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CTRI Number  CTRI/2024/04/065456 [Registered on: 09/04/2024] Trial Registered Prospectively
Last Modified On: 06/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study the difference between fibre optic bronchoscope intubation and C Mac video laryngoscopic intubation in cervical spine injury patient under awake condition 
Scientific Title of Study   Comparison between C-MAC video laryngoscope versus fibreoptic bronchoscope for awake intubation under ketofol-ketamine plus propofol sedation in cervical spine injury: immobilised with cervical collar: Prospective Randomized 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 Thalishetti Yugala  
Designation  Junior resident (M.D.) 
Affiliation  Nizams Institute of medical sciences  
Address  Department of Anaesthesiology and intensive care, Nizams institute of medical sciences, punjagutta Hyderabad, Telangana, India

Hyderabad
TELANGANA
500082
India 
Phone  8106172890  
Fax    
Email  yugalayugi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sapna annaji nikhar 
Designation  Associate professor  
Affiliation  Nizams institute of medical sciences  
Address  Department of Anaesthesiology and intensive care, Nizams institute of medical sciences, punjagutta Hyderabad, Telangana, India

Hyderabad
TELANGANA
500082
India 
Phone  9030460262  
Fax    
Email  sapnanikhar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Thalishetti Yugala  
Designation  Junior resident (M.D.) 
Affiliation  Nizams institute of medical sciences  
Address  Department of Anaesthesiology and intensive care, Nizams institute of medical sciences, punjagutta Hyderabad, Telangana, India

Hyderabad
TELANGANA
500082
India 
Phone  8106172890  
Fax    
Email  yugalayugi@gmail.com  
 
Source of Monetary or Material Support  
Nizams institute of medical sciences, panjagutta, Hyderabad, Telangana, 500082 
 
Primary Sponsor  
Name  Dr. Thalishetti Yugala  
Address  Junior resident (M.D.), Department of anaesthesiology and intensive care,Nizams institute of medical sciences, punjagutta, Hyderabad, 500082, Telangana. Ph no. 8106172890, yugalayugi@gmail.com 
Type of Sponsor  Other [Self] 
 
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 
DrThalishetti Yugala  Nizams institute of medical sciences   Department of anaesthesiology and intensive care, Nizams institute of medical sciences, panjagutta, Hyderabad, Telangana, 500082
Hyderabad
TELANGANA 
8106172890

yugalayugi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Nims institutional ethics committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S129||Fracture of neck, unspecified, (2) ICD-10 Condition: S130||Traumatic rupture of cervical intervertebral disc, (3) ICD-10 Condition: S131||Subluxation and dislocation of cervical vertebrae, (4) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intubation using C-MAC video laryngoscope   C-MAC videolaryngoscope will be passed into the patients mouth over tongue in midline, distal end of C-MAC laryngoscope is positioned in vallecula with the glottis in the centre the applicator will advance the laryngoscope by adjusting the distal portion until its tip will be placed immediately superior to glottis and bilateral pyriform recess. After the bougie is successfully advanced through the glottis, endotracheal tube would be rail roaded over the bougie. This will be considered as success of intubation after confirmation with capnography.  
Comparator Agent  Intubation using fibre optic bronchoscope  FOB is passed 6–8 cm in the mouth, past the palate and then the uvula and the lever is used to look up, for the first landmark—the epiglottis, once the epiglottis is identified advance FOB towards laryngeal opening and then into the sub glottic space, after visualisation of glottis- Spray of lignocaine as you go and advances more until trachea and carina appears, now slide the endotracheal tube, inflate the cuff and tube will be connected to ventilator to confirm using capnography  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. ASA 1 and 2 patients
2. Patients above 18 years and less than 70 years
3. Patients with BMI less than 30
4. Patients undergoing elective surgeries
5. Patients with traumatic cervical spine injury with neck collar 
 
ExclusionCriteria 
Details  1. Patient who do not consent for study
2. Patients at risk of aspiration
3. Emergency surgeries
4. Patients with high risk for surgery like cardiac condition
5. Patients with local anaesthetic allergy
6. Patients with delirious symptoms, cognitive dysfunction
7. Patients with other cervical spine diseases 
 
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 
To compare the success of intubation in first attempt with C-MAC video laryngoscope versus fibreoptic bronchoscope for awake intubation under ketofol sedation in cervical spine injury: immobilised with cervical collar  Time for successful intubation(T1+T2) T1- time for visualisation of glottis
T2- from visualisation of glottis to confirmation of intubation by capnography  
 
Secondary Outcome  
Outcome  TimePoints 
Haemodynamic changes   Heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, saturation at baseline, 5 minutes, 10 minutes before intubation, 0 minutes, 5 minutes, 10 minutes, 15 minutes after intubation  
Ease of intubation by Likert scale  1- extremely easy
2- easy
3- somewhat easy
4- not very easy
5- most difficult  
Ramsay sedation score  1- anxious and agitated or restless or both
2- cooperative, oriented and tranquil
3- responding to commands only
4- brisk response to loght glabellar tap or loud auditory stimulus
5- sluggish response to light glabellar tap or loud auditory stimulus
6- no response to stimulus  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 2 
Date of First Enrollment (India)   18/04/2024 
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="0"
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   In patients with cervical spine injury, airway management poses a bigger challenge due to risk of neurological damage related to neck movements thus manual in line stabilization or cervical collar is commonly applied to minimise neck movements, such immobilisation can render intubation under direct laryngoscopy more difficult.
Securing the airway without cervical spine movement to avoid any neurological catastrophe is always an anaesthetic challenge. These issues have prompted the development of number of alternatives to Macintosh laryngoscope such as C-MAC, fibre optic, McCoy laryngoscope, intubating laryngeal mask airway, C-Trach and Bullard laryngoscope. 
Awake fibre optic bronchoscope intubation is gold standard in cervical spine injury, but its time consuming and requires more psychomotor skills and training. The C-MAC  is a nonchannelled video laryngoscope. The primary feature of D blade is its shape, which is an elliptically tapered blade raising to the distal. It claims to provide an easy option in difficult laryngoscopies. Studies have done proving that it is less time consuming and intubation time can be shorter and no separate skills needed for using C-MAC as technique is same as laryngoscope technique and gives ease of intubation. There are no studies comparing C-MAC with fibre optic intubation in traumatic cervical spine immobilised with cervical collar.
We planned this study to compare C-MAC intubation with gold standard fibre optic intubation in traumatic cervical spine. Awake intubation has added advantage in assessing neurological status post intubation and we can have control on airway. In an awake, unprepared patient with excessive salivation, gag and cough reflex can make intubation more challenging. These can be reduced by addition of antisialogogues, and  topicalization of airway with nebulisation with 10% lignocaine and achieving sedation with ketofol because of its profound analgesia and amnesia while maintaining protective airway reflexes, spontaneous respiration along with stabilizing hemodynamic profile and quick recovery. Hence, this study aims to compare the efficacy of  success of intubation in first attempt with C-MAC video laryngoscope versus fibre optic bronchoscope for awake intubation under ketofol (ketamine plus propofol) sedation in cervical spine injury: immobilised with cervical collar.

 
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