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Clinical Trials/CTRI/2025/07/090806
CTRI/2025/07/090806CompletedPhase 4

Ultrasonographic assessment of ProSealTM laryngeal mask airway position pre-and post-laparoscopy surgery: A pilot study

University college of medical sciences1 site in 1 country30 target enrollmentStarted: August 1, 2025Last updated:

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
30
Locations
1
Primary Endpoint
1. Incidence of malpositioning of PLMA at the end of laparoscopic surgery using US

Study Overview

Brief Summary

We have planned to do this  pilot study to find out incidnce of Proseal LMA malposition at end of Laparoscopic surgeries using Ultrasound Scanning. We also propose that placing proseal LMA in optimal position and confirming objectively with ultrasound decreases incidence of its malposition at end of laparoscopic surgeries and thus reducing incidence of complications like aspiration and regurgitation etc.

we could successfully complete this pilot study with 30 participants in this study. we did not come across any major or minor complication of using proseal LMA in laparoscopy surgeries and USG proved to be useful tool in ensuring optimum postition before surgery and also helped in checking position after surgery.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • ASA I, II patients between age group 18-65 years who will undergo elective laparoscopic surgery requiring general anaesthesia.

Exclusion Criteria

  • containdication to use Proseal LMA, BMI more than 30, denial of consent, severe respiratory disease, pregnancy.

Outcomes

Primary Outcomes

1. Incidence of malpositioning of PLMA at the end of laparoscopic surgery using US

Time Frame: Immidiately after completion of surgery and before removal of PLMA device.

Secondary Outcomes

  • 1. Position of PLMA after placement using US.(2. Reconfirmation of position of PLMA using US at the end of laparoscopic surgery.)

Investigators

Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Poonam Rani

University college of medical sciences

Study Sites (1)

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