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Comparing pressure changes in two airway devices used for breathing under anesthesia during breast surgery.

Comparative study of intracuff pressure changes in LMA ProSeal™ and LMA Supreme™ supraglottic airway devices used during breast surgery. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097214
Enrollment
50
Registered
2025-11-11
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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: Airway secured using LMA Supreme™ supraglottic airway device.: Patients airway is secured with appropriate sized LMA Supreme™ supraglottic airway device by inflating the cuff after inse

Sponsors

Vinayaka Missions Kirupananda Variyar Medical College and Hospitals
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient providing written informed consent 2. Age group: 18 to 60 years 3. Patients undergoing elective breast surgery under general anesthesia 4. American Society of Anesthesiologists Physical Status (ASA-PS) I, II 5.Female patients

Exclusion criteria

Exclusion criteria: 1. Patient refusal or inability to provide informed consent 2. Age less than 18 or more than 60 years 3. American Society of Anesthesiologists Physical Status (ASA-PS) III or higher 4. Obese patients 5. Restricted mouth opening of less than 2.5cm 6. Patients at increased risk of aspiration of gastric contents (GERD, esophageal strictures, achalasia cardia, inadequate period of NPO etc.)

Design outcomes

Primary

MeasureTime frame
Primary objective is to compare the changes in cuff pressure that may occur when using LMA ProSeal™ and LMA Supreme™ during breast surgeries under general anesthesia.Timepoint: Cuff pressure is recorded at 20-minute intervals from the insertion till the removal of the device.

Secondary

MeasureTime frame
Secondary objectives are to evaluate the insertion time and observe complications associated with the procedure.Timepoint: Insertion time is recorded from when the anesthesiologist picks up the device till adequate placement of the device is confirmed. Complications associated with the procedure are observed immediately, after 1 hour, 4 hours, 8 hours and 12 hours.

Countries

India

Contacts

Public ContactDr Raut Akshada Sonba

Vinayaka Missions Kirupananda Variyar Medical College and Hospitals

naveenasen@gmail.com9486198407

Outcome results

None listed

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