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Effect of change in pressure on air leak and blood oxygen levels comparing two airway devices, i-gel and LMA protector.

Comparison of effect of variable peep on leakage and oxygenation using i-gel and LMA® Protector - A parallel-group randomized controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/03/050720
Enrollment
90
Registered
2023-03-15
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

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: Incremental PEEP while using LMA protector: It is a single-use device and will be used only once in a patient. It will be used for the entire duration of surgery. After Anaesthesia indu

Sponsors

Ruchi Verma, Department of Anaesthesiology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA physical status I or II, Patients posted for surgical intervention under general anaesthesia with SAD

Exclusion criteria

Exclusion criteria: Patient refusal Patients at increased risk of aspiration including GERD, Patients with BMI >30kg/m2 H/O Bronchial asthma or chronic bronchitis Pregnant patients Edentulous patients Patients with ASA grade III and IV Surgery in prone or lateral position Laparoscopic surgery

Design outcomes

Primary

MeasureTime frame
Leak volume Leak fraction Significant leak present/absent Timepoint: After 20 minutes of each level of set PEEP (0,5,8,10)

Secondary

MeasureTime frame
Oxygenation parameters- SpO2, PaO2 Ventilatory parameters- EtCO2, PaCO2 Compliance, Peak airway pressure, Mean airway pressure Complications â?? Sore throat, aspiration, need for intubation, disconnection.Timepoint: SpO2, PaO2, EtCO2, PaCO2 Compliance, Peak airway pressure, Mean airway pressure After 20 minutes of each level of set PEEP (0,5,8,10) Sore throat- 24 hrs after surgery, aspiration, need for intubation, and disconnection anytime during surgery

Countries

India

Contacts

Public ContactRuchi Verma

Sanjay Gandhi Post Graduate Institute of Medical Sciences

ruchiv197@gmail.com8004221393

Outcome results

None listed

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