| 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 |
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Public Title of Study
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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 |
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Scientific Title of Study
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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 |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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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 |
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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 |
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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 |
|
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Source of Monetary or Material Support
|
| Nizams institute of medical sciences, panjagutta, Hyderabad, Telangana, 500082 |
|
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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] |
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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 |
| 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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nims institutional ethics committee |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| 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, |
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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 |
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Inclusion Criteria
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| 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 |
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
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Participant and Outcome Assessor Blinded |
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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 |
|
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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 |
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Target Sample Size
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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" |
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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 |
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Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
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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