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CTRI Number  CTRI/2024/04/065304 [Registered on: 05/04/2024] Trial Registered Prospectively
Last Modified On: 22/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Comparison between frailty score and anaesthesia risk index to predict possibility of complications after brain surgery. 
Scientific Title of Study   Comparison of Fried’s Frailty Phenotype and American Society of Anaesthesiologists (ASA) classification as predictors of postoperative complications in elective craniotomies - A prospective single center 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 Joseph Nascimento Monteiro 
Designation  Programme Director Neuroanaesthesis 
Affiliation  P.D.Hinduja Hospital and Medical Research Center 
Address  Division of Neuroanaesthesia Department of Anaesthesiology P.D.Hinduja Hospital and Medical Research Center Veer Savarkar marg Mahim, Mumbai

Mumbai
MAHARASHTRA
400016
India 
Phone  0919821158949  
Fax    
Email  monteiro04@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Nimisha Thakur 
Designation  DrNB Neuroanaesthesia Senior Resident 
Affiliation  P.D.Hinduja Hospital and Medical Research Center 
Address  Division of Neuroanaesthesia Department of Anaesthesiology P.D.Hinduja Hospital and Medical Research Center Veer Savarkar marg Mahim, Mumbai

Mumbai
MAHARASHTRA
400016
India 
Phone  0918454082998  
Fax    
Email  nimisha4395@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Nimisha Thakur 
Designation  DrNB Neuroanaesthesia Senior Resident 
Affiliation  P.D.Hinduja Hospital and Medical Research Center 
Address  Division of Neuroanaesthesia Department of Anaesthesiology P.D.Hinduja Hospital and Medical Research Center Veer Savarkar marg Mahim, Mumbai

Mumbai
MAHARASHTRA
400016
India 
Phone  0918454082998  
Fax    
Email  nimisha4395@gmail.com  
 
Source of Monetary or Material Support  
P.D.Hinduja Hospital and Medical Research Centre, Mahim, Mumbai 
 
Primary Sponsor  
Name  P.D.Hinduja Hospital and Medical Research Center 
Address  Veer Savarkar marg Mahim Mumbai 400016  
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 Nimisha Thakur  P.D.Hinduja Hospital and Medical Research Center  Division of Neuroanaesthesia, Department of Anaesthesia Veer Savarkar marg Mahim Mumbai 400016
Mumbai
MAHARASHTRA 
8454082998

nimisha4395@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
P.D.Hinduja Hospital and Medical Research Center  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D497||Neoplasm of unspecified behavior of endocrine glands and other parts of nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All consenting patients above the age of 50 years undergoing elective Craniotomy 
 
ExclusionCriteria 
Details  Patients undergoing emergency neurosurgical procedure.

Patients with ASA classes V (moribund patients) and VI (Brain dead patients)
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess length of postoperative ICU stay.  From day of preoperative assessment to discharge from ICU. 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcomes measured will be non-home discharge, readmission, surgical or medical complications and mortality.  From date of surgery to 1 month post surgery. 
 
Target Sample Size   Total Sample Size="124"
Sample Size from India="124" 
Final Enrollment numbers achieved (Total)= "126"
Final Enrollment numbers achieved (India)="126" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/06/2024 
Date of Study Completion (India) 21/01/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 21/01/2025 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - None of the above

  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 [nimisha4395@gmail.com].

  6. For how long will this data be available start date provided 28-12-2026 and end date provided 28-12-2029?
    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)  

As a perioperative physician, a crucial task for every anaesthesiologist is to assess the individualized risk and expected outcome for any patient undergoing surgery. Along with the traditional stack of various risk assessment scores, a recently famous parameter is the frailty index. While more and more studies are being done to assess frailty as a measure of risk stratification, there is still a paucity of literature in this topic with respect to neurosurgical cases involving craniotomy, especially in south-Asian countries.

Frailty is defined as a clinical condition characterized by excessive vulnerability of an individual to endogenous and exogenous stressors. One such exogenous stressor is a major surgical procedure like craniotomy. Frailty can be expected to have an effect on the outcome and thus help individualize perioperative patient counselling and management including incentive spirometry, physiotherapy initiation, nutrition supplementation and social or occupational rehabilitation. For assessing outcome of neurosurgical patients, several tools are in place e.g., ASA physical status, NSQIP calculation, Lee’s Revised cardiac risk index and a few more. Frailty has been validated as a score of risk assessment in general surgical, urologic and cardiac patients.

While the usual scores of assessment of frailty as devised by the national surgical quality improvement program (NSQIP), named modified frailty indices 5 and 11 (mFI-11 and mFI-5) have proven validation, they focus more on the comorbidity status of the patient, whether controlled or uncontrolled, which is essentially similar to the ASA classification. mFI-5 is calculated by presence or absence of 5 co-morbidities, namely Congestive heart failure, diabetes mellitus, Chronic obstructive pulmonary disease or pneumonia, partially or totally dependent health status and hypertension requiring medication. mFI-11 is a 11-score system of assessment, which, along with the 5 factors forming mFI5, involves additional factors including history of Myocardial infarction, percutaneous coronary intervention or coronary artery bypass grafting, peripheral vascular disease, altered sensorium, transient ischemic attacks or cerebrovascular accidents, cerebrovascular accidents with residual neuro-deficit. Fried’s frailty phenotype is a newer index which has been validated as a predictor of postoperative outcome using data from cardiovascular health study and is expected to be equally helpful, and includes measures of current functional status of the patient regardless of their preexisting comorbidities. It has been studied and validated in nonsurgical as well as certain surgical groups including those undergoing urological and cardiothoracic procedures, although less so in craniotomy cases. The effect of frailty on operative outcome has also been studied in spine surgery cases. However there is still a paucity of literature with respect to using this index in craniotomy cases, especially in south-Asian population.

 This study seeks to determine comparable reliabilities of Fried’s Frailty Phenotype (FFP) and American Society of Anaesthesiologists (ASA) classification in predicting postoperative outcome in elective craniotomies. It is an attempt to add to the preexisting literature and determine the predictive value of the already established score in the less studied patient population.

 
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