Comparison of the clinical performance of I gel and Ambu Aura Gain supra glottic airway devices in paediatric patients under controlled ventilation.

Not yet recruiting

Conditions: Bilateral inguinal hernia, withoutobstruction or gangrene, (2) ICD-10 Condition: L029||Cutaneous abscess, furuncle and carbuncle, unspecified,

Registration Number: CTRI/2019/05/019126

Lead Sponsor: Ashka V Surve

Brief Summary: | |

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|As newer pediatric sized supra-glottic airway devices like I-gel and Ambu Aura Gain are available for use in clinical practice in children. It is important to evaluate their clinical performance and safety to establish superiority or equivalence to the existing devices. So, we choose this study to evaluate and compare overall performance of I-gel versus Ambu Aura Gain in pediatric patients undergoing general anesthesia. To compare the clinical performance of I gel with Ambu Aura Gain in pediatric population for providing adequate airway seal under controlled mechanical ventilation under general anesthesia.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

1.Patients age group 3-10 years 2.Either gender 3.Weight 10-35 kg 4.ASA physical status I/II 5.Patients admitted in SSGH and posted for 6.Elective surgeries requiring general anesthesia ( abdominal surgeries, upper limb surgeries, lower limb surgeries, head and neck surgeries etc.

Exclusion Criteria

1.Patient with risk factors of difficult airway (mouth opening of < 2cm, mallampatti class III and IV, limited neck extension, history of previous difficult tracheal intubation).
2.Patients with recent upper respiratory tract infection.
3.Patient with any known pulmonary and cardiovascular diseases.
4.Patient with any conditions that increase the risk of gastro esophageal regurgitation.
5.Parents or guardian not willing for participation.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The oropharyngeal seal pressure of I-gel is higher than Ambu Aura Gain in their individual studies. Whereas insertion of Ambu aura gain is faster than I-Gel.	at 5 minute after insertion of the device, oropharyngeal leak pressure will be noted.

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes are haemodynamic and respiratory parameters.	These secondary outcomes are observed throughout the duration of surgery.

Trial Locations

Locations (1): SSG Hospital and GOvernment Medical COllege Baroda
🇮🇳
Vadodara, GUJARAT, India
SSG Hospital and GOvernment Medical COllege Baroda
🇮🇳Vadodara, GUJARAT, India
ashka surve
Principal investigator
9033694150
ashkasurve@gmail.com