| CTRI Number |
CTRI/2026/03/105520 [Registered on: 06/03/2026] Trial Registered Prospectively |
| Last Modified On: |
05/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A digital alert system to quickly inform doctors about critical lab reports in patients with lung diseases. |
|
Scientific Title of Study
|
Development and Evaluation of an Alerting System for Critical Biochemical, Microbiological, and Cytological Values in Respiratory Medicine Patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
JESVANTHAN E |
| Designation |
Post graduate |
| Affiliation |
Saveetha medical college and hospital |
| Address |
Department of Respiratory medicine, Saveetha medical college and hospital, Saveetha institute of medical and technical sciences, Saveetha nagar, Thandalam, Chennai, India
Chennai TAMIL NADU 602105 India |
| Phone |
9442042428 |
| Fax |
|
| Email |
jesvanthanelango@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
ANBU MARAN PM |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Saveetha medical college and hospital |
| Address |
Department of Respiratory medicine, Saveetha medical college and hospital, Saveetha institute of medical and technical sciences, Saveetha nagar, Thandalam, Chennai, India
Chennai TAMIL NADU 602105 India |
| Phone |
9884655544 |
| Fax |
|
| Email |
anbumaran.mbbs@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
ANBU MARAN PM |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Saveetha medical college and hospital |
| Address |
Department of Respiratory medicine, Saveetha medical college and hospital, Saveetha institute of medical and technical sciences, Saveetha nagar, Thandalam, Chennai, India
Chennai TAMIL NADU 602105 India |
| Phone |
9884655544 |
| Fax |
|
| Email |
anbumaran.mbbs@gmail.com |
|
|
Source of Monetary or Material Support
|
| SIMATS (Saveetha institute of medical and technical sciences), Saveetha nagar, Thandalam, Chennai 602105 |
|
|
Primary Sponsor
|
| Name |
SIMATS (Saveetha Institute of Medical and Technical Sciences) |
| Address |
Saveetha Medical college and hospital, Saveetha nagar, Thandalam, Chennai 602105 |
| 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 JESVANTHAN E |
Saveetha medical college and hospital |
Ward 421, Department of Respiratory medicine, Saveetha institute of medical and technical sciences, Saveetha nagar, Thandalam, Chennai. Chennai TAMIL NADU |
9442042428
jesvanthanelango@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Medical College and HospitalInstitutionalEthicsCommittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J989||Respiratory disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients aged 18 years and above
2.Individuals diagnosed with respiratory conditions such as chronic obstructive pulmonary disease (COPD), asthma, pneumonia, interstitial lung disease, tuberculosis, or other relevant respiratory pathologies
3.Patients admitted to inpatient wards and intensive care units (ICU)
4.Availability of critical biochemical, microbiological, cytological reports
5.Cases where any biochemical, microbiological, cytological parameters fall within defined critical thresholds that require urgent medical intervention
6.Patients or their legal representatives must provide informed consent to participate in the study |
|
| ExclusionCriteria |
| Details |
1.Patients under the age of 18 years or those whose age is not documented or unavailable
2.Patients without a primary diagnosis of respiratory diseases such as chronic obstructive pulmonary disease (COPD), asthma, pneumonia, tuberculosis, interstitial lung disease, lung malignancies etc
3.Patients with incomplete or unavailable laboratory results during the study period
4.Patients or their legal representatives do not provide informed consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time from critical value generation to clinician notification (minutes); proportion of critical alerts acknowledged within predefined time; rate of missed critical values; change in adverse event incidence related to delayed reporting; time to clinical intervention after alert; user response time across multidisciplinary teams. |
day 1, day 180 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
16/03/2026 |
| 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="8" Days="0" |
|
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
|
The invention not only improves patient safety by ensuring critical conditions are promptly identified, but it also enhances clinical workflow by reducing the cognitive burden on healthcare providers. It streamlines the process of diagnostic review and helps clinicians to prioritize care based on the severity of the patient’s condition, ultimately improving patient outcomes and reducing the risk of complications. In summary, this invention offers an integrated, automated solution to the challenge of managing complex diagnostic data in respiratory medicine. By combining multiple test results into a unified alerting system, it provides healthcare professionals with timely, actionable insights, thereby enhancing early detection, patient monitoring, and clinical decision making in the management of respiratory diseases. The primary goal of this application is to ensure timely intervention by notifying healthcare providers of any potentially life threatening results. By analyzing diagnostic data, the application can detect deviations from normal values and issue immediate alerts to the relevant medical personnel, enabling them to take swift action. This proactive approach improves response times, reduces the risk of complications, and enhances overall patient outcomes, particularly in critical situations. The system is designed to support clinical decision-making by prioritizing alerts based on the severity of the findings, ensuring that critical values are addressed promptly. It also helps reduce the likelihood of human error and ensures that no critical information is overlooked, especially during busy or high pressure moments in clinical settings. Overall, this application is a vital tool in the efficient management of respiratory patients, promoting patient safety, improving clinical workflows and ultimately leading to better healthcare outcomes. |