| CTRI Number |
CTRI/2025/08/092377 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Which head position makes Supraglottic Airway Device placement easier during surgery in patients undergoing elective surgery under general anaesthesia |
|
Scientific Title of Study
|
Comparison of two different head positions for successful insertion of supraglottic airway device in adult patients undergoing elective surgery under general anaesthesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Harsh Jain |
| Designation |
Post Graduate Student |
| Affiliation |
ABVIMS and Dr. Ram Manohar Lohia Hospital,New Delhi |
| Address |
Room no. 301 3rd floor Department of Anaesthesia,ABVIMS and DR. RML HOSPITAL
Central
DELHI
110001
India |
| Phone |
9540480417 |
| Fax |
|
| Email |
DRHARSHJAIN07@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nidhi Yadav |
| Designation |
Professor |
| Affiliation |
ABVIMS and Dr. Ram Manohar Hospital,New Delhi |
| Address |
Room no. 301 3rd floor Department of Anaesthesia,ABVIMS and DR. RML HOSPITAL
Central
DELHI
110001
India |
| Phone |
9711936946 |
| Fax |
|
| Email |
yadavnids@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyoti Singh |
| Designation |
Professor |
| Affiliation |
ABVIMS and Dr. Ram Manohar Hospital,New Delhi |
| Address |
Room no. 301 3rd floor Department of Anaesthesia,ABVIMS and DR. RML HOSPITAL
Central
DELHI
110001
India |
| Phone |
9910241887 |
| Fax |
|
| Email |
drjyoti.md@gmail.com |
|
|
Source of Monetary or Material Support
|
| ABVIMS and Dr. Ram Manohar Lohia Hospital, Baba Kharak Singh Marg, Near Gurudwara Bangla Sahib, Cannaught Place, New Delhi-110001 |
|
|
Primary Sponsor
|
| Name |
Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital |
| Address |
Department of Anaesthesia ABVIMS and Dr. RML Hospital New Delhi 110001 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Harsh Jain |
ABVIMS and Dr. Ram Manohar Lohia Hospital , New Delhi |
Room no. 301 Department of Anaesthesia ABVIMS and Dr. RML Hospital, New Delhi 110001
Central
DELHI |
9540480417
drharshjain07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ABVIMS and Dr. Ram Manohar Lohia Hospital, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brimacombe Scoring |
We will insert the fibre optic bronchoscope through the port of suraglottic airway device and assess the Brimacombe Scoring |
| Comparator Agent |
Head position (5 cm head elevation) |
In this group of people, we will insert the supraglottic airway device at 5 cm head elevation and further parameters will be assessed |
| Comparator Agent |
Head position( 0 cm head elevation) |
In this group of people, we will insert the supraglottic airway device at 0 cm head elevation and further parameters will be assessed |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Elective surgical procedure under General Anaesthesia |
|
| ExclusionCriteria |
| Details |
Trauma,Tumor or deformity of Upper Airway
Patient with Thyroid and Neck Swelling
Fracture and deformity of Cervical Spine
Past History of Difficult Intubation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| First attempt success rate (using BRIMACOMBE SCORING) |
From Baseline till 5 minutes after insertion of Supraglottic Airway Device |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Total time taken for SAD insertion
Complications(if any) |
Total time taken for SAD insertion & patients vitals after 5 minutes of the supraglottic airway device insertion |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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 |