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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

Evaluation of LMA Supreme Supraglottic Airway (SGA) in Caesarean Section: A Clinical Study on Safety and Efficacy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/03/105139
Enrollment
50
Registered
2026-03-02
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O82- Encounter for cesarean delivery without indication

Interventions

Intervention1: LMA Supreme Supraglottic Airway Device: Insertion Of Lma Supreme After Rapid Sequence Induction For Airway Management In Elective Caesarean Section Under General Anaesthesia. Device Pla

Sponsors

Government medical college Jammu
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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 InterventionTimepoint: From Device Insertion Until Completion Of Surgery

Secondary

MeasureTime frame
Maintenance Of Heart Rate And Blood Pressure Within Twenty Percent Of Baseline ValuesTimepoint: From Induction Of Anaesthesia Until Completion Of Surgery ;Presence Of Blood On Device Or Evidence Of Mucosal InjuryTimepoint: Immediately After Removal Of LMA Supreme;Neonatal outcomes Assessed Using Apgar ScoreTimepoint: At One Minute And Five Minutes After Delivery;Ph Measurement At Distal Tip Of Lma Supreme To Detect Gastric Content ExposureTimepoint: Immediately After Device Removal;Incidence Of Nausea Or VomitingTimepoint: From End Of Surgery Up To Twelve Hours Postoperatively

Countries

India

Contacts

Public ContactSIVASHREE S P

GOVERNMENT MEDICAL COLLEGE JAMMU

sivashree1326@gmail.com06005405676

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026