| CTRI Number |
CTRI/2026/03/105139 [Registered on: 02/03/2026] Trial Registered Prospectively |
| Last Modified On: |
01/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to Assess the Safety and Effectiveness of the LMA Supreme Breathing Device in Pregnant Women Undergoing Caesarean Section at a Tertiary Care Hospital |
|
Scientific Title of Study
|
Evaluation of LMA Supreme Supraglottic Airway (SGA) in Caesarean Section: A Clinical Study on Safety and Efficacy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR RENU WAKHLOO |
| Designation |
PROFESSOR |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE JAMMU |
| Address |
GOVERNMENT MEDICAL COLLEGE JAMMU
BAKSHI NAGAR JAMMU
DR SIVASHREE S P D/O S PALANIVELU OPPOSITE TO KARAN HOTEL AND SUDESH SHARMA CLINIC 24S BAKSHI NAGAR JAMMU
Jammu
JAMMU & KASHMIR
180001
India |
| Phone |
9419193040 |
| Fax |
|
| Email |
drrenuwakhloo2710@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SIVASHREE S P |
| Designation |
POST GRADUATE |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE JAMMU |
| Address |
DR SIVASHREE S P D/O S PALANIVELU 421 F1 SAROJINEES FLAT EAST END ROAD PANEER NAGAR MOGDR SIVASHREE S P D/O S PALANIVELU 421 F1 SAROJINEES FLAT EAST END ROAD PANEER NAGAR MOG
Chennai
TAMIL NADU
600037
India |
| Phone |
06005405676 |
| Fax |
|
| Email |
sivashree1326@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SIVASHREE S P |
| Designation |
POST GRADUATE |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE JAMMU |
| Address |
DR SIVASHREE S P D/O S PALANIVELU 421 F1 SAROJINEES FLAT EAST END ROAD PANEER NAGAR MOGDR SIVASHREE S P D/O S PALANIVELU 421 F1 SAROJINEES FLAT EAST END ROAD PANEER NAGAR MOG
Chennai
TAMIL NADU
600037
India |
| Phone |
06005405676 |
| Fax |
|
| Email |
sivashree1326@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Government medical college Jammu |
| Address |
Government Medical College Jammu
Maheshpura Chowk
Bakshi Nagar
Jammu
Jammu And Kashmir
Pin Code 180001
India |
| 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 Renu Wakhloo |
Government Medical College And Associated Hospitals Jammu |
Department Of Anaesthesiology
Government Medical College And Associated Hospitals
Bakshi Nagar
Jammu Jammu And Kashmir
India Pin Code 180001
Jammu
JAMMU & KASHMIR |
9419193040
drrenuwakhloo2710@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government Medical College, Jammu (IEC-GMCJ) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
LMA Supreme Supraglottic Airway Device |
Insertion Of Lma Supreme After Rapid Sequence Induction For Airway Management In Elective Caesarean Section Under General Anaesthesia. Device Placement Confirmed By Capnography Chest Rise And Oxygen Saturation. Orogastric Tube Inserted Through Gastric Channel And Anaesthesia Maintained With Standard Protocol. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant Women Scheduled For Elective Caesarean Section Under General Anaesthesia. Asa Physical Status Two. Gestational Age Thirty Seven Weeks Or More. Body Mass Index Between Eighteen Point Five And Thirty Five Kilogram Per Meter Square. Mallampati Grade One Or Two. Fasting For At Least Eight Hours For Solids. Low Risk Of Aspiration Confirmed By Gastric Ultrasound. Written Informed Consent Obtained. |
|
| ExclusionCriteria |
| Details |
Refusal To Participate. Emergency Caesarean Section. Asa Physical Status Three Or More. Mallampati Grade Three Or Four. Known Difficult Airway. History Of Gastroesophageal Reflux Disease. High Risk Of Aspiration Or Delayed Gastric Emptying. Any Contraindication To Supraglottic Airway Device. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Adequacy Of Ventilation will be Achieved Using Lma Supreme Defined By Oxygen Saturation Ninety Five Percent Or More With Visible Chest Expansion And Continuous Capnography Without Need For Additional Airway Intervention |
From Device Insertion Until Completion Of Surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Maintenance Of Heart Rate And Blood Pressure Within Twenty Percent Of Baseline Values |
From Induction Of Anaesthesia Until Completion Of Surgery
|
| Presence Of Blood On Device Or Evidence Of Mucosal Injury |
Immediately After Removal Of LMA Supreme |
| Neonatal outcomes Assessed Using Apgar Score |
At One Minute And Five Minutes After Delivery |
| Ph Measurement At Distal Tip Of Lma Supreme To Detect Gastric Content Exposure |
Immediately After Device Removal |
| Incidence Of Nausea Or Vomiting |
From End Of Surgery Up To Twelve Hours Postoperatively
|
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/03/2026 |
| Date of Study Completion (India) |
02/07/2026 |
| Date of First Enrollment (Global) |
15/03/2026 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
This Prospective Clinical Study Is Designed To Evaluate The Safety And Efficacy Of Lma Supreme Supraglottic Airway Device In Elective Caesarean Section Under General Anaesthesia. Pregnancy Is Associated With Physiological Changes That Increase The Risk Of Difficult Airway Management And Aspiration. Second Generation Supraglottic Airway Devices Provide A Gastric Drain Channel And Improved Airway Seal Which May Offer A Safe Alternative To Endotracheal Intubation In Selected Low Risk Parturients. The Study Will Assess Successful Ventilation Hemodynamic Stability Airway Related Complications And Neonatal Outcome In Fifty Patients Undergoing Elective Caesarean Delivery.
|