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Comparison of clinical peroformance of two supraglottic airway devices

Comparison of BrimacombeScore and first-attempt success rate of Ambu AuraGain and I-gel in anaesthetised adult patients: A Prospective open label study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/08/055942
Enrollment
96
Registered
2023-08-01
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

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: Insertion of I Gel: I Gel will be inserted after induction of Anaesthesia and will be used as an aid to intubation.Igel will be removed after intubation. Duration of intervention 10 min

Sponsors

AIIMS Kalyani
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Age 18 years â?? 60 years of age 2) Scheduled for elective surgeries requiring general anesthesia 3) Scheduled surgery 4) American Society of Anesthesiology (ASA) Physical Status I-II 5) BMI 6) Mallampati I-II 7) Able to bite upper lip via Upper Lip Bite Test 8) Inter-incisor distance > 2.5cm 9) Thyromental distance > 6cm 10) Full range of motion in the neck

Exclusion criteria

Exclusion criteria: 1)Inadequate fasting (Liquid only diet 2) High risk of regurgitation 3) Exhibits signs of respiratory tract pathology (including a sore throat preoperatively) 4) Airway pathology/facial abnormality 5) Has been diagnosed with/exhibits any mental neurological disorder/disease/condition that would prevent participation in the study in the opinion of the investigator. 6) Pregnant females.

Design outcomes

Primary

MeasureTime frame
1.To compare the Brimacombe score of Ambu AuraGain and I-gel in anaesthetised adult patients 2.To compare the first attempt success of Ambu AuraGain and I-gel in anaesthetised adult patientsTimepoint: First attempt success will be assessed at the time of insertion and Brimcombe score will be assessed after insertion while attemting fibreoptic guided intubation.

Secondary

MeasureTime frame
To compare Oropharyngeal leak pressure of Ambu AuraGain & I-gel in anaesthetised adult patients To compare Ease of gastric tube insertion Ambu AuraGain & I-gel in anaesthetised adult patients To compare Time taken for Endotracheal tube (ETT) insertion ofAmbu AuraGain & I-gel in anaesthetised adult patients To compare Adverse Effects/Complications ofAmbu AuraGain & I-gel in anaesthetized adult patientsTimepoint: Immediately after insertion of the supraglottic device. After surgery in the immediate postoperative period.

Countries

India

Contacts

Public ContactAnjum Naz

AIIMS Kalyani

dranjumnaz75@gmail.com

Outcome results

None listed

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