| 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
|
|
|
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
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - None of the above
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [nimisha4395@gmail.com].
- 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.
- 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. |