| CTRI Number |
CTRI/2024/11/076290 [Registered on: 05/11/2024] Trial Registered Prospectively |
| Last Modified On: |
04/11/2024 |
| 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
|
Igel insertion with two different method to check which method is better for ideal placement of Igel. |
|
Scientific Title of Study
|
A Comparative Study Of Igel Insertion Blind Vs Direct Vision Placement In Adult Patients |
| 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 Moxesh Shah |
| Designation |
Resident Doctor in Department of Anaesthesiology |
| Affiliation |
Government Medical College Vadodara |
| Address |
Resident Doctor Department of Anesthesia
Governement Medical College
Anandpura Vadodara
Vadodara
GUJARAT
390001
India |
| Phone |
8141362354 |
| Fax |
|
| Email |
smoxesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swati Bhatt |
| Designation |
Professor and Head of Department Anesthesia |
| Affiliation |
Government Medical College Vadodara |
| Address |
Department of Anesthesia
Government Medical College Vadodara
Vadodara
GUJARAT
390001
India |
| Phone |
9879372038 |
| Fax |
|
| Email |
drswatibhatt2015@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Moxesh Shah |
| Designation |
Resident Doctor in Department of Anesthesia |
| Affiliation |
Government Medical College Vadodara |
| Address |
Resident Doctor Department of Anesthesia
Government Medical College Anandpura Vadodara
Vadodara
GUJARAT
390001
India |
| Phone |
8141362354 |
| Fax |
|
| Email |
smoxesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesia Government Medical College and SSG Hospital Vadodara
District: Vadodara 390001, State: Gujarat, India
|
|
|
Primary Sponsor
|
| Name |
Government Medical College Vadodara |
| Address |
Department of Anesthesia, 2nd floor New Surgical Block, Government Medical College Vadodara and SSG Hospital Vadodara, District Vadodara 390001, State: Gujarat, India |
| 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 Moxesh Shah |
SSG Hospital Vadodara |
New Surgical Block Government Medical College Anandpura Vadodara
Vadodara
GUJARAT |
8141362354
smoxesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee for Biomedical and Health Research, Government Medical College Vadodara |
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 |
Conventional Blind Insertion of Igel. |
Patients will be kept nil by mouth (NBM) for a minimum of 8 hours. The patients will be explained about the Procedure. Operation theatre preparation for all necessary equipment and drugs will be kept ready and will be checked . Anaesthesia machine with multipara monitor to be kept ready. Equipment Checklist List: IGEL No. 3 and No. 4 Difficult Cart: Endotracheal Tubes, Nasophayngeal and Oropharyngeal Airway, Bougie, Macintosh Laryngoscope, Trupti Blade, and Fibreoptic Scope. An appropriate size I-gel will be selected, in accordance with the patient’s weight, as per manufacturer’s recommendation, and All patients will be pre-oxygenated with 100% oxygen for 3 min prior to I-gel insertion, after which IV XYLOCARD 2% 1 mg/kg IV PROPOFOL 2 mg/kg IV SCOLINE 1.5mg/kg (Given only After assessing the adequacy of bag and mask ventilation) IV ATRACURIUM 0.5 mg/kg (Loading dose), will be given after successful placement of Igel.
In group B:
Patient will be given Sniffing the Morning Air Position with Head Extension and Neck Flexion.
Igel will be Lubricated with Lignocaine Jelly on Posterior Aspect, and held firmly gliding it downwards and backwards along the hard palate using index finger with a continuous but gentle push until a definitive resistance was felt
At this point tip of Igel should be located into Upper Esophageal Opening and Cuff should be located against Laryngeal Framework. Incisors should be resting on Integral Bite Block
If there is early Resistance during Insertion a Jaw Thrust maneuver can be applied.
|
| Intervention |
Laryngoscopy Guided Insertion of Igel |
Patients will be kept nil by mouth (NBM) for a minimum of 8 hours.
The patients will be explained about the Procedure.
Operation theatre preparation for all necessary equipment and drugs will be kept ready and will be checked .
Anaesthesia machine with multipara monitor to be kept ready.
Equipment Checklist List:
IGEL No. 3 and No. 4
Difficult Cart: Endotracheal Tubes, Nasophayngeal and Oropharyngeal Airway, Bougie, Macintosh Laryngoscope, Trupti Blade, and Fibreoptic Scope.
An appropriate size I-gel will be selected, in accordance with the patient’s weight, as per manufacturer’s recommendation, and All patients will be pre-oxygenated with 100% oxygen for 3 min prior to I-gel insertion, after which
IV XYLOCARD 2% 1 mg/kg
IV PROPOFOL 2 mg/kg
IV SCOLINE 1.5mg/kg (Given only After assessing the adequacy of bag and mask ventilation)
IV ATRACURIUM 0.5 mg/kg (Loading dose), will be given after successful placement of Igel.
In group L,
Macintosh laryngoscope blade is to be inserted up to the vallecula, tongue is displaced laterally and epiglottis lifted anteriorly under vision without necessarily visualizing the vocal cords or the tracheal opening.
The lubricated I-gel is then advanced till the proximal bowl of the I-gel got positioned just below the epiglottis.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Willingness and consent for the Procedure.
Patients posted for Elective Sugeries whose Duration is between 1- 2 hour and Short Procedure requiring General Anesthesia.
Adult aged between 18-60 years and
Weight between 30-70 kg and requiring IGEL no. 3 or 4.
Patients graded with American Society of Anaesthesiologists (ASA) physical status I-II-III in preoperative assessment.
Gender: Male and Female.
|
|
| ExclusionCriteria |
| Details |
Unwillingness to Participate in Study.
Patient with uncontrolled Medical Condition like Hypertension, Diabetes Mellitus, Recent history of Ischaemic Heart Disease.
Pregnant Women.
Morbidly Obese Patient.
Patient with Difficult Airway (Small Mouth Opening, Orofacial Deformities).
Patient with Full Stomach.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Oropharyngeal Leak Pressure |
After insertion of Igel |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Ideal Positioning of IGel by Brimacombe Fibreoptic Brochoscope Scoring
Hemodynamic Parameters like Heart Rate, Systolic and Diastolic Pressure, Mean Arterial Pressure, Sp02, Etco2.
Time taken for Insertion.
Ease of Ryles Tube Insertion.
Complication like Soft Tissue Injury, Sore Throat, Blood Staining of Device, Dysphagia, Hoarseness of Voice.
|
Insertion of Igel to Removal of Igel. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
25/11/2024 |
| 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="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
|
•Malpositioning of
SAD can lead to various complications such as increased chances of aspiration,
insufficient tidal volume, air leak.
•
•
Newer trend is towards securing airway devices under vision rather than
inserting them blindly to reduce such complications..
•
•This
study is designed to compare Ideal Positioning of Igel by
Blind insertion with that of Larnygoscopy-guided insertion using Oropharyngeal Leak Pressure as Primary
Indicator. |