| CTRI Number |
CTRI/2020/09/028011 [Registered on: 24/09/2020] Trial Registered Prospectively |
| Last Modified On: |
24/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
This study is to see the effects of three types of Laryngoscopes in patients undergoing general anesthesia for spine problem. |
|
Scientific Title of Study
|
Comparison of C-MAC video-laryngoscope with D-Blade, C-MAC video-laryngoscope with standard blade, and Macintosh Laryngoscopes for intubation with cervical spine immobilization: a randomized study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Niraj Kumar |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room no – 709
7th floor
Deptt of Neuroanesthesiology and Critical Care
Neuroscience center
AIIMS New Delhi.
New Delhi DELHI 110029 India |
| Phone |
9013770806 |
| Fax |
|
| Email |
drnirajaiims@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Niraj Kumar |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room no – 709
7th floor
Deptt of Neuroanesthesiology and Critical Care
Neuroscience center
AIIMS Delhi
New Delhi DELHI 110029 India |
| Phone |
9013770806 |
| Fax |
|
| Email |
drnirajaiims@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Niraj Kumar |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room no – 709
7th floor
Deptt of Neuroanesthesiology and Critical Care
Neuroscience center
AIIMS Delhi
New Delhi DELHI 110029 India |
| Phone |
9013770806 |
| Fax |
|
| Email |
drnirajaiims@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
Ansari Nagar, New Delhi. 110029 |
| Type of Sponsor |
Research institution |
|
|
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 Niraj Kumar |
AIIMS, New Delhi |
Dr Niraj Kumar
Room no – 709 7th floor Deptt of Neuroanesthesiology & Critical Care Neuroscience center AIIMS Delhi-110029 New Delhi DELHI |
9013770806
drnirajaiims@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Cervical Myelopathy, (1) ICD-10 Condition: G00-G99||Diseases of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
C-MAC video-laryngoscope with D-Blade, C-MAC video-laryngoscope with standard blade |
In group 2, C-MAC video-laryngoscope with standard blade and in group 3, C-MAC video-laryngoscope with D-Blade will be used for endotracheal intubation. |
| Comparator Agent |
Macintosh Laryngoscope |
In group 1(control) Macintosh Laryngoscope will be used for endotracheal intubation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged between 18 and 60 years of either gender belonging to ASA physical status I–II undergoing elective cervical spine surgery requiring GA |
|
| ExclusionCriteria |
| Details |
Patients with risk factors for difficult mask ventilation
Patients with risk factors for gastric aspiration (obesity)
Patients with difficult airway such as previous neck surgery and mouth opening less than 3 cm will be excluded from the study.
Anticipated difficult airway including Mallampati grade 3 and 4 airway
|
|
|
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 |
| Cormack Lehane (CL) grade of laryngoscopic view |
at the point when blade of the laryngoscope is placed inside the mouth |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time taken for successful intubation
Success rate of first attempt intubation
No of attempts of intubation
Number of optimization manoeuvres required
Complications
Difficulty score laryngoscope blade will be noted
Hemodynamic changes
|
-time from insertion of the laryngoscope blade until first appearance of the capnograph waveform
Hemodynamic changes - (before induction, after induction, immediately after intubation than every minute until 5 min after intubation).
|
|
|
Target Sample Size
|
Total Sample Size="123" Sample Size from India="123"
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)
|
01/10/2020 |
| 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)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Title: Comparison of C-MAC video-laryngoscope with D-Blade, C-MAC video-laryngoscope with standard blade, and Macintosh Laryngoscopes for intubation with cervical spine immobilization: a randomized study.
Macintosh laryngoscope is the most commonly used device for intubation in anesthesia practice. Difficult intubation still a major cause of morbidity and mortality associated with anaesthesia. Recently, viedeolaryngoscopes are becoming very popular for difficult intubation management because it increases glottic view and the success of intubation. There are many studies which show C-MAC viedeolaryngoscopes improves laryngeal view compared to direct laryngoscopy. Manual in-line stabilization (MILS) is used during procedures like airway management in patients with C-spine injury to minimize cervical movement. But MILS make the intubation difficult by decreasing the view of laryngoscopy. A new C-MAC D-Blade is introduced which can be used as an alternative in difficult airway situations. The advantage of the C-MAC video-laryngoscope with a D-Blade in presence of cervical spine immobilization is not known. The purpose of this randomized controlled study is to comÂpare the C-MAC video-laryngoscope with D-Blade, C-MAC video-laryngoscope with a standard blade, and Macintosh Laryngoscopes for intubation for endotracheal intubation under general anaesthesia with manual in-line stabilization (MILS).
The primary objective is to compare the Cormack Lehane (CL) grade of laryngoscopic view between C-MAC video-laryngoscope with D-Blade, C-MAC video-laryngoscope with standard blade, and Macintosh Laryngoscopes in patients undergoing general anesthesia (GA) using MILS. Following approval of Institute Ethics Committee, 123 patients in between the age group of 18-60 years, will be enrolled in a prospective, randomized, parallel group, multiple arm trial study. Patients aged between 18 and 60 years of either gender belonging to ASA physical status I–II undergoing elective cervical spine surgery requiring GA will be included.
The patients will be randomized to one of the following three groups (41 each) on the basis of a computer-generated randomization chart: Group I: Macintosh laryngoscope (Group M), Group II: C-MAC videolaryngoscope (Group C), Group III: C-MAC D video laryngoscope (Group D).
All patients enrolled for the study will receive general anesthesia with tracheal intubation. The neck will be immobilized using MILS by holding the sides of the neck and the mastoid processes, thus preventing flexion/extension or rotational movements of head and neck. Cormack Lehane (CL) grade will be assessed after the first attempt of laryngoscopy. Primary outcome measure will be Cormack Lehane (CL) grade of laryngoscopic view. The secondary outcome will be time taken for successful intubation, success rate of first attempt intubation, number of attempts of intubation, number of optimization maneuvers required to aid tracheal intubation, complication, difficulty score and Hemodynamic changes during the intubation process. |