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CTRI Number  CTRI/2024/07/071677 [Registered on: 31/07/2024] Trial Registered Prospectively
Last Modified On: 18/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Relation Oxygen Saturation Variation and decrease blood pressure.  
Scientific Title of Study   To determine the correlation co efficient between plethysmographic variability index and pulse pressure variation as a marker for intravascular volume status in non-laproscopic abdominal surgery. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vikram Singh Rathore  
Designation  Associate Prof 
Affiliation  Uttar Pradesh University Medical Sciences 
Address  Department of Anaesthesiology and Critical Care Uttar pradesh university of Medical sciences Etawah 206130

Etawah
UTTAR PRADESH
206130
India 
Phone  918826719977  
Fax    
Email  vikram2012.mmc@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Harsha D 
Designation  Consultant 
Affiliation  medipulse hospital 
Address  Department of Anaesthesiology and Critical Care Medipusle Hospital Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone    
Fax    
Email  harshadoddaramegowda@gmail.com  
 
Details of Contact Person
Public Query  
Name  dr vikram Singh rathore 
Designation  Associate Prof 
Affiliation  Uttar Pradesh University Medical Sciences 
Address  DDepartment of Anaesthesiology and Critical Care Uttar pradesh university of Medical sciences Etawah 206130

Etawah
UTTAR PRADESH
206130
India 
Phone  8826719977  
Fax    
Email  vikram2012.mmc@gmail.com  
 
Source of Monetary or Material Support  
Base Hospital Delhi Cantt.Department of Anaesthesiology and critical care Delhi cantt.110010 India 
 
Primary Sponsor  
Name  Base Hospital Delhi Cantt Department of Anaesthesiology 
Address  Base Hospital Delhi Cantt.Department of Anaesthesiology and critical care Delhi cantt.110010 India 
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 
vikram singh rathore  Base hospital delhi cantt  Base Hospital Delhi Cantt.Department of Anaesthesiology and critical care Delhi cantt.110010 India
Central
DELHI 		 918826719977

vikram2012.mmc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethic committee Base hospital delhi cantt  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K353||Acute appendicitis with localizedperitonitis, (2) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patents in ASA Class I-II
Age 18 to 60 years of age
All patients undergoing major surgery require invasive arterial pressure monitoring.
 
 
ExclusionCriteria 
Details  pregnancy
ccf 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the correlation coefficient between Plethysmographic Variability Index (PVI) and Pulse Pressure Variation (PPV) as a marker for intravascular volume status in non-laparoscopic abdominal surgery  At 5 min before fluid bolus, and then every 05 min interval after fluid bolus till 30 min 
 
Secondary Outcome  
Outcome  TimePoints 
Hemodynamic changes and disharge  2days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "55"
Final Enrollment numbers achieved (India)="55" 
Phase of Trial   N/A 
Date of First Enrollment (India)   09/08/2024 
Date of Study Completion (India) 17/10/2024 
Date of First Enrollment (Global)  09/08/2024 
Date of Study Completion (Global) 17/10/2024 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [vikram2012.mmc@gmail.com].

  6. For how long will this data be available start date provided 13-08-2016 and end date provided 13-08-2018?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  		 Respected Madam/sir,
It is the cross-sectional observational study conducted after ethical approval.
here for publication of our finding ,journal need the ctri no.
humble request for your kind approval
regards 
 
 
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