| CTRI Number |
CTRI/2021/09/036642 [Registered on: 20/09/2021] Trial Registered Prospectively |
| Last Modified On: |
18/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of 2 laryngoscope for intubation.
|
|
Scientific Title of Study
|
Comparison of King Vision video laryngoscope and McCoy laryngoscope for routine airway management. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Parulbahen Savaliya |
| Designation |
Resident in MD anaesthesiology |
| Affiliation |
Government medical collage New civil hospital |
| Address |
A-17 professor quarter
Majura gate
Civil hospital surat
Department of anaesthesiology
Government medical college
New civil hospital
Majura gate
Surat-395001
Surat
GUJARAT
395001
India |
| Phone |
6353123606 |
| Fax |
|
| Email |
savaliyaparul898@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bansari N Kantharia |
| Designation |
Additional professor in MD anaesthesiology |
| Affiliation |
Government medical college, Surat, Gujarat |
| Address |
Department of anaesthesiology,government medical college Majura gate Surat,Gujarat
Surat
GUJARAT
395001
India |
| Phone |
9825690177 |
| Fax |
|
| Email |
bansarikantharia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bansari N Kantharia |
| Designation |
Additional professor in MD anaesthesiology |
| Affiliation |
Government medical college, Surat, Gujarat |
| Address |
Department of anaesthesiology,government medical college Majura gate Surat,Gujarat
Surat
GUJARAT
395001
India |
| Phone |
9825690177 |
| Fax |
|
| Email |
bansarikantharia@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology, Government medical college, majura gate surat,395001 |
|
|
Primary Sponsor
|
| Name |
Government medical college new civil hospital surat |
| Address |
New civil hospital Majura gate surat |
| 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 parul |
Government medical college and new civil hospital surat |
Department of anaesthesiology,
Government medical college and new civil hospital
Surat
Surat
GUJARAT |
6353123606
savaliyaparul898@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Research Ethics committee government medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
a)Patients posted for planned surgery in general anesthesia
b)Patients belonging to ASA grade 1,2or3
c)Patients in between the age group of 18-60 years
d)Patients who are giving written informed consent |
|
| ExclusionCriteria |
| Details |
a)History of difficult intubation or anticipated airway difficulties
b)Any pathology of oral cavity that may obstruct the insertion of device
c)Mouth opening <2.5 cm
d)Potentially full stomach patients (trauma, morbid obesity, pregnancy, H/o gastric regurgitation
e)Severe Cardio-respiratory or hepato-renal dysfunction |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
a.Ease of intubation with reference to:
•Total time of intubation
•Intubation Difficulty scale |
Maximum 24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a)Haemodynamics parameters
b)Cormack-Lehane score |
Minimum 24 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
23/09/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
23/09/2021 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
As per our departmental protocol standard anaesthesia technique will be intubated with either Macintosh Laryngoscope, Mc Coy laryngoscope, Millers laryngoscope ,Airtrac video laryngoscope ,King vision Video laryngoscope,Mac Grath video laryngoscope out of these I will observe those patients who will be intubated using either Mc coy laryngoscope or King vision video laryngoscope for 24 hours. |