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CTRI Number  CTRI/2024/02/063146 [Registered on: 26/02/2024] Trial Registered Prospectively
Last Modified On: 06/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Other (Specify) [Tidal Volumn Challange and Fluid Therapy]  
Study Design  Single Arm Study 
Public Title of Study   The study investigates if a brief breath volume change in a ventilator-induced patient can indicate fluid therapy response by detecting pulse pressure changes in severe breathing patients receiving breaths through machines and in a prone position. 
Scientific Title of Study   Change in PPV with Tidal Volume Challenge to assess fluid responsiveness in patients suffering from Acute Respiratory Distress Syndrome undergoing low tidal volume mechanical ventilation in prone position 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Project No 4237 Version 2.0 dated 7 Oct 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sheila N Myatra 
Designation  Professor 
Affiliation  Tata Memorial Hospital, Mumbai 
Address  Dept of Anesthesia, Critical Care and Pain, Main Building, Second Floor, Dr E Borges Road, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9820156070  
Fax    
Email  sheila150@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sheila N Myatra 
Designation  Professor 
Affiliation  Tata Memorial Hospital, Mumbai 
Address  Dept of Anesthesia, Critical Care and Pain, Main Building, Second Floor, Dr E Borges Road, Parel, Mumbai


MAHARASHTRA
400012
India 
Phone  9820156070  
Fax    
Email  sheila150@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Masood Ali Mujawar 
Designation  Senior Resident 
Affiliation  Tata Memorial Hospital, Mumbai 
Address  Dept of Anesthesia, Critical Care and Pain, Main Building, Second Floor, Dr E Borges Road, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9503338184  
Fax    
Email  masoodmujawar864@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital, Dr E Borges Road, Parel, Mumbai-12 
 
Primary Sponsor  
Name  Tata Memorial Hospital, Mumbai 
Address  Dr E Borges Road, Parel, Mumbai, Maharashtra 400012 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
None  None 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Masood Ali Mujawar  Tata Memorial Hospital, Mumbai  MB171, MB 271 Intensive care Unit, Main Building, First and Second floor, Dr E Borges Room, Parel,
Mumbai
MAHARASHTRA 
98503338184

masoodmujawar864@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Tata Memorial Centre-Institutional Ethics Committee  Approved 
Tata Memorial Centre-Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J960||Acute respiratory failure, (2) ICD-10 Condition: 4||Measurement and Monitoring,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Baseline values  Participants baseline reading of variables before tidal volume challenge and after fluid bolus will be used as comparator 
Intervention  Fluid Bolus   a fluid bolus of 250 ml of Ringers Lactate will be given over 10 minutes, and measurements will be repeated. 
Intervention  tidal volume challenge  The tidal volume challenge will be performed by increasing Vt to 8 mL/kg PBW, and pulse contour cardiac index, PPV, and SVV will be recorded after 1 minute and change in PPV and SVV (delta PPV(VT) and delta-SVV(VT) will be calculated) 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1 Adult patients Age more than 18 years
2 Suffering From Acute Respiratory Distress Syndrome ARDS defined as per Berlins Criteria.
3 Undergoing mechanical ventilation via lung protective low tidal volume strategy using Volume assist control ventilation without any spontaneous breathing activity (deeply sedated/ paralyzed as seen on pressure time curve on ventilator), in prone position.
4 Having invasive continuous cardiac output monitoring using PICCO device (Pulsion Medical Systems, Feldkirchen, Germany) with Phillips Intel View monitor MP700
5 Patients of acute circulatory failure defined as the presence of systolic blood pressure (SBP) less than or equal to 90 mm Hg or mean arterial pressure (MAP) less than or equal to 70 mm Hg or requiring vasopressors to maintain SBP more than 90 or MAP more than 70 along with one or more of the following: a) urine flow less than 0.5 mL per kg per hr for more than 2hours. b) heart rate more than 100 beats per minute. c) Presence of skin mottling d) blood lactate concentration more 2 mmol per L in whom the treating physician plans to give a fluid bolus
 
 
ExclusionCriteria 
Details  1 Age less than 18 years.
2 Patients with cardiac arrythmia, known valvular heart disease, intracardiac shunt, right ventricular dysfunction, air leakage through chest drains, abdominal compartment syndrome.
3 Pregnant Females
4 Patient refusing consent to participate in the study
5 Extravascular Lung water Index (EVLWI) >12 (except in those patients in whom treating clinician wishes to give a fluid bolus to the patient) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess whether change in PPV while transiently increasing tidal volume to 8ml per kg Predicted Body Weight in patients suffering from ARDS undergoing low tidal volume ventilation in prone position adequately predicts fluid responsiveness.  30 min after starting the intervention 
 
Secondary Outcome  
Outcome  TimePoints 
To study the effect of lung compliance on the validity of tidal volume challenge test to predict fluid responsiveness in patients suffering from ARDS undergoing low tidal volume ventilation in prone ventilation.  1 months after starting the trial enrollment 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   Phase 3 
Date of First Enrollment (India)   04/03/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Patients admitted in ICU with septic shock (spread of infection in blood) caues low blood pressure. The first line of treatment for this is administration of intraveous fluids called as Fluid therapy. This fluid therapy, which involves the rapid administration of fluids in the patient’s veins, stands as one of the fundamental treatment modalities employed in patients afflicted by low blood pressure stemming from infection, otherwise known as septic shock. However, it is worth noting that only a minority of patients, specifically 50%, exhibit a positive response to fluid therapy, evidenced by an increase in blood pressure and an amelioration of blood supply to various organs, consequently averting the onset of organ failure.

In cases where patients display an unresponsiveness to fluid therapy, the administration of fluids may result in deleterious consequences, such as fluid accumulation within the lungs, which can precipitate lung congestion, thereby exacerbating the patient’s oxygen requirement. Consequently, the ability to accurately predict fluid responsiveness assumes paramount importance in the effective management of patients. In light of this, several tests have been devised with the aim of forecasting which patients will exhibit a favorable response to fluid therapy. However, the challenge lies in those patients who are placed in a prone position, that is, made to lie on their stomach for the purpose of ventilation, as part of their lung problems treatment. This specific group of patients presents a unique issue due to the lack of standardized tests available and the technical difficulties encountered when attempting to perform the existing tests.

To evaluate the effectiveness of the tidal volume challenge test, we are currently investigating one specific test. This test involves making adjustments to the ventilator settings in order to regulate the amount of breath administered to the patient. The breath volume is adjusted from 6ml/kg weight to 8ml/kg weight, and the test is conducted for a duration of 1 minute. The objective of this test is to observe the response in pulse pressure. Additionally, we will also assess the impact of administering fluids on the patient’s heart function. This will allow us to determine whether the reliability of pulse pressure variation (PPV) improves after measuring it following an increase in breath volume to 8ml/kg. By conducting this study, we aim to determine whether the change in PPV, while transiently increasing tidal volume to 8ml/kg Predicted Body Weight (PBW) in patients suffering from Acute Respiratory Distress Syndrome (ARDS) undergoing low tidal volume ventilation in the prone position, sufficiently predicts fluid responsiveness.

In order to examine the impact of lung compliance on the accuracy and reliability of the tidal volume challenge test, which aims to predict fluid responsiveness in patients who are experiencing acute respiratory distress syndrome (ARDS) and are undergoing low tidal volume ventilation in the prone position, it is crucial to thoroughly investigate the outcomes of this test. If the test produces favorable and encouraging results, it could potentially serve as a valuable and beneficial tool in the management and treatment of patients who are similar to yours, ultimately leading to improved patient care and outcomes.

 
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