| CTRI Number |
CTRI/2025/07/090806 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To check if correct position of laryngeal mask airway is maintained at end of laparoscopy
surgery with help of Ultrasound : A pilot study |
|
Scientific Title of Study
|
Ultrasonographic assessment of ProSealTM laryngeal mask airway position pre-and post-laparoscopy
surgery: A pilot study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Poonam Rani |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
University college of medical sciences |
| Address |
2nd floor anaesthesia office
Guru Teg Bahadur Hospital Delhi
North East
DELHI
110095
India |
| Phone |
9878688401 |
| Fax |
|
| Email |
poonam.ronsa.22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Poonam Rani |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
University college of medical sciences |
| Address |
2nd floor anaesthesia office GTB Hospital Delhi
East
DELHI
110095
India |
| Phone |
9878688401 |
| Fax |
|
| Email |
poonam.ronsa.22@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Poonam Rani |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
University college of medical sciences |
| Address |
2nd floor anaesthesia office
Guru Teg Bahadur Hospital Delhi
East
DELHI
110095
India |
| Phone |
9878688401 |
| Fax |
|
| Email |
poonam.ronsa.22@gmail.com |
|
|
Source of Monetary or Material Support
|
| University College of Medical Sciences, New Delhi Pin-110095 |
|
|
Primary Sponsor
|
| Name |
University college of medical sciences |
| Address |
University college of medical sciences, New Delhi India Pin -110095 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Poonam Rani |
Guru Teg Bahadur Hospital |
operation theatres at 4th and 7th floor.
North East
DELHI |
9878688401
poonam.ronsa.22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee- human rsearch |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Anterior neck USG |
correction of Position of PLMA if it is found suboptimal with USG guidance |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA I, II patients between age group 18-65 years who will undergo elective laparoscopic surgery requiring general anaesthesia |
|
| ExclusionCriteria |
| Details |
containdication to use Proseal LMA, BMI more than 30, denial of consent, severe respiratory disease, pregnancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Incidence of malpositioning of PLMA at the end of laparoscopic surgery using US |
Immidiately after completion of surgery and before removal of PLMA device. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Position of PLMA after placement using US.
2. Reconfirmation of position of PLMA using US at the end of laparoscopic surgery.
3. Determine the rate of optimization for suboptimal PLMA placements detected by US before starting surgery.
4. Compare the incidence of PLMA malposition seen with US, & clinical evaluation by leak test.
5. Determine the rate of postoperative complications like sore throat, hoarseness & tongue edema etc. & risk factors.
|
Immidiately after induction of anaesthesia, immidiately after completion of surgery.
for complications, immidiately when patient gains consciouness & 1 hour after surgery in post operative room. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| Date of Study Completion (India) |
31/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
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. |