| CTRI Number |
CTRI/2020/05/025185 [Registered on: 15/05/2020] Trial Registered Prospectively |
| Last Modified On: |
14/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Preoperative tests to predict difficult airway in children |
|
Scientific Title of Study
|
Comparative study of bedside tests to assess difficult airway in Paediatric patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abinandha kumar |
| Designation |
Post graduate in MD Anaesthesia |
| Affiliation |
Kasturba medical college,Mangalore |
| Address |
Department of anaesthesia Kasturba medical college,
203,lighthouse hill road,Hampanakatta,
managlore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9500375999 |
| Fax |
|
| Email |
abinandhkumar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suresh YV |
| Designation |
Professor |
| Affiliation |
Kasturba medical college,Mangalore |
| Address |
Department of anaesthesia Kasturba medical college,
203,lighthouse hill road,Hampanakatta,
managlore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9845085108 |
| Fax |
|
| Email |
sureshyv63@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abinandha kumar |
| Designation |
Post graduate in MD Anaesthesia |
| Affiliation |
Kasturba medical college,Mangalore |
| Address |
Department of anaesthesia Kasturba medical college,
203,lighthouse hill road,Hampanakatta,
managlore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9500375999 |
| Fax |
|
| Email |
abinandhkumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesia Kasturba medical college,
203,lighthouse hill road,Hampanakatta,
managlore |
|
|
Primary Sponsor
|
| Name |
kastuba medical college mangalore |
| Address |
203,Light house hill road Hampanakatta mangaluru karnataka |
| Type of Sponsor |
Private 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 Abinandha Kumar |
KMC,Hospitals |
department of anaesthesiology,
KMC Hospital,
Nandigudda road,
Attavar,Mangaluru
Dakshina Kannada
KARNATAKA |
9500375999
abinandhkumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Kasturba medical college , Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: V00-Y99||External causes of morbidity, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Patients of ASA 1 & 2 category
Patients posted for any elective procedure undergoing pre op
evaluation |
|
| ExclusionCriteria |
| Details |
Patients with craniofacial abnormalities
Patients undergoing emergency surgery
Patients of ASA >2
Patients who are un co-operative |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To anticipate difficult airway and to avoid intra operative hypoxia |
preoperative : difficult airway management can be planned
intra operative : complications such as hypoxia, bradycardia and cardiac arrest can be predicted |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To reduce mortality rate in paediatric patients |
Baseline : To reduce hypoxia related paediatric complications
Long term : To reduce infant mortality rate |
|
|
Target Sample Size
|
Total Sample Size="330"
Sample Size from India="330"
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)
|
15/05/2020 |
| 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="7"
Days="5" |
|
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)?
|
|
Brief Summary
|
To compare the various bedside tests to asses difficult airway in paediatric patients
This study will also help in avoiding complications in paediatric age group
It will also reduce mortality rate in paediatric patients |