| 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
|
|
|
Primary Sponsor
|
| Name |
All India Institute Of Medical Sciences |
| Address |
Ansari nagar ,New Delhi 110029 |
| Type of Sponsor |
Government medical college |
|
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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 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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
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Intervention / Comparator Agent
|
|
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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
|
|
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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
|
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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 |