or absence of food staining on the SAD)Timepoint: At induction & at extubation;Postoperative laryngopharyngeal morbidity (after 24 hours of surgery) a) Soreness/pain in throat (assessed using Visual Analogue Pain Scale b) Difficulty in swallowing (assessed using a binary 0 or 1 scoring for presence or absence) c) Difficulty in speaking (assessed using a binary 0 or 1 scoring for presence or absence)Timepoint: 24 hours after extubation

Countries

India

Contacts

Public ContactAnmol Singh

Adesh Institute of Medical Sciences and Research

dranmolsinghchd@gmail.com9814019104

Outcome results

None listed

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