Skip to content

trial of breathing tube through two airway devices

Comparison of intubation success of LMA Fastrach® ETT through I-Gel® or LMA-Fastrach ®: A non-inferiority trial

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/06/007011
Enrollment
120
Registered
2016-06-08
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- patients of either sex, in the age group 18 â?? 60 years belonging to ASA physical status I-II, weighing 50 â?? 90 kg and scheduled for elective surgical procedures requiring tracheal intubation

Interventions

Intervention1: I-gel airway: Flexible silicone tube (FST) used to intubate through I-gel airway Route of administration: Through oral cavity placed over the larynx Duration: I gel airway was removed a

Sponsors

Post Graduate Institute of Medical Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA physical status I-II,weighing 50 â?? 90 kg and scheduled for elective surgical procedures requiring tracheal intubation were included in the study.

Exclusion criteria

Exclusion criteria: ASA III-V patients, contraindication to use of muscle relaxants, anticipated or known difficult intubation or ventilation and patients at increased risk of aspiration or having a history of symptomatic gastroesophageal reflux or hiatal hernia.

Design outcomes

Primary

MeasureTime frame
First pass success rateTimepoint: Appearance of ETCO2 curve on the monitor after intubation through the device in first attempt

Secondary

MeasureTime frame
overall success rate, ease of SGA insertion and intubation, time to SGA insertion and intubation and adverse events.Timepoint: Appearance of ETCO2 graph on the monitor after 3rd attempt when first attempt is unsuccessful. Time taken to insert the SGA from holding the device in hand to appearance of ETCO2 curve on the monitor Time taken to intubate through the LMA from holding the tube to appearance of ETCO2 graph on the monitor Adverse events like sore throat, hoarseness assessed after after extubation(0 hours) and 24 hours after the extubation

Countries

India

Contacts

Public ContactDr Neerja Bhardwaj

PGIMER

neerja.bhardwaj@gmail.com01722756500

Outcome results

None listed

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