| CTRI Number |
CTRI/2025/08/092331 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of device i-gel plus as a conduit to perform fibreoptic intubation in adults |
|
Scientific Title of Study
|
Evaluation of i-gel plus as a conduit for fiberoptic intubation in adults : An observational 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 Divyashri Chaukhe |
| Designation |
Post Graduate Student |
| Affiliation |
Maulana Azad Medical College and associated Lok Nayak Hospital |
| Address |
3rd floor,BL Taneja block, Department of Anaesthesiology and intensive care,Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
9822230349 |
| Fax |
|
| Email |
divyashrichaukhe16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neelam Prasad |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College and associated Lok Nayak Hospital |
| Address |
3rd floor, BL Taneja Block, Department of Anaesthesiology and Intensive Care, Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
9968604372 |
| Fax |
|
| Email |
nprasadgovil@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divyashri Chaukhe |
| Designation |
Post Graduate Student |
| Affiliation |
Maulana Azad Medical College and associated Lok Nayak Hospital |
| Address |
3rd floor, BL Taneja Block, Department of Anaesthesiology and intensive care, Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
9822230349 |
| Fax |
|
| Email |
divyashrichaukhe16@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and associated Lok Nayak Hospital, Bahadurshah Zafar Marg,New Delhi 110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College and associated Lok Nayak Hospital |
| Address |
Maulana Azad Medical College and associated Lok Nayak Hospital, Bahadurshah Zafar Marg, New Delhi 110002 |
| 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 Divyashri Chaukhe |
Lok Nayak Hospital |
BL Taneja block, Department of Anaesthesiology, Maulana Azad Medical College
Central
DELHI |
9822230349
divyashrichaukhe16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad 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 |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group 18-60 years of either gender.2. American Society of Anaesthesiologists Grade I and II patients. 3.Patients assessed to have El-Ganzouri score(EL.GA)smaller than 4 |
|
| ExclusionCriteria |
| Details |
1.Surgical procedure involving oral cavity or prone position
2.Pregnant women
3.Risk of aspiration pneumonitis with history of gastro-oesophageal reflux
4.Obesity (BMI greater than or equal to 30)
5.Any Airway pathology |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time required for fibreoptic intubation (FOI) using i-gel plus (in minutes) |
baseline at time of intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time taken for i-gel plus insertion (in minutes/seconds)
|
baseline [time taken for igel plus insertion] |
| Number of attempts required for successful intubation using i-gel plus |
|
| Grade of ease of insertion of i-gel plus |
|
| Brimacombe score for fibreoptic view of glottis |
|
| Upward flexion angle of fibrescope tip to achieve grade 4 of Brimacombe score for i-gel plus using protractor (in degrees) |
|
| Time taken for i-gel plus removal with ETT in place(in minutes/seconds) |
after intubation |
| Assess complications after removal of i-gel plus and ETT |
|
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
18/08/2025 |
| 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
|
We are evaluating device i-gel plus as a conduit for fibreoptic intubation in adults in patients undergoing general anaesthesia in Lok Nayak hospital, Delhi after meeting inclusion criteria. A total of 35 patients will be enrolled for the study. Patients will be explained about the study and written informed consent will be taken. Size of i-gel plus will be selected according to weight of patient and fibreoptic bronchoscope will be inserted. ETT will be railed over fibrescope using i-gel plus as a conduit. After confirmation of proper ventilation i-gel plus will be removed keeping ETTin place. We will be using standard general anaesthesia for induction of patients and time taken for fibreoptic intubation will be noted. Along with it Brimacombe score for glottic view, ease of insertion of i-gel plus, number of attempts required for successful intubation, complications will also be noted. |