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Comparing two airway devices for ease of use in minor surgical procedures

A COMPARATIVE STUDY OF CLINICAL PERFORMANCE OF TWO SUPRAGLOTTIC AIRWAY DEVICES I-GEL VS COBRA PLA FOR MINOR SURGICAL PROCEDURES.

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/01/048855
Enrollment
50
Registered
2023-01-10
Start date
Unknown
Completion date
Unknown
Last updated
2023-02-06

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: comparison of ease of insertion , outcome of adverse events , bleeding and post-operative sore throat.: will observe patients for upto 24 hours after they have undergone procedure. Inte

Sponsors

Sree Balaji medical college and hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients undergoing minor surgical procedures at Sree Balaji Medical College Hospital 1.ASA grade â?? I, II , III 2.Age between 15 & 55yrs Exlcusion criteria ; 1.patients not giving consent for study 2.patients with inadequate NPO. 3.patients with severe systemic illness. 4.patients with restricted mouth opening. 5.patients with underlying lung pathology.

Exclusion criteria

Exclusion criteria: • 1.Patient refusal. • 2.ASA grade â?? IV • 3.Patients with complications like severe anemia, hypovolemia, • septicemia, shock. • 4. Bleeding disorders or on anticoagulant therapy • 5.Local infection in pharynx. • 6.Patients with Full Stomach • 7.Patients with upper airway obstruction

Design outcomes

Primary

MeasureTime frame
primary outcome is to identify which device is superior to the other in terms of the ease of insertion, hemodynamic changes which occur during device insertion studied within 10 mins upon its insertion.Timepoint: immediately following the device insertion , 10 mins after device insertion and 30 mins after device insertion.

Secondary

MeasureTime frame
secondary outcome is to assess post-operative complications which can occur as a result of device insertion such as post-operative sore throat , hoarseness of voiceTimepoint: the time period will be 24 hours following surgery in the post-op period.

Countries

India

Contacts

Public ContactDrShashank krishnakumar

Dr.Bhaygyavardhan Botta , Professor

Bhagyavardhan@gmail.com9962404296

Outcome results

None listed

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