| 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
|
|
|
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
|
|
|
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. |