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CTRI Number  CTRI/2021/03/031921 [Registered on: 11/03/2021] Trial Registered Prospectively
Last Modified On: 19/10/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective 
Study Design  Other 
Public Title of Study   To evaluate the role of electrical cardiometry for assessing response to fluid administration by measuring cardiac output before and after raising the leg in patients with sudden fall in blood pressure or with signs of low blood pressure and to compare it with transthoracic echocardiography 
Scientific Title of Study   Evaluation of electrical cardiometry to assess fluid responsiveness by tracking PLR-induced change in cardiac output in patients with acute circulatory failure: A comparison study with transthoracic echocardiography  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shashikant Sharma 
Designation  Senior Resident 
Affiliation  All India Institute of Medical Sciences 
Address  Room no-5011, 5th Floor, Teaching Block Department of Anaesthesiology, Pain Medicine and Critical Care AIIMS, New Delhi

South
DELHI
110029
India 
Phone  8427482860  
Fax    
Email  aiimspgi2840@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anjan Trikha 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room No-5011, 5th Floor, Teaching Block, Department Of Anaesthesiology, Pain Medicine and Critical Care AIIMS, New Delhi

South
DELHI
110029
India 
Phone  9810977901  
Fax    
Email  anjantrikha@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shashikant Sharma 
Designation  Senior Resident 
Affiliation  All India Institute of Medical Sciences 
Address  Room No-5011, 5th Floor, Teaching Block, Department Of Anaesthesiology, Pain Medicine and Critical Care AIIMS, New Delhi

South
DELHI
110029
India 
Phone  8427482860  
Fax    
Email  aiimspgi2840@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, Pain Medicine and Critical Care AIIMS, NEW DELHI 
 
Primary Sponsor  
Name  Department of Anaesthesiology Pain Medicine and Critical Care AIIMS NEW DELHI 
Address  8th Floor, Main OT complex, AIIMS, NEW DELHI 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
not applicable   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
SHASHIKANT SHARMA  All India Institute of Medical Sciences  AB8 ICU, 8th Floor, Main OT complex, AIIMS, New Delhi
South
DELHI 		 08427482860

aiimspgi2840@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I959||Hypotension, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients (18-65 years) with an arterial catheter in situ, on controlled mechanical ventilation and at least one of the following signs of circulatory failure:
1.systolic blood pressure ≤ 90 mmHg or fall > 50 mm Hg in previously hypertensive patients
2.The requirement of vasopressor drugs
3.urine output ≤ 0.5 ml/kg/hr during at least two hours
4.Heart rate > 100 beats/minute
5.Presence of skin mottling or delayed capillary refilling (> 3 seconds)
 
 
ExclusionCriteria 
Details  1. age<18 years and >65 years
2. pregnancy
3. patient with arrhythmias
4. known case of heart failure on treatment
5. patients with lower limb amputation
6. patient with valvular heart diseases
7. contraindications to performing PLR (Lower limb DVT, Limb/pelvic fracture, abdominal surgeries, intra-abdominal hypertension, intracranial hypertension
8. presence of wound/dressing in the neck
9. difficulty in getting adequate echo window (morbid obese[BMI> 40 Kg/square metre],chest wall trauma)
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To measure bias, mean, and limits of agreement for cardiac output obtained with Electrical cardiometry and those obtained by transthoracic echocardiography, before and after passive leg raising in patients with acute circulatory failure.  the outcome will be assessed at the end of study period 
 
Secondary Outcome  
Outcome  TimePoints 
a. To measure the change in heart rate, systolic, diastolic, mean arterial pressure, and Central venous pressure
b. To measure the change in ventilatory parameters (peak airway pressure and mean airway pressure)
c. To compare the dose and type of vasoactive drugs in fluid responders and non-responder group
 		 before and after passive leg raising 
 
Target Sample Size   Total Sample Size="125"
Sample Size from India="125" 
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)   20/03/2021 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  		 NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 sepsis is common in intensive care patients and such patients receive fluids as initial care to maintain blood pressure and ensure adequate oxygen delivery to the tissues. However, only 50% of patients respond to fluid administration and excess of fluid has shown to cause harm. Therefore, identification of fluid responders is important. There are multiple techniques to assess fluid responsiveness and change in cardiac output after passive leg raising is one of them. It is simple and does not cause harm by avoiding exogenous administration of fluids. Electrical cardiometry is simple, easy to use and non-invasive device and can be used in place of transthoracic echocardiography for monitoring change in cardiac output. This study aims to evaluate the role of electrical cardiometry for trending of cardiac output in patients with acute circulatory failure. 
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