| CTRI Number |
CTRI/2025/04/084243 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
06/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study of assessing the glottic view with 2 different supraglottic airway devices among patients undergoing elective surgical procedure under general anesthesia |
|
Scientific Title of Study
|
Comparative study of assessing the glottic view with proseal and I GEL supraglottic airway devices- randomized control study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shri Sravan |
| Designation |
POST GRADUATE |
| Affiliation |
PSG institute of medical sciences and research |
| Address |
Room no 1, 2nd floor, Department of anaesthesia PSGIMSR,
Off, Avinashi road, Peelamedu, Coimbatore, Tamil Nadu- 641004
Coimbatore
TAMIL NADU
641004
India |
| Phone |
9600067259 |
| Fax |
|
| Email |
sravan199625@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ganesan.C |
| Designation |
Head of department |
| Affiliation |
PSG institute of medical sciences and research |
| Address |
Room No-1, 2nd floor,Department of anaesthesia, PSGIMSR,
Off, Avinashi road, Peelamedu, Coimbatore, Tamil Nadu- 641004
Coimbatore
TAMIL NADU
641004
India |
| Phone |
9443368457 |
| Fax |
|
| Email |
ganesan1168@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shri Sravan |
| Designation |
POST GRADUATE |
| Affiliation |
PSG institute of medical sciences and research |
| Address |
Room No- 1, 2nd floor,Department of anaesthesia, PSGIMSR,
Off, Avinashi road, Peelamedu, Coimbatore, Tamil Nadu- 641004
Coimbatore
TAMIL NADU
641004
India |
| Phone |
9600067259 |
| Fax |
|
| Email |
sravan199625@gmail.com |
|
|
Source of Monetary or Material Support
|
| PSG Institute of medical sciences and research,
Off, Avinashi road, Peelamedu,
Coimbatore,
Tamil Nadu- 641004 |
|
|
Primary Sponsor
|
| Name |
Dr Shri Sravan |
| Address |
Room no-350, PSG mens hostel,
PSG Institute of medical sciences and research, Off, Avinashi road, Peelamedu, Coimbatore, Tamil Nadu- 641004 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Shri Sravan |
PSG Institute of medical sciences and research |
PSG IMSR, Department of anaesthesiology,
Off, Avinashi road, Peelamedu, Coimbatore
Tamil Nadu- 641004
Coimbatore
TAMIL NADU |
9600067259
sravan199625@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional human ethics committee PSG IMSR |
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 |
| Comparator Agent |
I GEL, supraglottic airway device |
glottic opening assessed using fiberoptic bronchoscope immediately after insertion of I-GEL supraglottic airway device among patients undergoing elective surgical procedures under general anaesthesia.
Frequency-1
duration- 5 mins |
| Intervention |
Proseal, supraglottic airway device |
glottic opening assessed using fiberoptic bronchoscope immediately after insertion of Proseal supraglottic airway device among patients undergoing elective surgical procedures under general anaesthesia.
Frequency-1
duration-5 mins |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. American society of anaesthesiology physical status classification, class 1,2 and 3 patients.
2. Elective surgical procedures planned under general anaesthesia using proseal and I GEL supraglottic airway devices. |
|
| ExclusionCriteria |
| Details |
1. Pregnancy.
2. Any contraindication to the use of supraglottic airway devices (uncontrolled gastro-esophageal reflux, oropharyngeal pathology or gross deformities, edentulous, loose tooth).
3. Difficult airway.
4. Patient refusal. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessing the glottic view obtained between Proseal and I GEL supraglottic airway devices |
Baseline glottic opening will be assessed immediately after airway placement among patients undergoing elective surgical procedures under general anaesthesia, using supraglottic airway devices |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessing the adequacy of ventilation after supraglottic airway device placement. |
adequacy of ventilation will be assessed once immediately after airway placement during planned elective surgical procedures under general anaesthesia, using supraglottic airway devices. |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
20/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/04/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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
|
BACKGROUND- Supraglottic airway devices are an essential part of managing difficult airway situation, wherein they are used to maintain ventilation. A fiberoptic bronchoscope can be inserted via a supraglottic airway and the glottic aperture visualized for adequate opening so that endotracheal intubation can be facilitated with the help of a tracheal tube exchanger. Brimacombe grading system will help to grade the glottic opening. This study aimed to compare the best glottic view obtained between Proseal and I GEL supraglottic airway device, assessed with fiberoptic bronchoscope using brimacombe grading.-
METHODOLOGY- This prospective randomized controlled study, includes patients undergoing elective surgical procedures under general anesthesia using supraglottic airway device. Two groups: GROUP P- patients undergoing elective surgical procedures using Proseal supraglottic airway and GROUP I- patients undergoing elective surgical procedure under IGEL supraglottic airway. The primary objective is to assess the best glottic opening obtained between the two devices. The secondary objectives are to assess the adequacy of ventilation after supraglottic airway device placement and the number of attempts required for insertion of device
CONCLUSION- This study provides valuable insights into the glottic view obtained with Proseal and I GEL supraglottic airway using fiberoptic bronchoscope and brimacombe grading. It helps in repurposing the more commonly used supraglottic airway device as alternatives to the intubating LMA. By assessing the glottic view, adequacy of ventilation, and ease of insertion this study enhances the understanding of each device’s effectiveness in managing a difficult airway situation. The results may help guide clinical decision making, improving airway management strategies and patient outcomes. |