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CTRI Number  CTRI/2025/07/090504 [Registered on: 08/07/2025] Trial Registered Prospectively
Last Modified On: 26/06/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Retrospective analysis to find whether a relationship exists between the timing of chest imaging and the finding of a positive diagnosis that can change the treatment of patients admitted to the intensive care unit with nonimproving lower respiratory tract infection. 
Scientific Title of Study   Association of clinically significant diagnostic yield with the timing (early versus late) of computed tomography of the chest in critically ill patients with nonresponding pneumonia: A retrospective analysis from a tertiary care center. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Meenupriya Arasu 
Designation  Senior Resident 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Department of Anaesthesiology and Critical care, Academic section, 5th floor, AIIMS, Ansari nagar, New Delhi, India

New Delhi
DELHI
110029
India 
Phone  7708024354  
Fax    
Email  meenupriya1193@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vimi Rewari 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Department of Anaesthesiology and Critical care, Academic section, 5th floor, AIIMS, Ansari nagar, New Delhi, India

New Delhi
DELHI
110029
India 
Phone  9818304880  
Fax    
Email  vimirewari@gmail.com  
 
Details of Contact Person
Public Query  
Name  Meenupriya Arasu 
Designation  Senior Resident 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Department of Anaesthesiology and Critical care, Academic section, 5th floor, AIIMS, Ansari nagar, New Delhi, India


DELHI
110029
India 
Phone  7708024354  
Fax    
Email  meenupriya1193@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Scineces, AIIMS, New Delhi 
 
Primary Sponsor  
Name  AIIMS 
Address  Research and Intramural Grant, AIIMS, New Delhi 
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 Meenupriya Arasu  All India Institute of Medical Sciences (AIIMS)  Department of Anaesthesiology and Critical care, Academic section, 5th floor, AIIMS, Ansari nagar
New Delhi
DELHI 		 7708024354

meenupriya1193@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee for Postgraduate Research, AIIMS, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J168||Pneumonia due to other specified infectious organisms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Patients admitted to the ICU who underwent CT chest for evaluation of nonresponding pneumonia after 72 hours of starting or a change in the antibiotic therapy.
2.If multiple imaging is being done for the same patient, the outcome of each scan will be counted separately.
 
 
ExclusionCriteria 
Details  1.Patients who did not undergo any CT chest during their ICU stay.
2.Patients who underwent CT chest before or within 72 hours of the commencement of antibiotic therapy.
3.Patients with incomplete data on the day of commencement of antibiotic therapy before admission.
4.CT scan done before ICU admission.
5.CT scans performed for indications other than NRP or for interventional imagery, such as a CT pulmonary embolism or CT scan-guided procedures that the patient underwent.
6.Pregnancy
7.Known case of pulmonary tuberculosis, malignancy and bronchiectasis.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the association of treatment change event rate with the timing of CT chest (early versus late) in critically ill patients with nonresponding pneumonia.  After approval by CTRI, the data will be collected from ICU charts will be reviewed by retrospective chart review at the following timepoints:
1.On the day of ICU admission for baseline data.
2.On the day of CT chest imaging and next day for the diagnostic yield and any treatment change event
3.Till the last day of ICU stay for estimation of duration of ICU stay, mechnical ventilation outcomes and mortality.
 
 
Secondary Outcome  
Outcome  TimePoints 
1.To compare the sensitivity & specificity of the early versus late CT chest.
2.To compare the correlation of the CT findings with the final microbiological diagnosis in early versus late CT chest groups.
3.To evaluate the following differences in those who underwent early versus late CT chest for the evaluation of NRP.
-Difference in the time to clinical stability
-Difference in the length of mechanical ventilation
-Difference in length of ICU stay
-Difference in ICU mortality
4.To identify the clinical predictors associated with a positive diagnosis on CT chest in patients with NRP. 		 After approval by CTRI, the data will be collected from ICU charts will be reviewed by retrospective chart review at the following timepoints:
1.On the day of ICU admission for baseline data.
2.On the day of CT chest imaging & next day for the diagnostic yield & any treatment change event
3.Till the last day of ICU stay for estimation of duration of ICU stay, mechnical ventilation outcomes & mortality. 
 
Target Sample Size   Total Sample Size="268"
Sample Size from India="268" 
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)   27/07/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 incidence of nonresponding pneumonia ranges from 10 to 15 percentage in community-acquired and 30 to 60 percentage in nosocomial pneumonia. Chest computed tomography is an indispensable diagnostic and management tool for critically ill patients with nonresponding pneumonia. It enhances diagnostic accuracy, identifies alternative diagnoses, assesses disease severity, monitors progression, and aids in interventional procedures. However, its use should be balanced against potential risks and resource limitations, ensuring it is applied judiciously in clinical practice. Appropriate timing of the CT is crucial to derive clinically significant finding which will be beneficial for treatment of the patient.  Hence, we conduct this study to find if the clinically significant findings in early or late CT chest impacts treatment outcomes in critically ill patients with nonresponding pneumonia.  We also aim to identify other risk factors associated with a clinically significant diagnosis. This can help in better timing and patient selection for CT chest to improve treatment outcomes of critically ill patients with nonresponding pneumonia.

 
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