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CTRI Number  CTRI/2024/07/069986 [Registered on: 04/07/2024] Trial Registered Prospectively
Last Modified On: 03/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Correlational observational study to assess the generalised muscle weakness in old age patients coming for elective surgeries by using Dynamometer and Ultrasound guided muscle mass assessment. 
Scientific Title of Study   Correlation between clinical assessment of frailty and preoperative point of care USG assessment of muscle mass in the elderly surgical population undergoing elective surgery - a Prospective 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 Franklin Vetha Prabu S 
Designation  Post Graduate Registrar 
Affiliation  Christian Medical College 
Address  Dr . Franklin Vetha Prabu. S, Department of Anaesthesiology, Christian Medical College, Vellore- 632004

Vellore
TAMIL NADU
632004
India 
Phone  9790462211  
Fax    
Email  liofrank91@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Georgene Singh 
Designation  Professor 
Affiliation  Christian Medical College 
Address  Dr. Georgene singh Professor, Department of Anesthesiology, Christian Medical College

Vellore
TAMIL NADU
632004
India 
Phone  9443292504  
Fax    
Email  georgenesingh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Georgene Singh 
Designation  Professor 
Affiliation  Christian Medical College 
Address  Dr. Georgene singh Professor, Department of Anesthesiology, Christian Medical College

Vellore
TAMIL NADU
632004
India 
Phone  9443292504  
Fax    
Email  georgenesingh@gmail.com  
 
Source of Monetary or Material Support  
Fluid Research Grant, Christian Medical college, Vellore- 632004, Tamilnadu, India 
 
Primary Sponsor  
Name  Franklin Vetha Prabu S 
Address  Dr . Franklin Vetha Prabu. S, Department of Anaesthesiology, Christian Medical College, Vellore-632004,Tamil Nadu, India.  
Type of Sponsor  Other [Self] 
 
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 Franklin Vetha Prabu S  Christian Medical College  Department of Anaesthesiology, Vellore, Tamil Nadu
Vellore
TAMIL NADU 
9790462211

liofrank91@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board and Ethics Committee of CMC Vellore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M625||Muscle wasting and atrophy, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1.ASA Grade 1 2 and 3
2.Patients undergoing elective urological procedures requiring anaesthesia.
 
 
ExclusionCriteria 
Details  1. Age <60 years
2. Patients refusing to participate in the study.
3. Emergency procedures.


 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To assess the correlation between clinical assessment of frailty and POCUS measurement of Quadriceps Depth, Rectus femoris cross sectional area and circumference.   20 Minutes 
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess the correlation between the various components of the frailty score and their correlation with the POCUS parameters


2. To determine an USG derived cut-off for Quadriceps Depth, Rectus femoris cross sectional area and circumference to predict frailty in the Indian population.

 
20 Minutes 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   15/07/2024 
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="8"
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  

Frailty is the decline in physical and cognitive reserves leading to increased vulnerability to stressors such as surgery or disease states. The frail phenotype is associated with a decreased status in mobility, muscle mass, nutritional status, strength, endurance and is associated with post-surgical adverse outcomes and increased risk of mortality as compared to their fit or resilient counterparts.

Many frailty assessment tools have been created to help us identify these at-risk patients. The  Clinical Frailty Scale(CFS) utilizes 9 components to assess frailty and  focuses on items that can be readily observed without specialist training, including mobility,  balance and use of walking aids and the abilities to eat, dress, shop, cook, and bank. However, it is only a subjective assessment of frailty.

The Fried frailty (1) index which is a more objective measurement, characterizes frailty in five different domains (weight loss, exhaustion, weakness, slowness, and physical activity levels). Although extensively validated the assessment may be too time-consuming to perform in a preanaesthetic setting and was not created to risk-stratify preoperative patients.

In the perioperative setting, a frailty tool that can be applied when a patient is not able to walk due to an acute or chronic disease process or unable to provide a comprehensive medical history due to altered mental status is necessary. Use of conventional scales can be challenging.

Sarcopenia, or skeletal muscle loss which is a biologic and functional marker of frailty has been objectively quantified by using computed tomography (CT) to identify frailty in their surgical populations (2). However, computed tomography is expensive, resource-intensive and exposes patients to radiation. Therefore, unless the patient needs a preoperative CT scan as part of standard of care for their diagnostic work-up, it is not an optimal diagnostic tool of frailty.

Recently, Point of care ultrasound (POCUS) has been used to discriminate between frail and non-frail patients before surgery and in Intensive care units by measuring Quadriceps, rectus femoris, Psoas depth , thickness (3)  and cross sectional area .

We hypothesize that Point of Care Ultrasound (POCUS) measurement of Quadriceps Depth, Rectus Femoris cross-sectional area and circumference will correlate well with clinical assessment of frailty.

 
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