| CTRI Number |
CTRI/2026/01/100405 [Registered on: 06/01/2026] Trial Registered Prospectively |
| Last Modified On: |
05/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of successful intubation under general anaesthesia through a device called i-gel Plus in patients who will undergo anaesthesia and has no contraindication for the device insertion. |
|
Scientific Title of Study
|
Evaluation of first pass success rate of intubation through i-gel Plus in anesthetized patients without anticipated difficult airway |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shweta Sinha |
| Designation |
Associate professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Kasturba Medical College
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9113041764 |
| Fax |
|
| Email |
shweta.sinha@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Shweta Sinha |
| Designation |
Associate professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Kasturba Medical College
Manipal
KARNATAKA
576104
India |
| Phone |
9113041764 |
| Fax |
|
| Email |
shweta.sinha@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Shweta Sinha |
| Designation |
Associate professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Kasturba Medical College MAHE
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9113041764 |
| Fax |
|
| Email |
shweta.sinha@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College
Manipal Academy of Higher Education, Manipal , Udupi
Karnataka 576104 |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College |
| Address |
Kasturba Medical College, Manipal 576104 |
| 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 Shweta Sinha |
Departrment Of Anaesthesia |
Kasturba Medical College Manipal
Udupi
KARNATAKA |
9113041764
shweta.sinha@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba medical college and Kasturba hospital Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R198||Other specified symptoms and signsinvolving the digestive system and abdomen, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intubation through igel Plus in anesthetized patients without anticipated difficult airway |
To assess the safety and feasibility of endotracheal intubation using the i-gel Plus® as a conduit and to determine the first-pass success rate of endotracheal intubation using the i-gel Plus®
To evaluate the ease, attempts, time and success of device placement
To evaluate complications like sore throat, blood staining of the device, and laryngospasm.
|
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age between 18 to 60 years
Patients with American Society of Anesthesiologists physical status I and II requiring general anesthesia with endotracheal intubation
|
|
| ExclusionCriteria |
| Details |
Patient refusal
Patients with predictors of difficult bag and mask ventilation
Patients with predictors of difficult supraglottic airway device placement
Patients with predictors of difficult laryngoscopy
Patients with an anticipated difficult airway with a Wilson score more than 5 as assessed in preoperative airway examination
Patients with increased risk of aspiration, such as morbid obesity and pregnancy
Patients with body mass index BMI more than 30
Patients with obstructive airway pathology and reactive airway disease
Patients undergoing airway surgeries
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the first pass success rate of intubation through i-gel Plus® |
0min
1min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Fibreoptic grade of visualization of the glottis, ease, time, attempts & success of device placement, time for successful endotracheal intubation, & complications if noted |
0min
1min |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
19/01/2026 |
| 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
|
Effective airway
management is a cornerstone of anaesthesia, with successful intubation on the
first attempt being associated with reduced complications such as hypoxia,
trauma and haemodynamic stability. Recently, supraglottic airway devices
(SGADs) with a conduit for tracheal intubation are gaining popularity as a
bridge between ventilation and intubation in all patient populations.
Furthermore, endotracheal intubation using SGAD is a widely investigated and
accepted technique that has been recognised on the emergency pathway of the
American Society of Anaesthesiologists’ Difficult Airway Algorithm.
The i-gel Plus (Intersurgical Ltd) is an improved
version of i-gel with additional features incorporated in the device, such as a
supplementary oxygen port for the administration of passive oxygenation as a
component of cardiocerebral resuscitation (CCR), a larger gastric channel, an
intubation ramp and a longer non-inflatable cuff tip for improving
oropharyngeal leak pressure.The intubation ramp provided in the bowl of the
non-inflatable cuff helps to ensure an optimal angle of the tracheal tube as it
exits the device, allowing reliable and safe passage through the vocal cords
into the trachea. Direct laryngoscopy and intubation can induce sympathetic
stimulation and potential haemodynamic responses like hypertension and
tachycardia. This negative physiological response can be mitigated by
intubation through a supraglottic device such as the i-gel plus. However, the
clinical performance of i-gel plus is underexplored. Recently, a cadaveric
study demonstrated that i-gel plus acts as a superior conduit for fibreoptic
intubation than standard i-gel. Its performance as an intubation conduit has
not been studied in patients. Hence, we plan to evaluate the safety,
feasibility and first pass success rate of endotracheal intubation through
i-gel plus |