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CTRI Number  CTRI/2019/12/022450 [Registered on: 20/12/2019] Trial Registered Prospectively
Last Modified On: 16/12/2019
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective observational study 
Study Design  Single Arm Study 
Public Title of Study   Determining the correlation between echocardiographic blood flow velocity changes and breath holding maneuver to evaluate whether a hypotensive patient on ventilator support will be benefitted by further intravenous fluid therapy 
Scientific Title of Study   Use of pulmonary arterial velocity time integral variation and effect of inspiratory pause in predicting fluid responsiveness in acute circulatory failure 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shanmugam R 
Designation  senior resident 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Department of Anaesthesiology Pain Medicine & Critical Care, Room no: 5011, 5th Floor, Teaching Block, All India Institute of Medical Sciences, New Delhi

South West
DELHI
110017
India 
Phone  8810516233  
Fax    
Email  roshanmugam@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dilip Shende 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Department of Anaesthesiology Pain Medicine & Critical Care, Room no: 5011, 5th Floor, Teaching Block, All India Institute of Medical Sciences, New Delhi

South West
DELHI
110017
India 
Phone  8800377697  
Fax    
Email  dilipshende@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shanmugam R 
Designation  senior resident 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Department of Anaesthesiology Pain Medicine & Critical Care, Room no: 5011, 5th Floor, Teaching Block, All India Institute of Medical Sciences, New Delhi

South West
DELHI
110017
India 
Phone  8810516233  
Fax    
Email  roshanmugam@gmail.com  
 
Source of Monetary or Material Support  
ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI 
 
Primary Sponsor  
Name  ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI 
Address  ALL INDIA INSTITUTE OF MEDICAL SCIENCES, ANSARI NAGAR, NEW DELHI 110029 
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 
Shanmugam R  All India Institute of Medical Sciences  AB8 ICU, Department of Anaesthesiology Pain Medicine & Critical Care, 8th Floor, Ward Block, All India Institute of Medical Sciences, New Delhi
South West
DELHI 		 8810516233

roshanmugam@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institute ethics committee for postgraduate research , AIIMS, Ansari Nagar, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I00-I99||Diseases of the circulatory system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Mechanically ventilated patients of age 18 years and more admitted in the ICU.
2.Patients with Acute circulatory failure – presence of any one of the following.
-Systolic blood pressure <90 mm Hg or MAP < 65 mmHg
-Need of vasopressors to maintain systolic blood pressure > 90 mmHg.
-Urine output < 0.5ml/kg/hour for 2 hours
-Heart rate > 100 /min
 
 
ExclusionCriteria 
Details  Patients not in sinus rhythm
Patients with low tidal volumes (less than 6 ml/kg)
Patients with known cardiac valvular dysfunction
Right heart failure
Patients with very high respiratory rate (HR/RR <3.6)
Morbid obesity-BMI ≥35 kg/m2
Poor echocardiographic window 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the correlation between pulmonary arterial velocity time integral variation, aortic velocity time integral variation and inspiratory pause maneuver to predict fluid responsiveness in mechanically ventilated patients with acute circulatory failure.  1 day 
 
Secondary Outcome  
Outcome  TimePoints 
To determine sensitivity, specificity, positive predictive value and negative predictive value of pulmonary arterial velocity time integral variation, aortic velocity time integral variation and inspiratory pause maneuver to predict fluid responsiveness in mechanically ventilated patients with acute circulatory failure.  1 day 
 
Target Sample Size   Total Sample Size="101"
Sample Size from India="101" 
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)   25/12/2019 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Fluid administration is the first-line therapy in patients with acute circulatory failure. Except in cases of cardiogenic shock, fluid depletion or hypovolemia is the primary cause of acute circulatory failure. Hence fluid resuscitation is essential in the early phases of shock, particularly in cases of sepsis. In our prospective observational study, we plan to compare pulmonary arterial velocity time integral variation, Aortic velocity time integral variation and inspiratory pause maneuver to predict fluid responsiveness in mechanically ventilated, acute circulatory failure patients.

 
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