| CTRI Number |
CTRI/2026/02/102966 [Registered on: 04/02/2026] Trial Registered Prospectively |
| Last Modified On: |
03/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study in Surgical Patients to Assess the Risk of Lung Complications After Anesthesia Using a Mobile Application |
|
Scientific Title of Study
|
Empowering Anesthesiologists A Mobile App to Individualize Risk Assessment and Compare Anesthetic Techniques for Predicting Postoperative Pulmonary Complications Highlights decision support and patient care |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ajay Pujala |
| Designation |
Post Graduate Resident |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Department of Anaesthesiology
Saveetha Medical College and Hospital
Saveetha Nagar, Thandalam
Chennai, Kancheepuram District
Tamil Nadu – 602105
India
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9182633194 |
| Fax |
|
| Email |
pujala.ajay304@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Guna Sekharan |
| Designation |
Professor |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Department of Anaesthesiology
Saveetha Medical College and Hospital
Saveetha Nagar, Thandalam
Chennai, Kancheepuram District
Tamil Nadu – 602105
India
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9566137571 |
| Fax |
|
| Email |
guna.kali@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Guna Sekharan |
| Designation |
Professor |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Department of Anaesthesiology
Saveetha Medical College and Hospital
Saveetha Nagar, Thandalam
Chennai, Kancheepuram District
Tamil Nadu – 602105
India
TAMIL NADU
602105
India |
| Phone |
9566137571 |
| Fax |
|
| Email |
guna.kali@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Medical College and Hospital
Saveetha Nagar, Thandalam
Chennai, Kancheepuram District
Tamil Nadu – 602105
India |
|
|
Primary Sponsor
|
| Name |
Saveetha Medical College and Hospital |
| Address |
Department of Anaesthesiology
Saveetha Medical College and Hospital
Saveetha Nagar, Thandalam
Chennai, Kancheepuram District
Tamil Nadu – 602105
India |
| 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 Ajay Pujala |
Saveetha Medical College and Hospital |
Department of Anaesthesiology
Saveetha Medical College and Hospital
Saveetha Nagar, Thandalam
Chennai, Kancheepuram District
Tamil Nadu – 602105
India
Kancheepuram
TAMIL NADU |
9182633194
pujala.ajay304@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Medical College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J958||Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients aged greater than 18 years
Patients undergoing elective surgery under general or regional anesthesia
ASA physical status one two three
Patients providing written informed consent |
|
| ExclusionCriteria |
| Details |
Emergency surgeries
Patients with pre-existing severe pulmonary disease requiring ventilatory support
Patients unwilling to participate
ASA physical status IV and V |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of postoperative pulmonary complications within the postoperative period, including atelectasis, pneumonia, respiratory failure, and need for postoperative ventilatory support. |
Baseline (preoperative), intraoperative period, and postoperative period (up to 7 days after surgery or until hospital discharge, whichever is earlier). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Accuracy of mobile app–based risk prediction
Association between anesthetic technique & pulmonary complications
Utility of the app in perioperative decision-making
Length of hospital stay & ICU admission related to pulmonary complications |
Baseline (preoperative), intraoperative, & early postoperative period (up to 7 days or discharge). |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
16/02/2026 |
| 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="0"
Months="0"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This prospective observational study aims to evaluate a mobile application designed to assist anesthesiologists in individualized perioperative risk assessment and comparison of anesthetic techniques for predicting postoperative pulmonary complications The application integrates patient specific clinical parameters to generate risk predictions without influencing routine anesthetic management The study focuses on enhancing perioperative decision support improving patient safety and optimizing anesthetic planning through digital health innovation |