| CTRI Number |
CTRI/2026/02/104251 [Registered on: 18/02/2026] Trial Registered Prospectively |
| Last Modified On: |
18/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two video assisted devices(C-MAC video laryngoscope & C-MAC stylet) for safe tracheal intubation in difficult airways |
|
Scientific Title of Study
|
Comparison of C-MAC video laryngoscope and C-MAC video stylet for tracheal intubation in predicted difficult airways :A Randomised controlled trial |
| 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 Bhanu Priya |
| Designation |
Junior resident |
| Affiliation |
AIIMS DEOGHAR |
| Address |
Married pg hostel AIIMS Deoghar Devipur Jharkhand
Deoghar JHARKHAND 814152 India |
| Phone |
7667953325 |
| Fax |
|
| Email |
bhanupriya3611@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sanjay Kumar |
| Designation |
Additional Professor, Head of the department, |
| Affiliation |
AIIMS DEOGHAR |
| Address |
Room no- 602 Type 4-5 building AIIMS DeogharDevipur
Deoghar JHARKHAND 814152 India |
| Phone |
9434294265 |
| Fax |
|
| Email |
drsanjayaiims2012@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sanjay Kumar |
| Designation |
Additional Professor, Head of the department, |
| Affiliation |
AIIMS DEOGHAR |
| Address |
Room no- 602 Type 4-5 building AIIMS DeogharDevipur
Deoghar JHARKHAND 814152 India |
| Phone |
9434294265 |
| Fax |
|
| Email |
drsanjayaiims2012@gmail.com |
|
|
Source of Monetary or Material Support
|
| AII INDIA INSTUTE OF MEDICAL SCIENCE, DEOGHAR |
|
|
Primary Sponsor
|
| Name |
AII INDIA INSTUTE OF MEDICAL SCIENCE DEOGHAR |
| Address |
DEPARTMENT OF ANAESTHESIA AND CRITICAL CARE, ALL INDIA INSTITUTE OF MEDICAL SCIENCE, DEOGHAR |
| 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 BHANU PRIYA |
All India Institute of Medical Science |
Operation theater complex, All India Institute of Medical Science, Deoghar, Devipur
Deoghar
Jharkhand
Deoghar JHARKHAND |
07667953325
bhanupriya3611@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 18th IEC Subcommittee |
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 |
A |
C-MAC videolaryngoscope will be used for intubation |
| Intervention |
B |
C-MAC Videostylet will be used for intubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
• Age group 18 – 60 years old
• ASA physical status I and II
• Mallampati grade III and IV
• Mouth opening less than 3 cm
• BMI more than equal to 35 kg perm2
• Previous history of difficult intubation
|
|
| ExclusionCriteria |
| Details |
• Refusal to participate
• Mallampati grade I and II
• ASA grade more than or equal to III
• Mouth opening – Zero & more than 3cm
• Anatomical abnormality of upper airways (trauma, tumor, deformity)
• Cervical spine injury,ankylosing spondylitis
• Severe trauma during intubation
• Inability to railroad
• Inability to cooperate
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| secure airway using CMAC Videolaryngoscope vs CMAC Videostylet in difficult airway |
Time will be noted from 3 minutes after giving neuromuscular relaxant till inflation of cuff of ET tube |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Haemodynamics changes during intubation
Failure of intubation
Complication(tearing,blood on device)
Number of attempts |
1. Baseline (after 3 mins of pre-oxygenation)
2. After 1 minute of intubation
3. After 5 minutes of intubation
4. After 10 minutes of intubation |
|
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
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)
|
01/03/2026 |
| 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="6" 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
|
This trial is a randomised controlled trial in which time required to secure airway is noted in people with difficult airway. Devices used will be C-MAC video laryngoscope and C-MAC video stylet. The people fulfilling inclusion criteria will be explain and consent will be taken from them during preanaesthetic evaluation. They will be divided in to two groups A and B and randomisation will be done. Time taken for intubation will be noted. People belonging to group A will be intubated using C-MAC video stylet and people beloning to group B will be intubated using C-MAC video stylet. We are doing this trial to make use of new devices for difficult intubation to avoid delayed intubation, complication, hypoxia caused due to inability to secure airway in difficult airway. Anaesthetist intubating must be experinced for 3 years. |