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A study comparing how well three different airway devices i-gel, Blockbuster, and Ambu Aura LMA help patients breathe during short surgeries.

Comparative study to determine the efficacy of i-gel, BlockBuster, and Ambu Aura as ventilatory devices in short surgical procedures. - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/082577
Enrollment
90
Registered
2025-03-18
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Health Condition 1: K00-K95- Diseases of the digestive system Health Condition 2: H60-H95- Diseases of the ear and mastoid process Health Condition 3: H00-H59- Diseases of the eye and adnexa Health Condition 4: N00-N99- Diseases of the genitourinary system Health Condition 5: N00-N99- Diseases of the genitourinary system Health Condition 6: M00-M99- Diseases of the musculoskeletal system and connective tissue

Interventions

Intervention1: i-gel: The study population is divided into 3 groups of 30 patients each. Group I used i-gel as a ventilatory device
Group B used BlockBuster as a ventilatory device
and Group A used Ambu Aura as a ventilatory device instead of traditional endotracheal intubation. In group I using i-gel, oropharyngeal leak pressure and other parameters such as vitals, side effects
and Group A used Ambu Aura as a ventilatory device instead of traditional endotracheal intubation. In group B using BlockBuster, oropharyngeal leak pressure and other parameters such as vitals, side e
and Group A used Ambu Aura as a ventilatory device instead of traditional endotracheal intubation. In group A using Ambu Aura, oropharyngeal leak pressure and other parameters such as vitals, side eff

Sponsors

Dr. Ashish Bisht
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients giving informed written consent for participation in the study. 2.Patients posted for short surgeries (less than 90mins) under general anesthesia. 3.Age of the patient between 18-65 of either sex. 4.Patients belonging to American Society of Anesthesiologists- physical status I or II. 5.Patients belonging to Modified Mallampati class I and II.

Exclusion criteria

Exclusion criteria: 1.Patients with predicted difficult airway such as mouth opening less than 2 cm, (oropharynx, larynx) pathology. 2.Patients with head injury, psychiatric disorder, respiratory tract, endocrine disorder, patients with risk of regurgitation such as gastroesophageal reflux disease, hiatus hernia, esophageal varices, pregnant patient etc. 3.Patient who are obese (BMI more than 35 kg/m2)

Design outcomes

Primary

MeasureTime frame
To compare the oropharyngeal leak pressure for providing airway seal pressure of i-gel, BlockBuster, and Ambu Aura.Timepoint: After 5 minutes of positioning and fixation of the device, oropharyngeal leak pressure will be assessed. It will be measured by palpable or audible leak of gas in suprasternal notch and auscultation of epigastrium after closing the expiratory valve of the circle system to 30 cm of H2O at a fixed gas flow (only O2) of 6 L/min and airway pressure at steady state noted on the visual pressure gauge included in modern anesthesia machines. We will not permit it to exceed 30 cm of H2O.

Secondary

MeasureTime frame
To compare effective airway insertion time, number of insertions attempts and ease of insertion of device and gastric tube.Timepoint: ;To compare hemodynamics & ventilatory parameters, intraoperative & post-operative complications (oral trauma, sore throat, dyspnea etc.) during use of the devices, if anyTimepoint: Vital parameters like pulse rate, blood pressure, SpO2, EtCO2, & ventilator parameters will be noted at baseline (0 minutes) after induction of anesthesia, after insertion, 10 minutes after insertion, & immediately after removal of the device & after completion of surgery.

Countries

India

Contacts

Public ContactDr Geeta Bandari

Government medical college, Haldwani

bhandari_geetantl@rediffmail.com8650655556

Outcome results

None listed

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