| CTRI Number |
CTRI/2025/09/094604 [Registered on: 11/09/2025] Trial Registered Prospectively |
| Last Modified On: |
11/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparing a special video camera tool and a regular tool used to help put an Endotracheal tube in a simulated difficult airway situation. |
|
Scientific Title of Study
|
Comparison of MAC Style Video Laryngoscope and MacIntosh Laryngoscope for Endotracheal Intubation in a simulated 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 |
Dr Praveen kumar |
| Designation |
Post graduate resident |
| Affiliation |
School of medical sciences and research Sharda university |
| Address |
Department of Anaesthesiology School of medical sciences and research Sharda university Greater Noida Gautam Buddha Nagar Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
7017083510 |
| Fax |
|
| Email |
kushwaha.pk2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shiv kumar singh |
| Designation |
Professor |
| Affiliation |
School of medical sciences and research Sharda university |
| Address |
Department of Anaesthesiology School of medical sciences and research Sharda university Greater Noida Gautam Buddha Nagar Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9650943359 |
| Fax |
|
| Email |
shiv.singh@sharda.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Praveen kumar |
| Designation |
Post graduate resident |
| Affiliation |
School of medical sciences and research Sharda university |
| Address |
Department of Anaesthesiology School of medical sciences and research Sharda university Greater Noida Gautam Buddha Nagar Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
7017083510 |
| Fax |
|
| Email |
kushwaha.pk2@gmail.com |
|
|
Source of Monetary or Material Support
|
| School of Medical Sciences and Research Sharda Hospital Greater Noida Gautam Buddha Nagar Uttar Pradesh 201306 |
|
|
Primary Sponsor
|
| Name |
School of Medical Sciences and Research Sharda Hospital |
| Address |
School of Medical Sciences and Research Sharda Hospital Greater Noida Gautam Buddha Nagar Uttar Pradesh 201306 |
| 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 Praveen kumar |
School of medical sciences and research Sharda university |
Department of Anaesthesiology School of Medical Sciences and Research Sharda University Gautam Buddha Nagar 201306
Gautam Buddha Nagar
UTTAR PRADESH |
7017083510
kushwaha.pk2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee School of Medical Sciences and Research Greater Noida |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MAC Style video Laryngoscope |
MV Group: In this group the patients will be intubated with using MAC Style video Laryngoscope |
| Comparator Agent |
MacIntosh Laryngoscope
|
ML Group: In this group patients will be intubated with using McIntosh Laryngoscope |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 18-65 years of either sex
2. ASA grade I and II
3. Elective surgery under general anaesthesia requiring endotracheal intubation
4. Patients willing to be part of the study
5. Patients having Airway Mallampati grade I or grade II
6. Patients with El-Ganzouri Risk Index Score less than or equals to 7
7. Patient having BMI less than 30 kg/m2
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal to participate in the study
2. Patient having any risk of gastric aspiration
3.Patients undergoing oropharyngeal surgery
4.Patient with known unstable cervical spine injury
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the visualisation of the laryngeal inlet in the two groups |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the intubation time in the two groups
2. To compare the need for use of bougie or external laryngeal manipulation in the two groups
3. To compare overall intubation success rate in the two groups
4. To compare the complications in the two groups
5. To compare the ease of intubation in the two groups
|
Baseline |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
25/09/2025 |
| 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="6"
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
|
This Randomized single blinded comparative study aims to Compare between MAC style video Laryngoscope and MacIntosh Laryngoscope for Endotracheal intubation in a simulated difficult airway under General Anaesthesia. A total of 110 Patients of ASA Grade I and II will be selected based on Inclusion and Exclusion Criteria aged between 18 to 65 years and will be randomly assigned into two groups ML and MV. Each group will have 55 Patients. Group ML: Patients will be in intubated using MacIntosh Laryngoscope. Group MV: Patients will be intubated using MAC Style Video Laryngoscope. Primary Objective is to compare visualization of the Laryngeal inlet in the two groups. Secondary objectives are to compare the intubation time in two groups, To compare the need for use of bougie or external laryngeal manipulation in the two groups, To compare overall intubation success rate in the two groups, To compare the complications in the two groups, to compare ease of intubation in the two groups The study will be Conducted in Sharda Hospital, Greater Noida Over 18 Months. |