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CTRI Number  CTRI/2024/04/064995 [Registered on: 01/04/2024] Trial Registered Prospectively
Last Modified On: 29/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   A comparison of pulse pressure variability and inferior vena cava dispensability index for predicting fluid responsiveness 
Scientific Title of Study   A comparative study of pulse pressure variability and inferior vena cava dispensability index for evaluation of fluid responsiveness at 2 different tidal volumes during mechanical ventilation 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sona Dave 
Designation  Professor 
Affiliation  TNMC BYL Nair Ch. Hospital 
Address  Department of Anaesthesia, 403, Fourth floor, College Building, TNMC BYL Nair Ch. Hospital A L Nair Road, Mumbai central, Mumbai
4C Bindiya, Bandra Reclamation Road, Bandra west, Mumbai 400050
Mumbai
MAHARASHTRA
400008
India 
Phone  09820067731  
Fax    
Email  sonadave@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sona Dave 
Designation  Professor 
Affiliation  TNMC BYL Nair Ch. Hospital 
Address  Department of Anaesthesia, 403, Fourth floor, College Building, TNMC BYL Nair Ch. Hospital A L Nair Road, Mumbai central, Mumbai
4C Bindiya, Reclamation area, Bandra west, Mumbai 400050
Mumbai
MAHARASHTRA
400008
India 
Phone  09820067731  
Fax    
Email  sonadave@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Yogesh Ganesh Chawat 
Designation  Junior Registrar 
Affiliation  TNMC BYL Nair Ch. Hospital 
Address  Department of Anaesthesia, 403 Fourth floor, College building,
A L Nair Road, Mumbai Central Mumbai
Mumbai
MAHARASHTRA
400008
India 
Phone  09820067731  
Fax    
Email  yugalkirtan.rns@gmail.com  
 
Source of Monetary or Material Support  
TNMC and BYL Nair Ch. Hospital, A L Nair Road, Mumbai Central, Mumbai. PIN 400008 
 
Primary Sponsor  
Name  TNMC and BYL Nair Ch. Hospital 
Address  TNMC and BYL Nair Ch. Hospital Mumbai Central Mumbai 400008 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
self  TNMC and BYL Nair Ch. Hospital 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sona Dave  TNMC BYL Nair Ch Hospital  Department of Anaesthesia, 403, Fourth floor, College building, Mumbai Central , Mumbai 400008
Mumbai
MAHARASHTRA 
09820067731

sonadave@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee for Academic Research Projects (ECARP)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: G939||Disorder of brain, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Fluid challenge  Fluid challenge: Ringers lactate solution will be infused intravenously over a 10-min period with a total infusion volume of 6 mL per kg that served to observe fluid responsiveness. The parameters will be noted with tidal volumes of 8 and 10 mL per kg before and immediately after the fluid challenge. Total duration will be 18 minutes.  
Comparator Agent  Same patient will be assessed post intervention.  Fluid challenge: Ringers lactate solution will be infused intravenously over a 10-min period with a total infusion volume of 6 mL per kg that served to observe fluid responsiveness. The parameters will be noted with tidal volumes of 8 and 10 mL per kg before and immediately after the fluid challenge. Total duration will be 18 minutes.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients posted for routine major surgeries in plastic and neurosurgery OT under general anaesthesia and mechanical ventilation
Arterial cannulation done as a part of routine protocol
ASA 1 and 2 
 
ExclusionCriteria 
Details  Pregnancy,
Patients with cardiac and respiratory ailments
Raised intracranial pressure
Contraindication of fluid challenge (acute coronary syndrome, cardiac shock, and evidence of
capacity overload)  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Accuracy of PPV in predicting volume responsiveness can be increased by increasing TV. Optimal TV that enables best diagnostic value is 10 ml/kg. The diagnostic value of PPV is higher than that of IVC DI.  TV adjustment will be carried out after about 10 min when the hemodynamics of the patient
become stable.
The TV will be adjusted to 8 mL/kg.
The parameters will be recorded.
The TV will be adjusted to 10 mL/kg after 2 min.
The indices will be recorded after maintenance for 2 min.
Then Fluid challenge will be given.
The tidal volumes of 8 and 10 mL/kg will be adjusted immediately after the fluid challenge and
maintained for 2 min, and then the above indices will be recorded again.
 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in VTI with fluid challenge  TV adjustment will be carried out after about 10 min when the hemodynamics of the patient
become stable.
The TV will be adjusted to 8 mL/kg.
The parameters will be recorded.
The TV will be adjusted to 10 mL/kg after 2 min.
The indices will be recorded after maintenance for 2 min.
Then Fluid challenge will be given.
The tidal volumes of 8 & 10 mL/kg will be adjusted immediately after the fluid challenge and
maintained for 2 min, & then the above indices will be recorded again.
 
 
Target Sample Size   Total Sample Size="39"
Sample Size from India="39" 
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)   10/04/2024 
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="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  

Hypovolemia leading to hypotension after induction of anaesthesia is common occurrence due to action of anaesthetic drugs and pre-op starvation. Intra operative hypotension has been implicated as major contributing factor for post-operative morbidity; it may prolong hospital stay and is associated with major postoperative complications including acute kidney injury, myocardial injury and death. Thus, intra-operative fluid resuscitation plays a major role in maintaining the hemodynamic stability in surgical patients This study is a comparative study of pulse pressure variability and inferior vena cava dispensability index for evaluation of fluid responsiveness at 2 different tidal volumes during mechanical ventilation. Approval for conducting the study will be taken from Institutional Ethics Committee. Patients for the study will be selected by simple random sampling method from those who fulfil the inclusion criteria. A multipara monitors with facility to measure PPV from arterial pressure waveforms and record vital signs of the patients will be used. Routine anaesthesia induction with 1.5–2.5 mg/kg Propofol, 0.5 mg/kg Atracurium (0.6– 1.0 mg/kg Rocuronium) .TV adjustment will be carried out after about 10 min when the hemodynamics of the patient become stable. If hypotension occurs during the surgery before giving bolus, it will be treated as per standard protocol by fluid infusion or drug therapy. The TV will be adjusted to 8 mL/kg and the respiratory rate will be maintained at 9 cycles/min. Heart rate (HR), diastolic blood pressure, systolic blood pressure, mean arterial pressure (MAP), PPV, peak pressure (Ppeak), plateau pressure, the VTI of the left ventricular outflow tract, and IVC-DI will be recorded. The velocity-time integral (VTI) of the left ventricular outflow tract will be measured by transthoracic echocardiography. Blood flow of the left ventricular outflow tract will be recorded by pulsed Doppler echocardiography on an apical five-chamber view. Sample volume lines will be placed in the aortic annulus and VTI will be measured. The IVC diameter (IVC inspiration/IVC expiration) will be measured at the subxiphoid transabdominal long axis, the position of the section will be 2–3 cm from the distal end of the right atrial opening of the IVC. The diameter of the IVC at the end of inspiration (IVC inspiration) and the diameter of the IVC at the end of expiration (IVC expiration) will also be measured. The IVC-DI is calculated as (IVCinspiratory - IVCexpiratory)/ IVCexpiratory X 100%. The TV will be adjusted to 10 mL/kg and the respiratory rate will be maintained at 9 cycles/min. The indices will be recorded after maintenance for 2 min and the airflow will be maintained at 1L/min. So, Measurements will be taken for total of 4 times -2 times before fluid infusion and 2 times after fluid infusion. Before and after fluid infusion, tidal volume will be adjusted to 8 and 10 ml/kg. After each adjustment measurements will be taken. Fluid challenge: Ringer’s lactate solution (RL) will be infused intravenously over a 10-min period with a total infusion volume of 6 mL/kg that served to observe fluid responsiveness. The tidal volumes of 8 and 10 mL/kg will be adjusted immediately after the fluid challenge and maintained for 2 min, and then the above indices will be recorded again.  There is no grouping done before the study. Patients with an increased VTI of the left ventricular outflow tract (â–² VTI) ⩾15% after the fluid challenge will be classified as fluid responsive (R group) and patients with a â–² VTI of < 15% will be analysed and classified as fluid non-responsive (NR group).

 
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