| CTRI Number |
CTRI/2024/08/072808 [Registered on: 21/08/2024] Trial Registered Prospectively |
| Last Modified On: |
21/08/2024 |
| 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
|
Airway spatula helps for insertion of I-gel Supraglottic airway device during anesthesia |
|
Scientific Title of Study
|
Insertion of I-gel by the airway spatula technique improves the success rate and reduces the time taken for its placement: A prospective, randomized, controlled , interventional 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 Swathi S |
| Designation |
Senior resident |
| Affiliation |
JSS university Mysuru, Karnataka state, India |
| Address |
Department of Anesthesiology
JSS hospital
Mysore district
Karnataka
Mysore
KARNATAKA
570004
India |
| Phone |
8660671614 |
| Fax |
|
| Email |
drswathi.20111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swathi S |
| Designation |
Senior resident |
| Affiliation |
JSS university Mysuru, Karnataka state |
| Address |
Department of Anesthesiology
JSS hospital
Mysore district
Mysore
KARNATAKA
570004
India |
| Phone |
8660671614 |
| Fax |
|
| Email |
drswathi.20111@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swathi S |
| Designation |
Senior resident |
| Affiliation |
JSS university Mysuru Karnataka state, India |
| Address |
Department of Anesthesiology
JSS hospital
Mysore
Mysore
KARNATAKA
570004
India |
| Phone |
8660671614 |
| Fax |
|
| Email |
drswathi.20111@gmail.com |
|
|
Source of Monetary or Material Support
|
| Operation theatre complex, Department of Anesthesiology, 3rd floor, JSS hospital, Mahathma Gandhi road, Mysore district 570004, Karnataka state, India |
|
|
Primary Sponsor
|
| Name |
Dr Swathi S |
| Address |
OT complex, 3rd floor, Department of Anesthesiology,
JSS hospital
Mysore district 570004
Karnataka state
India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Vinoth Kumar |
Operation theatre complex, 3rd floor,
Assistant professor,
Department of Anesthesiology,
JSS hospital,
Mysore district 570004
Karnataka state,
India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Swathi S |
JSS hospital Mysore |
Operation theatre Complex, 3rd floor,
Department of Anesthesiology,
Mahathma Gandhi road
Mysore
KARNATAKA |
8660671614
drswathi.20111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS MEDICAL COLLEGE |
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 |
I-gel (Supraglottic airway) insertion using airway spatula |
I-gel will be introduced with the help of airway spatula. Insertion time and ease of insertion will be measured.
|
| Intervention |
I-gel (Supraglottic airway) insertion without using airway spatula |
I-gel will be introduced without the help of airway spatula(standard method). Insertion time and ease of insertion will be measured. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients scheduled to undergo surgeries for duration up to 2 hours, using a SAD
2. adults of both sex (18–50 years)
3.Modified Mallampati airway grade 1–2.
|
|
| ExclusionCriteria |
| Details |
Patients posted for emergency surgery
Patients with gastroesophageal reflux disease
Obese patients
For surgeries in prone position
Surgery duration more than 2hours |
|
|
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 |
| Possible outcome of the study: Airway spatula reduces the insertion time of I-gel. |
At induction of anesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not applicable |
not applicable |
|
|
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)
|
16/09/2024 |
| 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="0"
Months="3"
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
|
The igel represents a revolutionary advancement in airway management offering a safe and effective alternative to traditional endotracheal intubation.In 2020 Arimanickam conducted a study in the manikin using kings vision video laryngoscope concluded that airway spatula helped in easy and atraumatic introduction of rigid scope into patients mouth and they also hypothesized it can be used to insert laryngeal mask airways .Hence study is designed to monitor the effect of airway spatula for igel insertion |