| CTRI Number |
CTRI/2017/10/010231 [Registered on: 27/10/2017] Trial Registered Retrospectively |
| Last Modified On: |
06/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study of airway access in cervical spine injury by two different methods |
|
Scientific Title of Study
|
Comparative study of awake orotracheal intubation using fibreoptic scope versus video laryngoscope in patients undergoing surgery for unstable cervical spine |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Kaustuv Dutta |
| Designation |
Senior Resident Doctor |
| Affiliation |
NIMHANS |
| Address |
Department of Neuroanaesthesia,
NIMHANS
Bangalore
Hosur Road
Bangalore
Telephone: 91-080-26995201, 26995202
Bangalore
KARNATAKA
560029
India |
| Phone |
9535050421 |
| Fax |
|
| Email |
kaustuv.dutta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sriganesh |
| Designation |
Additional Professor |
| Affiliation |
NIMHANS |
| Address |
Department of Neuroanaesthesia
NIMHANS, Bangalore
Hosur Road
Bangalore - 560029, India
Bangalore
KARNATAKA
560029
India |
| Phone |
9480829727 |
| Fax |
|
| Email |
drsri23@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sriganesh |
| Designation |
Additional Professor |
| Affiliation |
NIMHANS |
| Address |
Department of Neuroanaesthesia
NIMHANS, Bangalore
Hosur Road
Bangalore - 560029, India
Bangalore
KARNATAKA
560029
India |
| Phone |
9480829727 |
| Fax |
|
| Email |
drsri23@rediffmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
none |
| Address |
none |
| 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 Kaustuv Dutta |
NIMHANS |
Department of neuroanaesthesia and neurocritical care
Bangalore
KARNATAKA |
9535050421
kaustuv.dutta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nimhans Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
, All patients between 18 and 65 years, belonging to ASA status I – III with upper cervical spine (C1 to C4) pathology and resultant instability, scheduled for elective surgery under GA, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
fibreoptic scope |
Awake orotracheal intubation will be done using fibreoptic scope or video laryngoscope in patients undergoing surgery for unstable cervical spine. It is a comparative study wherein the motion at the unstable cervical spine will be computed using X rays taken during intubation at three different time points. |
| Comparator Agent |
video laryngoscope |
Awake orotracheal intubation will be done using fibreoptic scope or video laryngoscope in patients undergoing surgery for unstable cervical spine. It is a comparative study wherein the motion at the unstable cervical spine will be computed using X rays taken during intubation at three different time points. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All patients aged between 18 and 65 years, belonging to ASA status I – III physical status with upper cervical spine (C1 to C4) pathology and resultant instability, scheduled for elective stabilization surgery, under general anaesthesia at National Institute of Mental Health and Neurosciences, Bengaluru. |
|
| ExclusionCriteria |
| Details |
Morbidly obese patients
Difficult airway- oropharyngeal pathology or mouth opening less than 3 cm
Patients who refuse to give consent
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary objective is to assess cervical-spine movement at C1/2 and C2/3 level during intubation.
|
T1- Timepoint 1 is baseline X ray with cervical spine in neutral position
T2- timepoint 2 is x ray taken during best laryngoscopy view using VL(McGrath) or with fibreoptic scope in trachea with Fibreoptic bronchoscope
T3- is Timepoint 3 when the tube is in trachea in both the groups |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary objectives are to assess change in the neurological status (motor power and sensory examination in both upper and lower limbs) during intubation process and evaluate hemodynamic changes, intubation success and patient satisfaction regarding awake intubation with these two techniques.
|
after intubation for neurological assessment
after surgery for patients satisfaction |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="46" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/10/2016 |
| Date of Study Completion (India) |
31/10/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="25" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
 Dutta K, Sriganesh K, Chakrabarti D, Pruthi N, Reddy M. Cervical Spine Movement During Awake Orotracheal Intubation With Fiberoptic Scope and McGrath Videolaryngoscope in Patients Undergoing Surgery for Cervical Spine Instability: A Randomized Control Trial. J Neurosurg Anesthesiol. 2020 Jul;32(3):249-255. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study aims to compare awake orotracheal intubation using two different techniques- Mc Grath videolaryngoscopy assisted and fibreoptic guided in patients with risk of secondary cervical cord injury due to unstable cervical spine coming for definitive surgery at NIMHANS, Bangalore, India during June 2016 to November 2017.The primary objective is to assess cervical-spine movement at C1/2 and C2/3 level during intubation. Secondary objectives are to assess change in the neurological status (motor power and sensory examination in both upper and lower limbs) during intubation process and evaluate hemodynamic changes, intubation success and patient satisfaction regarding awake intubation with these two techniques. |