To study and compare maximum pressure sustained without causing leak by two airway management devices (second-generation supraglottic device with and without cuff) during controlled breathing in children.

Comparison of maximum positive end-expiratory pressure (PEEP) sustained without leak with cuffed and uncuffed second-generation supraglottic airway devices in paediatric patients: A prospective randomized controlled trial - NIL

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/02/080019

Enrollment

Registered

2025-02-07

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

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: Group C (Cuffed device): After induction of anaesthesia, the airway will be secured using proper size Cuffed second-generation supraglottic airway device (ProSeal). The PEEP will be suc

Eligibility

Inclusion criteria

Inclusion criteria: 1. Paediatric patients aged between 6 to 14 years 2. Belonging to either gender 3. Belonging to American Society of Anesthesiologists (ASA) physical status 1-2, 4. Scheduled for elective surgeries lasting for 60 to 120 minutes.

Exclusion criteria

Exclusion criteria: •Patients with difficult airway •Patient with congenital anomalies that includes oropharynx and nasopharynx, •Patients with respiratory and cardiac dysfunction •Preoperative poor lung compliance.

Design outcomes

Primary

Measure	Time frame
To assess and compare the maximum PEEP that can be effectively delivered without leak with ProSealTM and i-gel®.Timepoint: After airway device insertion till 60 minutes.	—

Secondary

Measure	Time frame
1. To compare the incidence of gastric air insufflation using gastric ultrasound 2. To compare first attempt and overall success rate of correct placement 3. To compare postoperative airway morbidities [postoperative sore throat (POST), Dysphagia, Cough etc) 4. To compare postoperative complications Timepoint: From device insertion till first 6 hours of postoperative period.	—

Countries

India

Contacts

Public ContactKaviprasad K

Department of Anaesthesiology and Critical Care, AIIMS Jodhpur.

drmsadik@gmail.com9414849733

Outcome results

None listed

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