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CTRI Number  CTRI/2025/01/078968 [Registered on: 20/01/2025] Trial Registered Prospectively
Last Modified On: 18/01/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Other 
Public Title of Study   Comparing the quality of chest X-rays in patients after heart surgery on ventilators, taken randomly during breathing versus during a moment when the ventilator briefly holds the breath. 
Scientific Title of Study   Comparison of chest X-ray quality in post- cardiac surgery patients on invasive positive pressure ventilation, acquired during a random phase of ventilation versus during an inspiratory pause. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bala Sivanandan S 
Designation  Nursing Practitioner 
Affiliation  Narayana Health 
Address  Adult Cardiac Surgery, 2nd floor and 4th floor,Narayana Institute Of Cardiac Sciences, Narayana Health, Bomassandra

Bangalore
KARNATAKA
560099
India 
Phone  7530063925  
Fax    
Email  balasivanandan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Bala Sivanandan S 
Designation  Nursing Practitioner 
Affiliation  Narayana Health 
Address  Adult Cardiac Surgery, 2nd floor and 4th floor,Narayana Institute Of Cardiac Sciences, Narayana Health, Bomassandra


KARNATAKA
560099
India 
Phone  7530063925  
Fax    
Email  balasivanandan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Bala Sivanandan S 
Designation  Nursing Practitioner 
Affiliation  Narayana Health 
Address  Adult Cardiac Surgery, 2nd floor and 4th floor,Narayana Institute Of Cardiac Sciences, Narayana Health, Bomassandra


KARNATAKA
560099
India 
Phone  7530063925  
Fax    
Email  balasivanandan@gmail.com  
 
Source of Monetary or Material Support  
Narayana Health City, 258/A Bommasandra Industrial area, Hosur Road, Bengaluru, 560099  
 
Primary Sponsor  
Name  Bala Sivanandan S 
Address  Narayana Institue of Cardiac Sciences, Narayna Health, Bomassandra, Bengaluru 
Type of Sponsor  Other [Self] 
 
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 
Bala Sivanandan S  Narayana Institute Of Cardiac Sciences, Narayana Health  Adult Cardiac surgical ICU, 2nd Floor and 4th Floor, Dept of Intensive Care Unit ,Narayana Institute Of Cardiac Sciences
Bangalore
KARNATAKA 		 7530063925

balasivanandan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Narayana Health Academic Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z488||Encounter for other specified postprocedural aftercare,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Chest X-ray will be obtained as per the routine treatment procedure.  Baseline only 
Intervention  Chest x-ray will be obtained during an Inspiratory hold maneuver for 5 seconds.  Baseline only 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Post cardiac surgery requiring invasive mechanical ventilation.
2. Patients receiving sedation and skeletal muscle relaxants with no spontaneous respiratory efforts 
 
ExclusionCriteria 
Details  1. Age less than 18 years
2. Patients with spontaneous respiratory efforts
3. Conscious patients
4. Denial of consent. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the quality of chest X-ray images obtained during the random phase of ventilation versus those acquired during an inspiratory pause in sedated and paralyzed patients on invasive positive pressure ventilation following cardiac surgery.  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the subjective clarity of anatomical structures, lung expansion the diagnostic accuracy in chest X-ray images obtained during standard ventilation versus those acquired with an inspiratory hold.  Baseline 
 
Target Sample Size   Total Sample Size="203"
Sample Size from India="203" 
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)   30/01/2025 
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="0"
Months="6"
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  

Chest X-rays are a crucial diagnostic tool in intensive care units (ICUs), particularly for patients on invasive positive pressure ventilation (IPPV) following cardiac surgeries . However, motion artifacts due to breathing can significantly compromise image quality, hindering accurate interpretation of anatomical structures and lung pathology.

This research investigates the potential benefit of inspiratory hold maneuvers during ventilation on improving chest X-ray image quality in sedated and paralyzed patients on IPPV after cardiac surgery.

 
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