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CTRI Number  CTRI/2015/06/005936 [Registered on: 22/06/2015] Trial Registered Prospectively
Last Modified On: 19/06/2015
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Intubation in patients with Neck injury patients 
Scientific Title of Study   : Comparison of tracheal intubation using King Vision and C-MAC videolaryngoscopes in patients with cervical spine immobilization 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dhanyasi Shravanalaxmi 
Designation  junior resident 
Affiliation  JIPMER, Pondicherry 
Address  second floor, institute block, JIPMER, PONDICHERRY
sathya nagar, saram
Pondicherry
PONDICHERRY
605006
India 
Phone  9789283166  
Fax    
Email  prasanna_bidkar@rediffmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prasanna Bidkar 
Designation  Associate professor 
Affiliation  JIPMER, Pondicherry 
Address  department of Anaesthesiology, second floor, jipmer

Pondicherry
PONDICHERRY
605006
India 
Phone  9442706168  
Fax    
Email  drprasannabidkar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Prasanna Bidkar 
Designation  Associate Professor 
Affiliation  JIPMER, Pondicherry 
Address  Department of Anaesthesiology, Second floor, Jawaharlal institute of postgraduate medical education and research (JIPMER),Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9442706168  
Fax    
Email  drprasannabidkar@gmail.com  
 
Source of Monetary or Material Support  
Postgraduate research monitoring committee. Jawaharlal postgraduate institute of postgraduate medical education and research (JIPMER Hospital) intramural grant, 2nd floor, institute block, dhanvantri nagar, Pondicherry 
 
Primary Sponsor  
Name  Jawaharlal postgraduate medical education and research PG research committee 
Address  first floor, institute block, JIPMER campus,dhanvantri nagar, Pondicherry 
Type of Sponsor  Government medical college 
 
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 
Dhanyasi Shravanalaxmi  Jawaharlal institute of postgraduate medical education and research (JIPMER)  Second floor, ROOM NO 61 institute block operation theatre,Department of Anaesthesiology, second flooor JIPMER Hospital, Dhanvantari nagar, Pondicherry
Pondicherry
PONDICHERRY 
9789283166

prasanna_bidkar@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Spinal cord injury,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  D blade of C-MAC videolaryngoscope  endotracheal intubation will be done using D blade of C-MAC videolaryngoscope 
Comparator Agent  King vision videolaryngoscope  King vision videolaryngoscope will be used for endotracheal intubation 
Intervention  Use of C-MAC videolaryngoscope  C-MAC videolaryngoscope will be used for securing endotracheal intubation after induction of anesthesia. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Inclusion criteria includes adults posted for elective surgeries requiring general anesthesia with intubation, with proven/suspected cervical spinal cord injury on cervical immobilization with rigid collar 
 
ExclusionCriteria 
Details  Exclusion criteria includes anticipated difficult airways with any other disorders and aspiration risk, other than cervical spine injury 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
First attempt intubation success, Intubation Difficulty Score and POGO score  First attempt intubation success in percentage, Intubation Difficulty Score based on 10 point score and POGO score based on percentage of glottic opening will be recorded during endotracheal intubation 
 
Secondary Outcome  
Outcome  TimePoints 
Time for intubation,any maneuvers required  Time in seconds that is time from insertion of Videolaryngoscope to the visualization of passing of the endotracheal tube through the glottis opening 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
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)   01/07/2015 
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="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

 

A.    Study procedure: After approval of JIPMER scientific advisory committee, Institute Ethics committee, registration from CTRI. Informed written consent from patient or relatives will be taken. A total of 180 patients meeting inclusion criteria will be enrolled in the study and randomized into one of the 3 groups K, C, D. Regular Pre-medications will be given with tablet famotidine 20 mg, diazepam 5mg in the night the day before surgery and tablet famotidine 20mg, Perinorm 10mg, diazepam 5mg in the morning of the day of surgery. After securing IV line, connecting standard monitors, pre-oxygenation will be done. Standard intubation protocol will be followed by using fentanyl 2 ug/kg, propofol 2mg/kg, vecuronium 0.1mg/kg. Cervical spine immobilization will be maintained by using a rigid cervical collar or manual in line stabilization and tracheal intubation will be performed by one of these 3 video laryngoscopes following manufacturers’ recommendations. Standard endotracheal tube of size 8 for the male and size 7 for the female will be used for all the patients in the study.

 

B.   Data collection methods including settings and periodicity:

a)     First attempt success rate

b)     More than 2 attempts – failure of the intubation

c)     Time for intubation – from scope passing teeth to tube seen passing vocal cords                                                                                                                                         Grading of intubation difficulty – modified IDS score8,9

d)     Percentage of glottic opening (POGO) score10

e)     Cormack - Lehane grading of glottic view

f)      Alternative techniques used like Bougie, External laryngeal manipulation, or Specialist needed.

g)     Ease of insertion

h)     Complications – airway trauma, esophageal intubation

 
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