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CTRI Number  CTRI/2024/03/063446 [Registered on: 01/03/2024] Trial Registered Prospectively
Last Modified On: 26/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective observational study 
Study Design  Other 
Public Title of Study   The use of pulse-oximeter derived parameter to determine the need of intravenous fluid supplementation immediately after cardiac surgery in the ICU 
Scientific Title of Study   Ability of plethysmographic perfusion index to detect fluid responsiveness during the immediate post-operative period in cardiothoracic surgery patients – a prospective observational study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Abinaya Prakashbabu U 
Designation  Senior resident 
Affiliation  Sree Chitra Thirunal Institute of Medical Sciences and Technology 
Address  Department of Cardiothoracic and Vascular Anesthesia, SCTIMST Thiruvananthapuram

Thiruvananthapuram
KERALA
695011
India 
Phone  8608289662  
Fax    
Email  abinayaup@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Subin Sukesan 
Designation  Professor 
Affiliation  Sree Chitra Thirunal Institute of Medical Sciences and Technology 
Address  Department of Cardiothoracic and Vascular Anesthesia, SCTIMST Thiruvananthapuram

Thiruvananthapuram
KERALA
695011
India 
Phone    
Fax    
Email  subin@sctimst.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Abinaya Prakashbabu U 
Designation  Senior resident 
Affiliation  Sree Chitra Thirunal Institute of Medical Sciences and Technology 
Address  Department of Cardiothoracic and Vascular Anesthesia, SCTIMST Thiruvananthapuram

Thiruvananthapuram
KERALA
695011
India 
Phone  8608289662  
Fax    
Email  abinayaup@gmail.com  
 
Source of Monetary or Material Support  
Sree Chitra Thirunal Institute of Medical Sciences and technology  
 
Primary Sponsor  
Name  Sree Chitra Thirunal Institute Medical Sciences and Technology 
Address  Department of Cardiothoracic and Vascular anesthesia, SCTIMST, Thiruvananthapuram 
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 
Dr Abinaya Prakashbabu U  Sree Chitra Thirunal Institute of Medical Sciences and Technology  Division of Cardiothoracic & Vascular Anesthesia, Department of Anesthesia, SCTIMST, Thiruvananthapuram
Thiruvananthapuram
KERALA 
8608289662

abinayaup@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I059||Rheumatic mitral valve disease, unspecified, (2) ICD-10 Condition: I069||Rheumatic aortic valve disease, unspecified, (3) ICD-10 Condition: I079||Rheumatic tricuspid valve disease,unspecified, (4) ICD-10 Condition: I089||Rheumatic multiple valve disease,unspecified, (5) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, (6) ICD-10 Condition: I349||Nonrheumatic mitral valve disorder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil, as it is an observational study 
Comparator Agent  Nil  Nil, as it is an observational study 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  All postoperative adult patients scheduled for elective cardiothoracic surgery 
 
ExclusionCriteria 
Details  Refusal to participate
Emergency surgeries
Redo surgery
Severe LV dysfunction
Preoperative inotropic requirement
Arrythmias
Vasoactive-inotrope score of more than 15
Massive blood loss
Patients on renal replacement therapy 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To study the reliability of change in plethysmographic perfusion index for predicting fluid responsiveness immediately following admission in adult postoperative ICU after cardiothoracic surgery till peripheral temperature is increased  0 min, 15 min, 30 min, 60 min, 120 min 
 
Secondary Outcome  
Outcome  TimePoints 
To compare change in plethysmographic perfusion index with parameters involving change in VTI, CVP, IVC diameter for detecting fluid responsiveness.
In fluid responders, whether any change in PPI can predict the fluid requirement 
0 min, 15 min, 30 min, 60 min, 120 min 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
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)   10/03/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  
Hemodynamic management post-cardiac surgery is crucial for optimal patient outcomes. Hemodynamic instability is common, exacerbated by hypovolemia and vasodilation. The goal is to maintain perfusion and oxygen delivery, targeting variables like heart rate, mean arterial pressure, and central venous pressure. Fluid resuscitation is vital for early instability, addressing blood loss, vascular capacitance, fluid losses, and increased preload requirements. Assessing preload dynamics is challenging, with static pressures poorly predicting fluid responsiveness. Dynamic approaches like pulse pressure and stroke volume variation have limitations.

Plethysmographic perfusion index (PI) offers a non-invasive method to assess fluid responsiveness. PI, derived from pulsatile and non-pulsatile light absorption, reflects arterial volume changes during the cardiac cycle. PI varies with changes in vascular tone, making it a potential indicator of fluid responsiveness. Studies show correlations with vascular tone changes induced by anesthesia and vasopressors.

Our study aims to validate PI for detecting fluid responsiveness in postoperative cardiac patients during warming until peripheral temperature reaches 30 C. We’ll also explore the correlation between PI changes and fluid requirements. If proven reliable, PI could revolutionize non-invasive fluid assessment, aiding cardiac care providers in optimal postoperative fluid resuscitation.


Hypothesis:

There is correlation between change in plethysmographic perfusion index and postoperative fluid responsiveness in immediate postoperative period in patients who underwent cardiothoracic surgery.
 
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