Comparison of malposition of i-gel in paediatric patients after blind and C-MAC guided insertion- A Randomised controlled trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 94
- Locations
- 1
- Primary Endpoint
- To compare the incidence of malposition between two insertion techniques (Blind vs C-MAC guided) of i-gel where the correct position will be confirm by using flexible laryngoscope
Study Overview
Brief Summary
. The use of supraglottic airway (SGA) has also been increased in routine airway management during general anaesthesia practice.Paediatric SGA devices have also become popular and are being used in over 50% of general anaesthetic procedures as reflected by a survey of the Association of Paediatric Anaesthetists of Great Britain and Ireland.Blind insertion often result in malposition of supraglottic airway with incidence ranging from 50-80%, as confirmed by various imaging studies including magnetic resonance image(MRI), computer tomography scan (CT) and X-ray soft tissue neck.The use of VL for SGA placement in paediatric patients have not been studied yet. Hence, this study is planned to compare the conventional versus C-MAC guided insertion of i-gel in paediatric patient. We hypothesize that C-MAC guided insertion will result in better positioning of i-gel compared to blind insertion in paediatric patients undergoing surgery in supine position
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Eligibility Criteria
- Ages
- 2.00 Year(s) to 5.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •American society of Anaesthesiologist (ASA) physical status I and II, aged between 2 to 5 years, scheduled for elective surgery in supine position under general anaesthesia will be enrolled.
Exclusion Criteria
- •Patients with anticipated difficult airway, having upper respiratory tract infection, patients at risk of gastroesophageal regurgitation, history of upper gastrointestinal surgery, children having limited mouth opening, mass in pharyngeal/laryngeal cavity and syndromic babies will be excluded from the study.
Outcomes
Primary Outcomes
To compare the incidence of malposition between two insertion techniques (Blind vs C-MAC guided) of i-gel where the correct position will be confirm by using flexible laryngoscope
Time Frame: To compare the incidence of malposition between two insertion techniques (Blind vs C-MAC guided) of i-gel where the correct position will be confirm by using flexible laryngoscope five minute after induction of anesthesia
Secondary Outcomes
- To compare the insertion characteristics (number of attempts, ease of insertion and time required for successful insertion) of i-gel.(To compare Oropharyngeal seal pressure (OPLP) between the two techniques.)