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CTRI Number  CTRI/2025/02/081380 [Registered on: 27/02/2025] Trial Registered Prospectively
Last Modified On: 22/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   A prospective study that examines the external validity of a risk prediction model for postoperative pulmonary problems based on lung ultrasonography data in patients undergoing abdominal operations  
Scientific Title of Study   External validation of Lung USG based Post operative pulmonary complications risk prediction model A prospective 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  Varsha Yadav 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Department of Anaesthesiology,Pain Medicine and Critical care ,5th Floor,Academic Block ,AIIMS,New Delhi Ansari nagar

South
DELHI
110029
India 
Phone  8076413052  
Fax    
Email  varshayadav1297@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sulagna Bhattacharjee 
Designation  Associate Professor 
Affiliation  Aiims,New Delhi 
Address  Department of Anaesthesiology,Pain Medicine and Critical care ,room no 14,4th Floor, Porta cabinAcademic Block ,AIIMS,New Delhi Ansari nagar

South
DELHI
110029
India 
Phone  9818212531  
Fax    
Email  bhattacharjee.sulagna85@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Varsha Yadav 
Designation  Junior Resident 
Affiliation  Aiims,New Delhi 
Address  Department of Anaesthesiology,Pain Medicine and Critical care ,5th Floor,Academic Block ,AIIMS,New Delhi Ansari nagar

South
DELHI
110029
India 
Phone  8076413052  
Fax    
Email  varshayadav1297@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  All India Institute Of Medical Sciences 
Address  Ansari nagar ,New Delhi 110029 
Type of Sponsor  Government medical college 
 
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 
Dr Varsha yadav  AIIMS,New Delhi  Department of anaesthesia ,Paine medicine and Critical care ,OT COMPLEX
South
DELHI 
8076413052

varshayadav1297@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K00-K95||Diseases of the digestive system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  undergoing major abdominal surgery of duration more than two hours either elective or emergency 
 
ExclusionCriteria 
Details  Refusal to participate.
Pregnancy or Postpartum up to 6 weeks
Preoperative requirement of mechanical ventilation.
Preoperative room air oximetry SaO2 less than 90%, or PaO2 less than 60 mmHg.
Patients requiring high doses of vasopressor support (Norepinephrine equivalent more than 0.2 mcg/ kg /min).
ASA 5 patients, not expected to live beyond 24 hours


 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
External validation of a logistic regression model comprised of clinical and lung USG parameters in adult patients undergoing elective or emergency surgery  lung usg will be done in preoperative period ,before giving anaesthesia and postoperative period ,within 24hr 
 
Secondary Outcome  
Outcome  TimePoints 
1. Comparison of predictive accuracy in different subgroup of patients (elective versus emergency surgery, elderly (age more than 65y) versus younger adults (age below 65y).   Preoperative 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/03/2025 
Date of Study Completion (India) 06/07/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

Postoperative pulmonary complications (PPCs) are significant sources of morbidity and mortality in surgical patients, contributing to prolonged hospital stays, increased healthcare costs, and decreased quality of life. Accurate prediction and early identification of patients at high risk for developing PPCs are crucial for implementing preventive measures, optimizing perioperative management, and improving patient outcomes [1].

External validation, the process of evaluating model performance on independent datasets from different populations or healthcare settings, is essential for assessing the robustness and reliability of predictive models. It provides valuable insights into model generalizability, potential biases, and limitations, thereby informing clinical decision-making and guiding the implementation of predictive tools into routine practice.

Through comprehensive external validation, this research endeavours to address critical gaps in the current literature, contribute to the evidence base supporting predictive modelling in perioperative care, and ultimately, improve patient outcomes by facilitating early identification and targeted interventions for individuals at high risk of developing postoperative pulmonary complications. The logistic regression model was developed from a departmental project (CTRI/2023/09/058028) and it consists of baseline lung ultrasound aeration score, total leucocyte count, INR, serum albumin and serum creatinine. 

 

Primary Objective

External validation of a logistic regression model comprised of clinical and lung USG parameters in adult patients undergoing elective or emergency surgery

 
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