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CTRI Number  CTRI/2024/05/067390 [Registered on: 15/05/2024] Trial Registered Prospectively
Last Modified On: 15/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   A comparison of two different scoring systems to see which one is better at predicting the possibility of heart related complications after skull base surgery.  
Scientific Title of Study   A retrospective cohort for validation of the ACS-NSQIP scoring system with comparison of RCRI scoring system to determine accuracy of perioperative outcome prediction of patients with cardiac risk factors who have undergone elective Base of skull surgeries in a tertiary care center in South India 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rohan Jacob Titus 
Designation  PG registrar 
Affiliation  Christian Medical College, Vellore 
Address  Dept. of Anaesthesia, Christian Medical College and Hospital, Vellore.

Vellore
TAMIL NADU
632004
India 
Phone  9597040994  
Fax    
Email  rohan.j.titus@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sathish Kumar Dharma 
Designation  Professor 
Affiliation  Christian Medical College, Vellore 
Address  Dept. of Anaesthesia, Christian Medical College and Hospital, Vellore.

Vellore
TAMIL NADU
632004
India 
Phone  6369379259  
Fax    
Email  drsathish78@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Rohan Jacob Titus 
Designation  PG registrar 
Affiliation  Christian Medical College, Vellore 
Address  Dept. of Anaesthesia, Christian Medical College and Hospital, Vellore.

Vellore
TAMIL NADU
632004
India 
Phone  9597040994  
Fax    
Email  rohan.j.titus@gmail.com  
 
Source of Monetary or Material Support  
Fluid research grant, Christian Medical College, Vellore, Tamilnadu, India -632004 
 
Primary Sponsor  
Name  Rohan Jacob Titus 
Address  Dept. of Anaesthesia, Christian Medical College and Hospital, Vellore, Tamilnadu, India - 632004 
Type of Sponsor  Other [] 
 
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 Rohan Jacob Titus  Christian Medical College and hospital  Dept. of Anaesthesia
Vellore
TAMIL NADU 		 9597040994

rohan.j.titus@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board, Christian Medical College Association, Ida Scudder Road, Vellore.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Q273||Arteriovenous malformation (peripheral), (2) ICD-10 Condition: M01X||Direct infection of joint in infectious and parasitic diseases classified elsewhere, (3) ICD-10 Condition: C800||Disseminated malignant neoplasm, unspecified, (4) ICD-10 Condition: C709||Malignant neoplasm of meninges, unspecified, (5) ICD-10 Condition: B998||Other infectious disease, (6) ICD-10 Condition: Q048||Other specified congenital malformations of brain,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All patients in my cohort that have undergone base of skull surgery and have an RCRI score more than 1 
 
ExclusionCriteria 
Details  All patients in my cohort that have an RCRI score less than 1. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Percentage risk of MACE i.e major adverse cardiac events, in the perioperative period in both the RCRI scoring system and the ACS-NSQIP scoring system  Prior to surgery, at 30 days post-operatively. 
 
Secondary Outcome  
Outcome  TimePoints 
not applicable  not applicable 
 
Target Sample Size   Total Sample Size="439"
Sample Size from India="439" 
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)   03/06/2024 
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="0"
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   So far, the modified Revised Cardiac Risk Index (RCRI) has been the go-to scoring system for letting surgeons, anaesthetists and patients know the risk of MACE (major adverse cardiac events) in the perioperative period. It however is limited as there are so many other significant perioperative events that may account for patient morbidity and mortality which it cannot calculate for.
The ACS-NSQIP (american college of surgeons - national surgical quality index programme) scoring system can give a risk percentage and account for both MACE as well as other perioperative events, however it is to be validated for specific types of surgeries induvidually. 
My study intends to assess whether the ACS-NSQIP score is as good as the modified RCRI score in predicting MACE for patients with cardiac risk factors undergoing non-cardiac surgeries, specifically base of skull surgeries. My study is designed as a retrospective cohort and hence will rapidly show the comparibility between the two scores, as a prospective study will mandate a minimum 30 day waiting period. It will also allow for risk assessment for other potential perioperative events by the ACS-NSQIP scoring system.
 
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