| 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 |
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Public Title of Study
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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 |
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Scientific Title of Study
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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 |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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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 |
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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 |
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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 |
|
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Source of Monetary or Material Support
|
| All India Institute of Medical Science,Sri Aurobindo Marg, Ansari Nagar East, New Delhi, 110029 |
|
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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 |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
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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 |
|
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Regulatory Clearance Status from DCGI
|
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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, |
|
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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. |
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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.
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| ExclusionCriteria |
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of Intubation Difficulty Scale (IDS) score between two groups |
At the time of intubation |
|
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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 |
|
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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" |
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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" |
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Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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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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