| CTRI Number |
CTRI/2021/09/036745 [Registered on: 22/09/2021] Trial Registered Prospectively |
| Last Modified On: |
31/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [50] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
After any trauma to neck airway is difficult to secure this study observe two divices for this one is via vediography and other by direct under vision. |
|
Scientific Title of Study
|
Comparison of C-MAC D-Blade videolaryngoscope and McCoy Laryngoscope for nasotracheal intubation in cervical spinal surgery:A prospective randomized study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amit Kumar |
| Designation |
Junior Resident (accadmic) |
| Affiliation |
IGIMS, Patna |
| Address |
Indira Gandhi Institute of Medical Sciences. Patna
Patna
BIHAR
800014
India |
| Phone |
8210648881 |
| Fax |
|
| Email |
ak1459104@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swati |
| Designation |
Additional professor |
| Affiliation |
IGIMS, Patna |
| Address |
Indira Gandhi Institute of Medical Sciences. Patna
Patna
BIHAR
800014
India |
| Phone |
8544413241 |
| Fax |
|
| Email |
swatipgi2006@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amit Kumar |
| Designation |
Junior Resident (accadmic) |
| Affiliation |
IGIMS, Patna |
| Address |
Indira Gandhi Institute of Medical Sciences. Patna
Patna
BIHAR
800014
India |
| Phone |
8210648881 |
| Fax |
|
| Email |
ak1459104@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Indira Gandhi Institute of Medical Sciences Patna |
| Address |
Department of Anaesthesia and Critical care medicine 1st floor near neuro OT complex IGIMS Patna |
| 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 |
| Dr Amit Kumar |
First floor, near PAC clinic Neuro OT No. 7,8 |
Department of anaesthesia and critical care medicine IGIMS Patna.
Patna
BIHAR |
8210648881
ak1459104@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of ethic committee IGIMS, Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, (2) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
C MAC D Blade Videolaryngoscope |
For 2min |
| Comparator Agent |
McCoy Laryngoscope |
2min. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1 Patient undergoing cervical spine surgery
2 BMI between 20 to 30
3 ASA Grade 1to3 |
|
| ExclusionCriteria |
| Details |
1 Patient not giving consent.
2 Mallampati Score 4
3 Thyromeatel distance of less than 6cm
4 Recurrent epistaxis etc |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of duration of intubation;(noses to Oropharynx, Oropharynx into glottic inlet, and glottis inlet to trachea.) Between C Mac D blade videolaryngoscope and McCoy Laryngoscope. |
2min, 3min, 4min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) glottic opening as percentage of glottic opening (pogo) score
2) Cormack lehane grade
3) Hemodynamic changes before and after intubation.
4) complications related to videolaryngoscope.
5) vitals monitoring before and after intubation |
5,10,15,20minutes |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
10/10/2021 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Plan to publish after completion of study. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Purpose of this study is to decide better way to secure airway in cervical spine injury patients to prevent further damage to the spinal cord and prevent any neurological damage during intubation. |