| CTRI Number |
CTRI/2025/07/089959 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of perioperative Respiratory complications in children undergoing anaesthesia for ENT surgeries. |
|
Scientific Title of Study
|
Study of incidence of Perioperative respiratory Adverse Events(PRAE) in children aged 1 month to 12 years undergoing anaesthesia for surgeries involving ear, nose and throat and the risk factors associated with these Perioperative Respiratory Adverse Events, an observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Beaula P |
| Designation |
Post graduate |
| Affiliation |
Christian medical College, vellore |
| Address |
Post graduate, Department of Anaesthesiology, Christian Medical College, Vellore Tamil Nadu
Vellore
TAMIL NADU
632004
India |
| Phone |
7639668380 |
| Fax |
|
| Email |
beaulaskaria@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aparna Williams |
| Designation |
Professor |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Professor,Department of Anaesthesiology, Christian Medical College, Vellore Tamil Nadu
Vellore
TAMIL NADU
632004
India |
| Phone |
8098899339 |
| Fax |
|
| Email |
aparnaw@cmcvellore.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Beaula P |
| Designation |
Post graduate |
| Affiliation |
Christian medical College, vellore |
| Address |
Post graduate, Department of Anaesthesiology, Christian Medical College, Vellore Tamil Nadu
TAMIL NADU
632004
India |
| Phone |
7639668380 |
| Fax |
|
| Email |
beaulaskaria@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institutional Review Board(Ethics and Research Committe), Christian Medical College Vellore, Tamil Nadu, India PIN 632004 |
|
|
Primary Sponsor
|
| Name |
Institutional Review Board Ethics and Reseach Committe Christian Medical College Vellore |
| Address |
Institutional Review Board(Ethics and Reseach Committe),Office of Research, Christian Medical college,Vellore,Tamil Nadu, India PIN 632004 |
| 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 Beaula P |
Christian Medical College, Vellore, Tamil Nadu |
Department of anaestheia and Department of ENT- Operating rooms
Vellore
TAMIL NADU |
7639668380
beaulaskaria@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Review Board (Researcha nd Ethics Committee) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
All children in the age group of 1 month to 12 years undergoing anaesthesia for elective ENT surgeries during a period of 1 year |
|
| ExclusionCriteria |
| Details |
Age less than 1 month and more than 12 years
Parents denial and ASA physical status 4 and 5
Children with cyanotic heart disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Development of Peri operative Respiratory Adverse Events during elective ENT surgeries in children of aged 1 month to 12 years |
at baseline and after surgery (on same day) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the risk factors associated with PRAE & validating "Score for prediction of Post oeprative respiratory complications in infants & children - SPORC C" |
baseline & at the end of surgery on the same day |
|
|
Target Sample Size
|
Total Sample Size="255"
Sample Size from India="255"
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)
|
12/07/2025 |
| 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
|
The incidence of Perioperative Respiratory Adverse Events (PRAEs) in children undergoing anaesthesia for ENT surgeries with risk factors associated with PRAEs will be studied.Children aged 1 month to 12 years are included.Informed consent is obtained prior to the surgery.
PRAEs are one of the most common complications after anaesthesia especially is paediatric age group.There is no enoiugh data abouth the same in South Indian population.Hence I would like to study this.
On the day of surgery, patient is taken up for surgery and after giving required anaesthesia, surgery will be commenced.At the end of surgery, extubated and shifted to recovery room.In recovery room, patient will be observed for the development of respiratory adverse events and will be documented. |