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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  
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 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  
Status 
Not Applicable 
 
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.

 

 
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