| CTRI Number |
CTRI/2025/03/082050 [Registered on: 10/03/2025] Trial Registered Prospectively |
| Last Modified On: |
10/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Planning a study to see if there is a link between how severe eosinophilia is and the risk of airway problems during surgery in kids. |
|
Scientific Title of Study
|
A perioperative observational study to determine the association between severity of eosinophilia with perioperative airway complications in paediatric patients at tertiary care hospital. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sona Elizabeth Jose |
| Designation |
JR Anaesthesia Department |
| Affiliation |
Bharati vidyapeeth (DEEMED to be UNIVERSITY) medical college Pune - Satara road, Pune |
| Address |
Anaesthesia Department
Room No. 3
Bharati vidyapeeth (DEEMED to be UNIVERSITY) medical college Pune - Satara road, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
7012688697 |
| Fax |
|
| Email |
Sonaelza554@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarita Swami |
| Designation |
Professor in department anaesthesiology |
| Affiliation |
Bharati vidyapeeth medical college pune |
| Address |
Anaesthesia Department
Room No. 3
Bharati Vidyapeeth medical college Pune Satara road pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9822846369 |
| Fax |
|
| Email |
drswamisarita@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sarita Swami |
| Designation |
Professor in department anaesthesiology |
| Affiliation |
Bharati vidyapeeth medical college pune |
| Address |
Anaesthesia Department
Room No.3
Bharati Vidyapeeth medical college Pune Satara road pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9822846369 |
| Fax |
|
| Email |
drswamisarita@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Bharati vidyapeeth (DEEMED to be UNIVERSITY) medical college Pune - Satara road, Pune 411043 |
|
|
Primary Sponsor
|
| Name |
Dr Sona Elizabeth Jose |
| Address |
Bharati Vidyapeeth (DEEMED to be) medical college Pune -Satara, Dhankawadi, Pune 411043 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Sona Elizabeth Jose |
Bharati Vidyapeeth hospital |
Room No. 3
Anaesthesia Department
Bharati vidyapeeth medical college Katraj Dhankawadi Pune
Pune
MAHARASHTRA |
7012688697
Sonaelza554@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
1.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age 1 to 18
ASA I/II patients
Patients undergoing elective surgeries |
|
| ExclusionCriteria |
| Details |
Patients with associated comorbid conditions
A difficult airway requiring more than three intubation attempts
Airway surgeries |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the association between severity of eosinophilia with perioperative airway complications. |
intubation ,5mins, 15mins, 30mins, 2hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the association between severity of eosinophilia with perioperative airway complications |
Post extubation of general anaesthesia, comparison of severity of eosinophilia with airway complications |
|
|
Target Sample Size
|
Total Sample Size="471"
Sample Size from India="471"
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)
|
21/03/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is a prospective, observational study to determine the association between severity of eosinophilia with perioperative airway complications in pediatric patient at tertiary care hospital
Parameters will be assessed intra operative from time of intubation upto postoperative 2hours. A comparison between mild, moderate and severe eosinophil count and its association with respiratory airway complications will be noted. |