Clinical trial comparing the advantage of use of i- gel over ProSeal airway device in children

Comparison of i-gel with ProSeal laryngeal mask airway for airway management in paediatric patients

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/08/003898

Enrollment

100

Registered

2013-08-13

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- peadiatric patient between age 2- 6 years scheduled for short duration elective surgeries

Interventions

Intervention1: i-gel: Comparison of i-gel with ProSeal laryngeal mask airway for airway management in paediatric patients Control Intervention1: ProSeal laryngeal mask airway: Comparison of i-gel with

Eligibility

Inclusion criteria

Inclusion criteria: 1.American Society of Anesthesiologist (ASA) physical status I/II of either sex 2.Age group of 2-6 years 3.Weight between 10-30 kg 4.Scheduled for short duration elective surgeries requiring general anaesthesia with controlled ventilation

Exclusion criteria

Exclusion criteria: 1.Upper respiratory tract infection 2.Anticipated difficult airway 3.Children at increased risk of aspiration - Gastro esophageal reflux disease, non fasting status 4.Cardiorespiratory or cerebrovascular disease

Design outcomes

Primary

Measure	Time frame
Oropharyngeal seal pressureTimepoint: just after insertion of the airway	—

Secondary

Measure	Time frame
Number of Attempts Insertion time (seconds) Ease of insertion of Supraglottic airway device Ease of orogastric tube insertion Quality of the initial airway Malposition Fibreoptic grading Haemodynamic parameter including Pulse rate,Systolic blood pressure,Diastolic blood pressure,mean arterial pressure Ventilatory parameter:SpO2 % EtCO2 (mmHg),Peak airway pressure(cm/H2O),Mean airway pressure(cm/H2O),Resistance( cm H2O/L/sec),Compliance L/cm H2O,Minute ventilation(L/min) Timepoint: hemodynamic parameters baseline , after induction,2 mins and 5 mins after insertion , after removal of the device , ventilatory parameters at 2 minutes and 5 minutes after insertion of the device	—

Measure

Time frame

Number of Attempts Insertion time (seconds) Ease of insertion of Supraglottic airway device Ease of orogastric tube insertion Quality of the initial airway Malposition Fibreoptic grading Haemodynamic parameter including Pulse rate,Systolic blood pressure,Diastolic blood pressure,mean arterial pressure Ventilatory parameter:SpO2 % EtCO2 (mmHg),Peak airway pressure(cm/H2O),Mean airway pressure(cm/H2O),Resistance( cm H2O/L/sec),Compliance L/cm H2O,Minute ventilation(L/min) Timepoint: hemodynamic parameters baseline , after induction,2 mins and 5 mins after insertion , after removal of the device , ventilatory parameters at 2 minutes and 5 minutes after insertion of the device

—

Countries

India

Contacts

Public ContactNIRUPA R

GOVERNMENT MEDICAL COLLEGE HOSPITAL , SECTOR -32 , CHANDIGARH

dr_sgombar@rediffmail.com9646121520

Outcome results

None listed

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