| CTRI Number |
CTRI/2024/04/066239 [Registered on: 24/04/2024] Trial Registered Prospectively |
| Last Modified On: |
03/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Easier and safer alternate method of inserting Igel in patients undergoing surgery under General anesthesia- A Prospective study |
|
Scientific Title of Study
|
Conventional and Reverse insertion of Igel in patients undergoing surgery under General anesthesia - A Prospective 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 |
Dr Thupili Poshitha Sai |
| Designation |
Post graduate |
| Affiliation |
Dr B R Ambedkar medical college and hospital |
| Address |
Dr BRAMCH OT complex
Department of Anesthesia
DR B R Ambedkar Medical College and Hospital
Shampura Main road
K G Halli
Bangalore
Bangalore
KARNATAKA
560045
India |
| Phone |
9949941347 |
| Fax |
|
| Email |
poshithasai1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Reshma B M |
| Designation |
Associate Professor |
| Affiliation |
Dr B R Ambedkar medical college and hospital |
| Address |
OT Complex
Department of Anesthesiology
Dr B R Ambedkar Medical College and Hospital
Shampura main road
K G Halli
Bangalore
Bangalore
KARNATAKA
560045
India |
| Phone |
8892019120 |
| Fax |
|
| Email |
lucky3276@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Reshma B M |
| Designation |
Associate Professor |
| Affiliation |
Dr B R Ambedkar medical college and hospital |
| Address |
1st floor OT Complex
Department of Anesthesiology
Dr B R Ambedkar Medical College and Hospital
Shampura main road
K G Halli
Bangalore
Bangalore
KARNATAKA
560045
India |
| Phone |
8892019120 |
| Fax |
|
| Email |
lucky3276@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Thupili Poshitha Sai |
| Address |
Ot complex
Department of Anesthesiology
Dr B R Ambedkar Medical College
Shampura main road
K G Halli
Bangalore
Karnataka
India
560045 |
| Type of Sponsor |
Private 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 Thupili Poshitha Sai |
Dr B R Ambedkar medical college and hospital |
Ot complex
Department of Anesthesiology
K G Halli
Bangalore
Bangalore
KARNATAKA |
9949941347
poshithasai1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTION ETHICS COMMITTEE (IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.patients aged 18-60 years with modified Mallampati airway grade 1-2
2.patients belonging to ASA 1-3 posted for elective surgical procedures lasting for up to 120 minutes in supine position. |
|
| ExclusionCriteria |
| Details |
1. patients who refused to participate.
2. patients with difficulty airway.
3.patients posted for surgery in prone and lateral position. 4.BMI more than 30kg per m2.
5.pregnancy and lactation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the time taken for successful insertion of Igel in patients undergoing surgeries under general anesthesia. |
Time of securing the safe airway |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.to study the oropharyngeal leak
2.to study the success rate of insertion in first atempt
3.to study if any manipulations required to insert the igel like gentle withdrawal,jaw thrust,chin lift, neck flexion, head extension or change of size.
4.to study if any complications |
from the time of insertion up to 12hours |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/05/2024 |
| 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="6"
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
|
one of the best methods for airway management in patients undergoing surgery is the use of Igel. Igel is well known for its simple and ease of insertion and low complication rate.it has high oropharyngeal leak pressure and a gastric channel which reduces the risk of reflux and regurgitation. Insertion techniques contribute to successful and proper placement of Igel in first attempt, avoiding multiple attempts. Minimal handling prevents trauma to oral cavity and requires less time to secure the airway. The study is planned to assess the feasibility and efficacy of reverse technique of insertion of Igel supraglottic airway device and compare it with conventional technique. |