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Clinical Trials/CTRI/2025/08/092377
CTRI/2025/08/092377
Not yet recruiting
Not Applicable

Comparison of two different head positions for successful insertion of supraglottic airway device in adult patients undergoing elective surgery under general anaesthesia

Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital1 site in 1 country90 target enrollmentStarted: August 20, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital
Enrollment
90
Locations
1
Primary Endpoint
First attempt success rate (using BRIMACOMBE SCORING)

Overview

Brief Summary

This prospective, randomized study aims to compare the success of supraglottic airway device (SAD) insertion in two different head positions [without elevation (Group X) and with 5 cm head elevation (Group Y)] in adult patients undergoing elective surgery under general anaesthesia. Following Institutional Ethics Committee approval and written informed consent, 90 patients will be enrolled. Preoperative assessment will include airway evaluation using Mallampati score and mouth opening. Standard ASA monitoring will be applied, and patients will be premedicated with midazolam and fentanyl, followed by induction with propofol and muscle relaxation using vecuronium.

Patients will be randomized into two groups based on head positioning. A properly sized SAD will be inserted using the introducer technique with the neck in extension, and cuff inflation will be standardized at 60 cm H2O. The success of insertion will be confirmed using fibreoptic bronchoscopy and Brimacombe scoring. Time to successful insertion will be recorded until the first square EtCO2 waveform. Failure on first attempt will result in exclusion from the study, and airway management will proceed with endotracheal intubatio

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

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

Inclusion Criteria

  • Elective surgical procedure under General Anaesthesia.

Exclusion Criteria

  • Trauma,Tumor or deformity of Upper Airway Patient with Thyroid and Neck Swelling Fracture and deformity of Cervical Spine Past History of Difficult Intubation.

Outcomes

Primary Outcomes

First attempt success rate (using BRIMACOMBE SCORING)

Time Frame: From Baseline till 5 minutes after insertion of Supraglottic Airway Device

Secondary Outcomes

  • Total time taken for SAD insertion(Complications(if any))

Investigators

Sponsor
Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Harsh Jain

ABVIMS and Dr. Ram Manohar Lohia Hospital,New Delhi

Study Sites (1)

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