Comparison between Two supraglottic airway devices in anaesthetized patients on spontaneous ventilation during daycare proceduresventilation during daycare procedures

Comparison between LMA Pro Seal and I-gel airway in anaesthetized patients on spontaneous ventilation during daycare procedures - NA

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/09/028146

Enrollment

Registered

2020-09-29

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: Z768- Persons encountering health services in other specified circumstances

Interventions

Control Intervention1: LMA Pro Seal airway: supraglottic device use in anaesthetized patients Control Intervention2: I-Gel airway: Supraglottic Airway device use in anaesthetized patients

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients aged between 15-60 years 2. ASA I-II 3.Body mass index (BMI) between 20-30 kg/m2 4.Scheduled for elective surgeries duration less than 90 min 5.MPG grade I & II

Exclusion criteria

Exclusion criteria: 1. Patients having any abnormality of the neck, 2.Anticipated difficult airway 3.Upper respiratory tract infections 4.History of obstructive sleep apnoea 5.History of allergy to one or more drugs and latex. • Duration of surgery >2hrs • Cervical spine fracture or instability • Increased risk of aspiration(GERD, hiatus hernia, pregnant pt) • Device placements had failed after three attempts

Design outcomes

Primary

Measure	Time frame
Establish superior supraglottic airway device between LMA proseal and I-gel in anaesthetized patients on spontaneous ventilation during daycare procedureTimepoint: parameters are assessed at pre-induction, post induction, at time of insertion of device, at every 1 min for 5 min, at every 5 min for 30 min and at the time of removal of device	—

Secondary

Measure	Time frame
I-gel and LMA proseal under the following : 1. Ease of airway device insertion- easy/difficult/failed 2. No. of attempts taken to insert the device 3. Hemodynamic response 4. Oxygenation 5. Ventilation 6. Time taken for airway device insertion 7. Peak airway pressure 8. Intraabdominal pressure 9. Risk of aspiration 10. Post-operative complications (Post removal cough, laryngospasm, blood on device) Timepoint: one year	—

Measure

Time frame

I-gel and LMA proseal under the following : 1. Ease of airway device insertion- easy/difficult/failed 2. No. of attempts taken to insert the device 3. Hemodynamic response 4. Oxygenation 5. Ventilation 6. Time taken for airway device insertion 7. Peak airway pressure 8. Intraabdominal pressure 9. Risk of aspiration 10. Post-operative complications (Post removal cough, laryngospasm, blood on device) Timepoint: one year

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Countries

India

Contacts

Public ContactAjay Kumar Chaudhary

King Georges Medical University Lucknow

3006singh.neha@gmail.com9582744669

Outcome results

None listed

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