| CTRI Number |
CTRI/2025/07/090293 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
11/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Breathing problems during and after surgery in children aged 1 month to 12 years. A study to find out how often they happen and what increases the risk |
|
Scientific Title of Study
|
Incidence and risk factors of perioperative respiratory adverse events in paediatric population of 1 month to 12 years age group undergoing elective surgeries in a tertiary care hospital 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 |
Vejans vishal antony v |
| Designation |
Junior resident |
| Affiliation |
Christian medical college |
| Address |
Department of anaesthesia cmc vellore
Vellore TAMIL NADU 632004 India |
| Phone |
9894393655 |
| Fax |
|
| Email |
vejansonantony08@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Meghna jiwanmall |
| Designation |
Professor |
| Affiliation |
Christian medical college |
| Address |
Department of anaesthesia cmc vellore
Vellore TAMIL NADU 632004 India |
| Phone |
9626697368 |
| Fax |
|
| Email |
meghna@cmcvellore.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Meghna jiwanmall |
| Designation |
Professor |
| Affiliation |
Christian medical college |
| Address |
Department of anaesthesia cmc vellore
Vellore TAMIL NADU 632004 India |
| Phone |
9626697368 |
| Fax |
|
| Email |
meghna@cmcvellore.ac.in |
|
|
Source of Monetary or Material Support
|
| Fluid grant christian medical college vellore |
|
|
Primary Sponsor
|
| Name |
Fluid grant christian medical college vellore |
| Address |
Department of anaesthesia cmc vellore |
| 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 |
| Vejans vishal antony v |
christian medical collage vellore |
ida scudder road, thottapalyam, vellore, pin-632004 Vellore TAMIL NADU |
9894393655
vejansonantony08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituition Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K380||Hyperplasia of appendix, (2) ICD-10 Condition: N478||Other disorders of prepuce, (3) ICD-10 Condition: K560||Paralytic ileus, (4) ICD-10 Condition: N471||Phimosis, (5) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, |
|
|
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 |
Children of 1month-12 years age group posted for elective general surgery |
|
| ExclusionCriteria |
| Details |
Parents refusal
age less than 1 month or more than 12years
emergency surgeries
patients with tracheostomy in situ
Patients on mechanical ventilation
airway related ent surgery
asa status more than 3 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the incidence of perioperative respiratory adverse events in paediatric population of 1month to 12 years age group, undergoing elective general surgeries till their discharge from the hospital. |
From induction to discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Study the risk factors associated with developing PRAEs in paediatric population during intraoperative postoperative period |
From induction to discharge |
| To assess Score for Prediction of Postoperative Respiratory Complications in Infants and Children SPORC C scoring as a screening tool for risk prediction of perioperative respiratory adverse events in this paediatric population. |
From induction to discharge |
|
|
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)
|
15/07/2025 |
| 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
Modification(s)
|
PRAEs are common and serious complications in paediatric anaesthesia, significantly increasing hospital stays, healthcare costs, and risks of morbidity and mortality. These events include bronchospasm, laryngospasm, apnea, airway obstruction, desaturation, prolonged oxygen requirements,pneumonitis pulmonary edema and prolonged mechanical ventilation requiring ICU admission. The proposed research aims to study the incidence and risk factors of PRAEs in our paediatric population of infants to 12 years age group undergoing elective surgeries at our paediatric surgery operation theatres. Young children have high oxygen demands and low oxygen reserves, making them more susceptible to hypoxemia. As per the literature search, the risk factors include younger age, higher ASA physical status, and presence of conditions like chronic lung disease or neuromuscular disorders, airway surgeries, prolonged anesthesia, high FiO2, and intraoperative hemodynamic instability. Our study focuses on seeing the incidence and other associated risk factors amongst the surgeries done in this cohort of paediatric surgery patients in our Indian population. Additionally, we will be calculating the risk prediction score using SPORC C, which is a recently developed & validated scoring system. This 11 predictors scoring system may help us in classifying children into high & low risk groups. Prediction of PRAEs in our study will be very helpful in anticipating perioperative complications and thereby help in preparing adequately to prevent and treat adverse events successfully, ensuring safe patient care. Analyzing the findings may help us develop our preanaesthetic assessment of patients and highlight the gaps thereby improving targeted training program. It can help us incorporate the scoring system in our assessment protocol in future that may be beneficial in formulating a treatment plan for patients in high-risk group. We hope that our results will help with preoperative optimization, careful airway management, and individualized ventilation strategies to mitigate PRAEs, improving outcomes and cost effectiveness associated with paediatric anaesthesia. |