FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 

 
Close