Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/CTRI/2024/11/076290
CTRI/2024/11/076290Not yet recruitingPhase 4

A Comparative Study Of Igel Insertion Blind Vs Direct Vision Placement In Adult Patients

Government Medical College Vadodara1 site in 1 country60 target enrollmentStarted: November 25, 2024Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit

Trial Snapshot

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Oropharyngeal Leak Pressure
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

•Malpositioning of SAD can lead to various complications such as increased chances of aspiration, insufficient tidal volume, air leak.

•

• Newer trend is towards securing airway devices under vision rather than inserting them blindly to reduce such complications..

•

•This study is designed to compare Ideal Positioning of Igel by Blind insertion with that of Larnygoscopy-guided insertion using Oropharyngeal Leak Pressure as Primary Indicator.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)

Inclusion Criteria

  • •Willingness and consent for the Procedure.
  • •Patients posted for Elective Sugeries whose Duration is between 1- 2 hour and Short Procedure requiring General Anesthesia.
  • •Adult aged between 18-60 years and Weight between 30-70 kg and requiring IGEL no.
  • •Patients graded with American Society of Anaesthesiologists (ASA) physical status I-II-III in preoperative assessment.
  • •Gender: Male and Female.

Exclusion Criteria

  • •Unwillingness to Participate in Study.
  • •Patient with uncontrolled Medical Condition like Hypertension, Diabetes Mellitus, Recent history of Ischaemic Heart Disease.
  • •Pregnant Women.
  • •Morbidly Obese Patient.
  • •Patient with Difficult Airway (Small Mouth Opening, Orofacial Deformities).
  • •Patient with Full Stomach.

Outcomes

Primary Outcomes

Oropharyngeal Leak Pressure

Time Frame: After insertion of Igel

Secondary Outcomes

  • Ideal Positioning of IGel by Brimacombe Fibreoptic Brochoscope Scoring(Hemodynamic Parameters like Heart Rate, Systolic and Diastolic Pressure, Mean Arterial Pressure, Sp02, Etco2.)

Investigators

Sponsor
Government Medical College Vadodara
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Moxesh Shah

Government Medical College Vadodara

Study Sites (1)

Loading locations...

Similar Trials

Not yet recruiting
Not Applicable
Airway spatula helps for insertion of I-gel Supraglottic airway device during anesthesia
CTRI/2024/08/072808Dr Swathi S80
Not yet recruiting
Phase 1
Comparison of two techniques of inserting a airway device in pediatric age group
CTRI/2025/02/081026K S Hegde Medical Academy96
Not yet recruiting
Not Applicable
A study comparing three ways of placing a soft breathing device during anesthesia.
CTRI/2025/11/097668Swami Dayanand Hospital264
Not yet recruiting
Phase 3
comparative evaluation of clinical efficiency of two different block technique in pediatric dental patients
CTRI/2025/04/083992Harsh Sanjaykumar Baldawa62
Not yet recruiting
Not Applicable
Which head position makes Supraglottic Airway Device placement easier during surgery in patients undergoing elective surgery under general anaesthesia
CTRI/2025/08/092377Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital90