| CTRI Number |
CTRI/2024/07/071010 [Registered on: 22/07/2024] Trial Registered Prospectively |
| Last Modified On: |
02/08/2024 |
| 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
|
Study comparing the reverse and standard methods of I-gel insertion. |
|
Scientific Title of Study
|
Comparative study of two different methods of I-gel insertion:Reverse versus Standard technique.
|
| 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 Sharan V |
| Designation |
Postgraduate resident in anaesthesiology |
| Affiliation |
B.J.Medical college and Civil Hospital ,Ahmedabad |
| Address |
F3,First floor,Department of anaesthesiology,Civil hospital,Asarwa,Ahmedabad,
Gujarat
Ahmadabad
GUJARAT
380016
India |
| Phone |
9342368383 |
| Fax |
|
| Email |
sharanmourty@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrNamrata A Shah |
| Designation |
Associate professor (H.G) |
| Affiliation |
B.J.Medical college and Civil Hospital ,Ahmedabad |
| Address |
F3,First floor,Department of anaesthesiology,Civil hospital,Asarwa,Ahmedabad,
Gujarat
Ahmadabad
GUJARAT
380016
India |
| Phone |
9825521519 |
| Fax |
|
| Email |
drnamrata99@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DrNamrata A Shah |
| Designation |
Associate professor (H.G) |
| Affiliation |
B.J.Medical college and Civil Hospital ,Ahmedabad |
| Address |
F3,First floor,Department of anaesthesiology,Civil hospital,Asarwa,Ahmedabad,
Gujarat
Ahmadabad
GUJARAT
380016
India |
| Phone |
9825521519 |
| Fax |
|
| Email |
drnamrata99@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
Primary Sponsor
Modification(s)
|
| Name |
Government of Gujarat |
| Address |
7th floor ,Health and family welfare department,Sachivalay,
Gandhinagar |
| 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 Sharan V |
BJ Medical College and civil hospital Ahmedabad |
Department of Anaesthesia ,
major surgery OT,
fifth floor ,
trauma building ,
civil hospital ,asarwa
Ahmedabad ,Gujarat ,380016
Ahmadabad
GUJARAT |
9342368383
sharanmourty@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee,B.J Medical College and Civil Hospital,Ahmedabad |
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 |
GROUP S [Standard method of insertion of I-GEL] |
In Standard group,after giving the patient sniffing position,i-gel will be inserted with the concavity of i-gel facing the mandible using a pen holding grip and inserting the device till fitting over the larynx |
| Comparator Agent |
GROUP R [reverse rotational method of insertion of I-GEL] |
In Group R, I- gel is introduced into the mouth with concavity facing palate. On reaching oropharynx, then i-gel is rotated 180 degree counterclockwise and pushed to its final position till it is fitted over the larynx. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Planned surgeries of either sex of duration of up to 2 hrs
2.Patients aged 18 to 60 years
3.ASA Grade I, II,
4.Scheduled for surgeries under general anaesthesia with duration of up to 2 hour.
5.Modified mallampatti airway grade I and II
|
|
| ExclusionCriteria |
| Details |
1.Patients taken for emergency surgeries.
2.Patients of any pathology of neck, upper respiratory tract or upper alimentary tract
3.ASA grade III,IV
4.Patients with mouth opening less than 2.5 cm
5.Patients with history of obstructive sleep apnea, pregnancy, hepatic, cardiac, renal abnormality, alcoholism, smokers, diabetes, significant GERD, Obesity, thoracic,Neuro and Cardiac surgeries, Surgery in prone position
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the First attempt insertion success rate
in standard method of i-gel insertion and reverse rotational method of i- gel insertion
|
Till successful insertion of I-gel and starting of mechanical ventilation .
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the Number of attempts for successful insertion, Number of manipulations required for successful insertion, hemodynamic changes occurring post insertion and Post operative complications
|
First 24 hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
23/07/2024 |
| 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 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
|
Supraglottic airway devices (SAD’s ) offers an excellent non invasive option for ventilation in patients undergoing various surgeries and in pre hospital emergencies. They also help in providing a rescue access in patients with difficult intubation.I-gel is a second generation SAD that features a non inflatable anatomically shaped cuff which provides a acceptable airway seal. It has some advantages over endotracheal intubation, such as quick and ease of placement, devoid hemodynamic response of laryngoscopy, lesser requirement for neuromuscular blockade and a lower incidence of postoperative morbidity like laryngospasm, cough at removal, dysphagia, dysphonia . I-gel is conventionally placed with its concave curvature facing the mandible like the LMA. But the bulky design of the I-gel may be hindered by the tongue size while insertion through conventional technique thereby obstructing its passage to the pharynx. This tends to longer time and increasing number of attempts for insertion of I-gel.This study is designed to compare the efficacies of two insertion techniques Standard vs Reverse technique for I-gel placement in terms of success rate ,insertion time and incidence of post op complications.
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