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CTRI Number  CTRI/2025/08/093308 [Registered on: 20/08/2025] Trial Registered Prospectively
Last Modified On: 19/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study comparing Intubation Difficulty Scale in two neck protection methods like neck collar and neck stabilisation by a person during breathing tube insertion using video device in patients under anaesthesia 
Scientific Title of Study   C-MAC-Guided tracheal intubation in simulated cervical spine immobilisation : A Randomised Controlled Trial comparing Semi-Rigid Cervical Collar and Manual In-Line Stabilisation 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bonthu Chandra Sai Prathyusha 
Designation  Junior Resident  
Affiliation  All India Institute of Medical Science,New Delhi 
Address  Dept of Anaesthesiology,Pain Medicine and Critical Care, 5th floor, Academic Block, AIIMS, Ansari Nagar

New Delhi
DELHI
110029
India 
Phone  7013433296  
Fax    
Email  saiprathyusha.naidu@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sharmishtha Pathak 
Designation  Assistant Professor  
Affiliation  All India Institute of Medical Science,New Delhi 
Address  Dept of Anaesthesiology,Pain Medicine and Critical Care, Room No.122, 1st floor, Jai Prakash Narayan Apex Trauma Centre , AIIMS, Raj Nagar

New Delhi
DELHI
110029
India 
Phone  9168378780  
Fax    
Email  sharmishtha.pathak@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sharmishtha Pathak 
Designation  Assistant Professor  
Affiliation  All India Institute of Medical Science,New Delhi 
Address  Dept of Anaesthesiology,Pain Medicine and Critical Care, Room No.122, 1st floor, Jai Prakash Narayan Apex Trauma Centre , AIIMS, Raj Nagar

New Delhi
DELHI
110029
India 
Phone  9168378780  
Fax    
Email  sharmishtha.pathak@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Science,Sri Aurobindo Marg, Ansari Nagar East, New Delhi, 110029 
 
Primary Sponsor  
Name  All India Institute of Medical Science,New Delhi 
Address  Department of Anaesthesiology, 5th floor, Academic block,Ansari Nagar New Delhi 110029 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bonthu Chandra Sai Prathyusha  All India Institute of Medical Science, New Delhi  Department of Anaesthesiology,5th floor, Academic block
New Delhi
DELHI 
7013433296

saiprathyusha.naidu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, All India Institute of Medical Science, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: V224||Motorcycle driver injured in collision with two- or three-wheeled motor vehicle in traffic accident,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Manual in-line Stabilisation (MILS)  MILS is a manual technique for cervical spine immobilisation.After induction of anaesthesia, an assistant will apply MILS by holding the patient’s head with both hands to restrict neck movement. Head and neck will be kept in neutral position throughout the intubation attempt. Tracheal intubation will be performed using the CMAC video laryngoscope during stabilisation. MILS will be done to simulate spinal motion restriction during airway management. 
Intervention  Semi-rigid Cervical Collar  Semi-rigid Cervical Collar is a device-based cervical spine immobilisation.A well-fitting semi-rigid cervical collar (Tomson cervical collar, TOMSON MEDICARE PVT. LTD) will be adjusted to correct size and applied according to the manufacturer’s instructions around the participant’s neck after induction of general anaesthesia to simulate cervical spine immobilisation.The collar restricts neck flexion, extension, and rotation.Tracheal intubation will be performed using a CMAC video laryngoscope without removing the collar. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.American Society of Anaesthesiology (ASA) Grades I to III.
2.Body mass index (BMI) between 18 and 30kg/m2.
3.Mallampati grade of 1 or 2.
4.Patients undergoing non-emergent surgery under General Anaesthesia.
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Comparison of Intubation Difficulty Scale (IDS) score between two groups  At the time of intubation  
 
Secondary Outcome  
Outcome  TimePoints 
To compare time for successful intubation   At the time of intubation 
To compare ease of insertion of C-MAC  At the time of intubation  
To assess first-attempt success rate  At the time of intubation  
To assess difficult bag and mask ventilation   At the time of mask ventilation  
To compare the use of intubation aid
1)Bougie
2)External laryngeal pressure  
At the time of intubation  
To assess hemodynamic changes during intubation
1)BP
2)Pulse rate
3)SpO2 
Baseline
1 minute after induction
1 minute before intubation
1 minute after intubation  
To assess complications
1)Dental trauma
2)Airway Mucosal injury 
At the time of intubation  
To assess intubation failure  At the time of intubation  
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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 3 
Date of First Enrollment (India)   01/09/2025 
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  

Patients with known or suspected cervical injury may require emergent intubation for airway protection and ventilatory support or elective intubation for surgery. Airway management in cervical spine injuries requires a careful approach to minimize further spinal cord damage during intubation. The crucial step in airway management of patients with suspected or confirmed cervical spine injury in the emergency department or operation theater is to prevent any neurological injury during laryngoscope and tracheal intubation. Cervical spine immobilization is of utmost importance to prevent further exacerbation of neurological damage. Several techniques and devices have been developed to optimize intubation in these patients, each with its own set of advantages and limitations.

The study aims to compare the ease of intubation using the C-MAC video laryngoscope in simulated cervical spine immobilisation using either: Semi-rigid Cervical collar or Manual in-line Stabilisation          

Primary objective:

To compare the intubation characteristics using intubation difficulty scale (IDS) between Semi-rigid cervical collar and MILS using C-MAC in patients undergoing non-emergent surgeries in trauma centre.

Methodology

In the pre-anaesthetic checkup, thorough airway examination including mouth opening, inter-incisor distance, modified Mallampati class, thyromental distance, sternomental distance, neck mobility will be assessed. Patients will be kept fasting for 8 hours. Age, gender, weight, height, airway parameters, and name of the surgery will be noted.On the day of surgery, after confirming the patient fasting status and consent form, patients will be placed supine on operating table with the head and neck being maintained in neutral position as confirmed by direct visualisation. ASA recommended standard monitors including pulse oximetry, capnograph, three lead ECG and non-invasive blood pressure will be attached to the patients. Baseline heart rate, non-invasive blood pressure, SpO2 will be recorded. An appropriate gauge IV line will be secured as per the attending anaesthesiologist in the OT.

Patients will be pre-oxygenated with 100% oxygen and induced using intravenous fentanyl 2mcg/kg, propofol 2-2.5mg/kg. After confirming adequate bag-mask ventilation, muscle relaxation will be done using rocuronium 1mg/kg. Cervical spine immobilisation will be achieved by using either cervical collar or MILS. A well-fitting cervical collar (Tomson cervical collar, TOMSON MEDICARE PVT. LTD) will be adjusted to correct size and applied according to the manufacturer’s instructions in one group of patients. MILS will be applied by experienced anaesthesiologist who had performed >30 MILS in another group of patients. Stabilise the patients head in a neutral position by removing the pillow, so that the patient’s shoulders and occiput are rested on the operation table in another group of patients. Both mastoid processes will be grasped by the thumb and palms will be placed on either side of the head, and the occiput will be held firmly in the hands by the fingers to avoid axial traction by applying force equal and opposite to that created by the intubating anaesthesiologist.

 Bag and mask ventilation will be performed for 3 minutes. Difficulty in mask ventilation requiring a 2-hand technique or change of operator or guedul airway requirement (oropharyngeal airway) will be noted. During bag and mask ventilation, tidal volume delivered to the patient, chest rise, SpO2, end tidal CO2 will be noted.Then, intubation will be attempted with CMAC video laryngoscope of appropriate blade size depending on the patient (either 3 or 4) by anaesthetist who has experience using CMAC at least 30 times. After opening the mouth, CMAC will be inserted, and the glottis view will be measured according to POGO and Cormack Lahane grading. An independent person will start timer. Intubation time will be recorded from insertion of the CMAC to confirmation of end-tidal CO2.An appropriately sized (females with 7 or 7.5 and males with 8 or 8.5) cuffed endotracheal tube (ETT) along with stylet will be introduced into glottis opening. Successful intubation will be confirmed when EtCO2 is detected using capnography. CMAC will be removed from the patient’s mouth and cuff of ETT will be inflated. Intubation difficulty score will be noted by the intubating anaesthesiologist.

During the intubation process, the attempt will be terminated if the saturation of peripheral pulse oximetry drops below 92% or the intubation time delayed beyond 90 s, whichever occurring earlier. Bag and mask ventilation will be resumed between the intubation attempts. Next attempt will be performed using any additional technique like bougie or external laryngeal pressure. A maximum of 2 attempts will be allowed. If intubation fails after two attempts, failure of intubation will be declared and standard intubation without cervical spine immobilisation by removing cervical collar or MILS will be performed. Number of attempts required and failure to intubate will be noted. Any airway-related complications such as airway trauma in the form of injury to lips, teeth, mucosal injury, laryngeal oedema, laryngospasm, bronchospasm will be noted. After confirming the successful intubation, patient will be handed over to surgeons and surgery will be proceeded.



 
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