| CTRI Number |
CTRI/2025/07/092086 [Registered on: 31/07/2025] Trial Registered Prospectively |
| Last Modified On: |
31/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparative Study Between Hugemed Flexible Video Laryngoscope Versus C Mac Video Laryngoscope For Efficacy Of Tracheal Intubation.
|
|
Scientific Title of Study
|
A Comparative Evaluation Between Hugemed Flexible Video Laryngoscope Versus C Mac Video Laryngoscope For Efficacy Of Tracheal Intubation In Anticipated Difficult Intubation. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bushra Fatma |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru medical College, Aligarh Muslim University. |
| Address |
Department of Anesthesiology and Critical care, Jawaharlal Nehru medical College and hospital , Aligarh Muslim University, Aligarh.
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8273180113 |
| Fax |
|
| Email |
fatbushra213@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Qazi Ehsan Ali |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru medical College, Aligarh Muslim University |
| Address |
Department of Anesthesiology and Critical care, Jawaharlal Nehru medical College, Aligarh Muslim University, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
7417701769 |
| Fax |
|
| Email |
qaziehsanali@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Qazi Ehsan Ali |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru medical College, Aligarh Muslim University |
| Address |
Department of Anesthesiology and Critical care, Jawaharlal Nehru medical College, Aligarh Muslim University, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
7417701769 |
| Fax |
|
| Email |
qaziehsanali@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology and Critical care, Jawaharlal Nehru medical College Aligarh Muslim University , Aligarh.Uttar Pradesh 202002. |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesiology and Critical care Jawaharlal Nehru medical College and hospital |
| Address |
Department of Anesthesiology and Critical care, Jawaharlal Nehru medical College and hospital, Aligarh Muslim University, Aligarh.Uttar Pradesh ,202002.
India
202002 |
| 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 Bushra Fatma |
Jawaharlal Nehru medical College and hospital. |
Department of Anesthesiology and Critical care .
Aligarh
UTTAR PRADESH |
08273180113
fatbushra213@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics, Jawaharlal Nehru medical College Aligarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
C MAC Video Laryngoscope For Efficacy Of Successful Tracheal Intubation In Anticipated Difficult Intubation. |
C Mac Video Laryngoscope,Time Required for Successful Tracheal Intubation. |
| Intervention |
Hugemed Flexible Video Laryngoscope For Efficacy Of Successful Tracheal Intubation In Anticipated Difficult Intubation. |
Hugemed Flexible Video Laryngoscope Time Required For Successful Tracheal Intubation In Anticipated Difficult Intubation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients Planned For Elective Surgery Under General Anaesthesia.
Predicted Difficult Laryngoscopy And Intubation With Mallampati Grade 3 or 4. |
|
| ExclusionCriteria |
| Details |
Patients With Obstructing Laryngeal Lesion Such As Cancer.
Patients With Laryngeal or Craniofacial Trauma.
Mouth Opening Less Than 2.5
Mallampati Grade 1 and 2 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time Required For Efficacy Of Successful Tracheal Intubation. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
11/08/2028 |
| 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 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
|
Tracheal intubation is a critical skill in managing unconscious or anesthetized patients and can become challenging, especially in cases involving difficult airways. Complications such as hypoxemic brain injury and airway trauma may occur if intubation is not performed efficiently. While fiberoptic bronchoscopy remains the gold standard for managing difficult airways, video laryngoscopes have emerged as valuable alternatives. The C-MAC video laryngoscope, with its Macintosh-style blade and integrated video camera, offers the dual advantage of being used both as a direct and a video laryngoscope. The Hugemed Flexible Video Laryngoscope, on the other hand, offers greater maneuverability, especially in anatomically difficult airways.The primary objective of the study is to compare the number of attempts required for successful intubation, while secondary objectives include time taken for intubation, laryngeal view, ease of device insertion, hemodynamic changes, and adverse events. Standardized premedication and induction protocols will be followed. The study aims to determine which device offers greater efficacy and safety, thereby guiding anesthesiologists in managing anticipated difficult airways more confidently and effectively. |