| CTRI Number |
CTRI/2017/10/010242 [Registered on: 30/10/2017] Trial Registered Retrospectively |
| Last Modified On: |
25/10/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between two types of laryngoscopes used during insertion of breathing tube into the trachea during General Anaesthesia in neck surgeries. |
|
Scientific Title of Study
|
Comparison between macintosh laryngoscope and king vision Video laryngoscope, for intubation in cervical Spine injured patients, with manual-in-line-axial stabalization |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohit Kumar |
| Designation |
DNB - Anaesthesia |
| Affiliation |
Indian Spinal Injuries Centre |
| Address |
Department of Anaesthesia, Indian Spinal Injuries Centre,
Sector C, Vasant Kunj,
New Delhi
South
DELHI
110070
India |
| Phone |
|
| Fax |
|
| Email |
drmohitsaini87@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Abhinav Gupta |
| Designation |
Assistant Consultant - Anaesthesia |
| Affiliation |
Indian Spinal Injuries Centre |
| Address |
Department of Anaesthesia, Indian Spinal Injuries Centre,
Sector C, Vasant Kunj,
New Delhi
South
DELHI
110070
India |
| Phone |
9990419377 |
| Fax |
|
| Email |
little.3001@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Abhinav Gupta |
| Designation |
Assistant Consultant - Anaesthesia |
| Affiliation |
Indian Spinal Injuries Centre |
| Address |
Department of Anaesthesia, Indian Spinal Injuries Centre,
Sector C, Vasant Kunj,
New Delhi
South
DELHI
110070
India |
| Phone |
9990419377 |
| Fax |
|
| Email |
little.3001@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Indian Spinal Injuries Centre |
| Address |
Sector C, Vasant Kunj
New Delhi
110079 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Mohit Kumar |
Indian Spinal Injuries Centre |
Department of Anaesthesia, I floor (Inside Operation Theatre)
South
DELHI |
9634428683
drmohitsaini87@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee, Indian Spinal Injuries Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients of cervical spine injury, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
KingVision Videolaryngoscope |
It is a videolaryngoscope, with a channel to carry the Endotracheal tube. It has a specific J shape which theoritically makes it easy to angulate the ETT inside the mouth, with less motion of the neck |
| Comparator Agent |
Macintosh Laryngoscope |
It is the conventional and most commonly used laryngoscope for direct laryngoscopy, used during General Anaesthesia and during emergencies. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of cervical spine injury
2.ASA grade 1 to 3
3.Posted in the Operation Theatre for cervical spine fixation.
|
|
| ExclusionCriteria |
| Details |
1.Difficult airway due to reduced mouth opening <5cm
2.Anatomical abnormalities such as congenital anomalies
3.Trauma to airway, broken teeth, blood in airway making direct laryngoscopy difficult
4.Patients who required Rapid sequence intubation
5.Those who were on ionotropic or vasopressor support.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Intubation Difficultly Scale Score |
Easy less than 1
Moderate 1 to 5
Difficult more than 5 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of Intubation |
Seconds |
| Mean Arterial Pressure |
Before intubation
At 1min 2 min 3 min 4 min and 5 min |
| Heart Rate |
Before intubation
At 1 2 3 4 5 minutes after intubation |
| Complications |
Tooth injury
Tongue injury
Pharyngeal injury |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2015 |
| Date of Study Completion (India) |
30/09/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
No publication till date |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Primary Purpose
Intubation procedure in any patient, with Conventional Macintosh Laryngoscope, requires movement of neck and alignment of oro-pharyngo-laryngeal axis in straight line. This manuever in some cases of cervical injury, may lead to deterioration of neurological status of patient. Or on the other hand, if neck is immobilised, intubation becomes difficult, which may lead to life threatening complications.
So, the purpose of conducting this study was to evaluate the ease, safety and efficacy of KingVision Video laryngoscope in intubating cervical injury patients with neck immobilisation vis a vis the conventional Macintosh Laryngoscope (which is the most common, and versatile laryngoscope in use till date)
Hypothesis
We hyothesise that intubation with KingVision Videolaryngoscope because of its specific shape and a channel to carry the tube, will be easier and safer than the conventional Macintosh Laryngoscope, in cases of cervical injury patients, with neck immobilisation with MILS technique. |