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CTRI Number  CTRI/2024/01/061105 [Registered on: 04/01/2024] Trial Registered Prospectively
Last Modified On: 01/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective 
Study Design  Other 
Public Title of Study   A study done to evaluate the usefulness of changes in a non- invasive parameter called End Tidal Carbon Dioxide after giving fluid infusion to neurosurgery patients to predict whether they will respond with an increase in cardiac output 
Scientific Title of Study   A prospective observational study to evaluate the utility of changes in end tidal carbon dioxide to assess fluid responsiveness after volume expansion in patients undergoing neurosurgery in supine position 
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 Anjali R Hegde 
Designation  Postgraduate Medical Student 
Affiliation  Bangalore Medical College and Research Institute 
Address  Department of Anaesthesiology, Bangalore Medical College and Research Institute, KR Market, Bangalore, Karnataka

Bangalore
KARNATAKA
560002
India 
Phone  9986994287  
Fax    
Email  anjurh14@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Surekha C 
Designation  Assistant Professor 
Affiliation  Bangalore Medical College and Research Institute 
Address  Department of Anaesthesiology, Bangalore Medical College and Research Institute, KR Market, Bangalore, Karnataka

Bangalore
KARNATAKA
560002
India 
Phone  9845489724  
Fax    
Email  suri.c13@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Surekha C 
Designation  Assistant Professor 
Affiliation  Bangalore Medical College and Research Institute 
Address  Department of Anaesthesiology, Bangalore Medical College and Research Institute, KR Market, Bangalore, Karnataka

Bangalore
KARNATAKA
560002
India 
Phone  9845489724  
Fax    
Email  suri.c13@gmail.com  
 
Source of Monetary or Material Support  
Bangalore Medical College and Research Institute,K R Market, Bangalore - 560002, Karnataka  
 
Primary Sponsor  
Name  Dr. Anjali R Hegde 
Address  Department of Anaesthesiology, Bangalore Medical College and Research Institute, KR Market, Bangalore, Karnataka 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Surekha C  Pradhan Mantri Swasthya Suraksha Yojana Hospital   Department of Anesthesiology, , Bangalore Medical College and Research Institute, K R Market, Bangalore 560002
Bangalore
KARNATAKA 		 9845489724

suri.c13@gmail.com 
Dr Surekha C  Victoria Hospital   Department of Anesthesiology, , Bangalore Medical College and Research Institute, K R Market, Bangalore 560002
Bangalore
KARNATAKA 		 9845489724

suri.c13@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Ethics Committee of Bangalore Medical College and Research Institute - PMSSY Hospital  Approved 
Ethics Committee of Bangalore Medical College and Research Institute - Victoria Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G968||Other specified disorders of central nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1.ASA I & II patients
2.Patients aged above 18years
3.Patients undergoing neurosurgery in supine position under general anaesthesia 
 
ExclusionCriteria 
Details  1. Patients with cardiac arrhythmias, valvular heart diseases or left or right heart failure
2. Patients with chronic obstructive pulmonary disease with a MMRC Dyspnea Scale 3 or more
3. Patients with intrathoracic lesions
4. Pregnant women
5. Patients on vasoactive drugs 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in End tidal carbon dioxide after volume expansion to predict fluid responsiveness defined as fall in Pleth Variability Index to less than 14 percent and increase in SBP by 10 mm Hg or more  Baseline, 1 min, 3 min, 5 mins and 10 mins after completion of infusion. 
 
Secondary Outcome  
Outcome  TimePoints 
Pleth Variability Index and Pulse Pressure Variation   Baseline, 1 min, 3 min, 5 mins and 10 mins after completion of infusion. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   15/01/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   This is a prospective observational study to evaluate the utility of change in end tidal carbon dioxide after volume expansion using 4 ml per kg of crystalloid solution in predicting fluid responsiveness in patients undergoing neurosurgery in supine position under general anaesthesia. Optimum intra-operative fluid management is essential in neurosurgery patients to balance risk of cerebral ischemia versus cerebral edema. Fluid responsiveness can be used to identify patients on the ascending portion of Frank – Starling curve, who can increase cardiac output in response to volume expansion. EtCO2 depends on three variables – Tissue CO2 production, pulmonary blood flow (i.e. cardiac output), and alveolar ventilation. Hence when CO2 production and ventilatory  parameters are kept constant, EtCO2 may accurately indicate cardiac output. With this study we plan to evaluate usefulness of EtCO2, a simple, inexpensive, non -invasive parameter, to predict fluid responsiveness in operation theatre.



 
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