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
|
|
Primary Sponsor
|
Name |
IGIMS |
Address |
Dean Academics , IGIMS patna |
Type of Sponsor |
Government medical college |
|
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 |
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
|
|
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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