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CTRI Number  CTRI/2025/06/089886 [Registered on: 30/06/2025] Trial Registered Prospectively
Last Modified On: 28/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   "Tidal Volume Challenge :A Practical Tool to Guide Fluid Therapy in the Critically Ill" 
Scientific Title of Study   Tidal Volume Challenge to Reliably Predict Fluid Responsivness in Critically ill patient 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Alka Kumari 
Designation  Senior Resident 
Affiliation  Indira Gandhi Institute of Medical Science, Patna 
Address  Department of Critical Care Medicine
IGIMS, Patna
Patna
BIHAR
800014
India 
Phone  8521458625  
Fax    
Email  alkachoudhary874@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ritu Singh  
Designation  Associate professor  
Affiliation  Indira Gandhi Institute of Medical Science, Patna 
Address  Department of Critical Care Medicine
IGIMS, Sheikhpura Patna

BIHAR
800014
India 
Phone  8127395753  
Fax    
Email  ritusingh140@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Alka Kumari 
Designation  Senior Resident 
Affiliation  Indira Gandhi Institute of Medical Science, Patna 
Address  Department of Critical Care Medicine
IGIMS , Sheikhpura, Patna
Patna
BIHAR
800014
India 
Phone  8521458625  
Fax    
Email  alkachoudhary874@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  IGIMS 
Address  Dean Academics , IGIMS patna 
Type of Sponsor  Government medical college 
 
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 
Ritu Singh   Indira Gandhi institute of medical Sciences,patna  Department of critical care medicine
Patna
BIHAR 
8127395753

ritusingh140@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J99||Respiratory disorders in diseasesclassified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL   Nil 
Intervention  Tidal Volume Changes   Adult patients (18 Years) with hemodynamic instability who are intubated and mechanically ventilated with volume assist-control ventilation (ACV) and using low tidal volume strategy (6 ml/kg/IBW). All patients were fully sedated and not on vasopressors or receiving stable doses of vasopressors. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Adult patients more than 18 years with hemodynamic instability who are intubated and mechanically ventilated with volume assist-control and using low tidal volume strategy  
 
ExclusionCriteria 
Details  1. Age less than 18 years
2.Contraindication for PPV( Spontaneous breathing,cardiac arrthymias,open chest,right-side heart failure,pulmonary or intraabdominal hypertension)
3. Non consenting  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To Study to compare the sensitivity and specificity of both tests for the prediction of fluid responsiveness in mechanically ventilated patients with hemodynamic instability  18 month  
 
Secondary Outcome  
Outcome  TimePoints 
1. See compare hemodynamic changes in 2 groups
2. Side effect of fluid bolus
3. Identify non responder to fluid therapy  
18 month 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   30/07/2025 
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="1"
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  

          Volume expansion is a cornerstone treatment of acute circulatory failure like during the early hours in patients with septic shock, but it can be a cause of therapeutic dilemma because fluid overload can lead to acute kidney injury, prolongation of mechanical ventilation, acute respiratory distress syndrome, and higher mortality rates.

       Predicting fluid responsiveness with a reliable, easy, and rapid way is essential to know when to start and when to stop fluid therapy especially as patients may react differently to VE.

         Static hemodynamic parameters like inferior vena cava diameter and central venous pressure are unreliable and cannot predict FR precisely; contrarily, dynamic parameters that depend on cyclic changes in cardiac preload caused by mechanical ventilation, leading to variation of stroke volume or pulse pressure have proven to be reliable when predicting FR in hemodynamically unstable patient

       PPV is a common dynamic parameter that can predict FR reliably and can be recorded through most of recent bedside monitors easily using arterial lines; also, it does not need CO monitoring or any other maneuvers to be done.

 


 
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