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
|
|
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
|
|
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 |