| CTRI Number |
CTRI/2025/05/086269 [Registered on: 05/05/2025] Trial Registered Prospectively |
| Last Modified On: |
01/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Appropriate size selection strategies for I gel |
|
Scientific Title of Study
|
A randomized comparison of size selection strategies for I Gel with regard to patient weight and thyroid cartilage width measurement |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anjum Naz |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room No 1060, Department of Anaesthesiology, AIIMS Kalyani,
Basantpur, Saguna.
Nadia
WEST BENGAL
741245
India |
| Phone |
07980645318 |
| Fax |
|
| Email |
dranjumnaz75@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anjum Naz |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
AIIMS Kalyani,
Basantpur, Saguna.
AIIMS Kalyani,
Basantpur, Saguna,
Nadia
WEST BENGAL
741245
India |
| Phone |
07980645318 |
| Fax |
|
| Email |
dranjumnaz75@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anjum Naz |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
AIIMS Kalyani,
Basantpur, Saguna.
AIIMS Kalyani,
Basantpur, Saguna,
WEST BENGAL
741245
India |
| Phone |
07980645318 |
| Fax |
|
| Email |
dranjumnaz75@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Kalyani, Basantpur, Saguna, Nadia, West Bengal, 741245
India |
|
|
Primary Sponsor
|
| Name |
AIIMS Kalyani |
| Address |
AIIMS Kalyani, Basantapur, Saguna, Nadia, West Bengal.
PIN-741245
India |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| NIL |
Not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anjum Naz |
AIIMS Kalyani |
Main OT Complex, First Floor, IPD, AIIMS Kalyani,
Basantpur, Saguna,
Nadia
WEST BENGAL |
7980645318
dranjumnaz75@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee All India Institute of Medical Sciences, Kalyani |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 2||Placement, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
I gel as per Thyroid width |
The maximal width of the thyroid cartilage will be measured from the left and right cornu with Vernier calipers by one investigator, and matched with the widest diameter of the Igel. |
| Comparator Agent |
I gel as per USG. |
The maximum internal width of the thyroid cartilage will be measured with a 5-10 MHz USG probe of (Sonosite S2, FUJIFILM SonoSite Inc.,USA) by one investigator, and matched with the widest diameter of the Igel. |
| Intervention |
I Gel as per weight |
I Gel will be inserted and OLP will be measured |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients requiring General Anesthesia for Surgery
|
|
| ExclusionCriteria |
| Details |
Patient refusal
Weight more than 100kg,
ASA status of 3 or more,
Patients with lung disease, bronchopulmonary dysplasia, cervical disease or head and neck malformations,
History of gastro esophageal reflux,
Emergency surgery
Unstable hemodynamic status |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Measurement of oropharyngeal leak pressure |
After I gel insertion- 0 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. leak fraction (%) calculated as [(TVinsp - TVexp) ÷ TVinsp]
|
After Insertion of I gel- 1 minute |
| Presence of blood on the surface of the device. |
After removal of I gel- 2-3 hours |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
30/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/06/2025 |
| 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 Yet Recruiting |
| 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 study evaluates three methods for selecting the appropriate size of the I-Gel airway device in anesthetized patients: manufacturer’s weight-based formula, external thyroid cartilage width measurement using vernier calipers, and ultrasound-guided internal thyroid cartilage width measurement. A total of 150 patients will be randomized into three groups (n=50 each). Anesthetists and outcome assessors will know group assignments, while participants and data analysts will remain blinded. All patients will receive standard anesthesia management, including IV midazolam, fentanyl, propofol, and atracurium. I-Gel placement will follow the assigned method. Oropharyngeal leakage pressure (OLP) will be measured to assess seal quality, and mechanical ventilation will be initiated in volume-controlled mode. Ultrasound will be used to evaluate I-Gel positioning, focusing on air leakage, epiglottis movement, and asymmetry at the thyroid cartilage and hyoid bone levels. Misplacement will be determined using ultrasound and clinical criteria such as abdominal distension, audible air leaks, or tidal volume loss exceeding 20%. Misplaced devices will be resized, and failed placements will result in tracheal intubation. Postoperative care includes antiemetics, reversal of neuromuscular blockade, and monitoring in the recovery unit. Key outcomes measured include OLP, leak fraction, necessity for manipulation or failure, and presence of blood on the device. Data will be analyzed using SPSS software. Continuous variables will be compared using ANOVA, while categorical variables will be analyzed with the chi-square test. Statistical significance is set at p < 0.05. This study aims to determine whether thyroid cartilage-based sizing methods improve I-Gel placement success and reduce complications compared to the traditional weight-based formula, potentially improving airway management precision.
|