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A study comparing two types of airway devices air-q and I-gel used to help children breathe safely during general anaesthesia

A Randomised comparative Study to evaluate oropharyngeal leak pressure of Self – pressurized Air-Q versus I-Gel Laryngeal Airway in pediatrict patients under general anaesthesia at SMS Medical College Jaipur - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097055
Enrollment
70
Registered
2025-11-07
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Health Condition 1: K402- Bilateral inguinal hernia, withoutobstruction or gangrene Health Condition 2: N29- Other disorders of kidney and ureter in diseases classified elsewhere Health Condition 3: K318- Other specified diseases of stomach and duodenum

Interventions

Intervention1: I-gel laryngeal airway: I-gel is a second generation supraglottic airway,provide an anatomical seal without cuff inflation,standard insertion and monitoring protocol will be followed Co

Sponsors

SMS MEDICAL COLLEGE AND ATTACHED HOSPITAL, JAIPUR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Parent/guardian willing to provide consent for participation. Patients of either sex. age 0-5 years weight -0-25 kg ASA GRADE I and II Undergoing elective surgery in supine position requiring general anaesthesia.

Exclusion criteria

Exclusion criteria: Abnormal airway anatomy assessed by – inadequate mouth opening, micrognathia, thyromental distance, and submental compliance, intra oral growth. Patient with cardiopulmonary disease Severe gastrointestinal reflux History of upper respiratory tract infection in previous 14 days. Syndromic children with difficult airway, intraoral pathology.

Design outcomes

Primary

MeasureTime frame
Oropharyngeal leak pressure of Self -pressurised Air-Q and I-Gel laryngeal airway measured in paediatric patients under general anaesthesiaTimepoint: 1.Immediately after insertion of the device 2.After 5 minutes post insertion 3.At the end of surgery befor device removal—

Secondary

MeasureTime frame
To evaluate and compare fiber optic view of larynx between two study groups. To evaluate and compare post-operative complications (laryngospasm, sore throat, dysphagia, blood staining of device) between two study groups. To evaluate and compare hemodynamic changes between two study groups.Timepoint: Time (in min) HR(bpm) BP(mmHG) MAP(mmHG) SpO2(%) Baseline After Induction After Insertion of LMA 3 mins after insertion of LMA 5 mins after insertion of LMA 10 mins after insertion of LMA 15 mins after insertion of LMA 20 mins after insertion of LMA 30 mins after insertion of LMA 40 mins after insertion of LMA 50 mins after insertion of LMA 60 mins after insertion of LMA Time (in min) HR(bpm) BP(mmHG) MAP(mmHG) SpO2(%) Baseline After Induction After Insertion of LMA 3 mins after insertion of LMA 5 mins after insertion of LMA 10 mins after insertion of LMA 15 mins after insertion of LMA 20 mins after insertion of LMA 30 mins after insertion of LMA 40 mins after insertion of LMA 50 mins after insertion of LMA 60 mins after insertion of LMA—

Countries

India

Contacts

Public ContactDr Sapna Sharma

SMS MEDICAL COLLEGE, JAIPUR

neelam_dogra24@yahoo.com9928709289

Outcome results

None listed

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