| CTRI Number |
CTRI/2024/08/072359 [Registered on: 12/08/2024] Trial Registered Prospectively |
| Last Modified On: |
17/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of correlation between handgrip strength and RCRI scores, along with laboratory investigations, for preoperative frailty evaluation in patients undergoing lower limb orthopedic surgeries.
|
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Scientific Title of Study
|
An Observational Prospective Study To Evaluate The Correlation Of Handgrip Strength With RCRI and Lab Investigations For Preoperative Assessment Of Fraility In Patients Undergoing Lower Limb Orthopaedic Surgeries |
| 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 Athira CN |
| Designation |
Resident |
| Affiliation |
Bharati Vidyapeeth (DTU) University, Pune |
| Address |
Bharati Hospital and research centre, Department Of Anaesthesia, Pune-411043
Bharati Hospital and research centre, Department Of Anaesthesia, 3rd floor, Pune-Satara Road, Pune-411043
Pune
MAHARASHTRA
411043
India |
| Phone |
7511111158 |
| Fax |
|
| Email |
drathiracn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarita Swami |
| Designation |
professor |
| Affiliation |
Bharati Vidyapeeth (DTU) University, Pune |
| Address |
Bharati Hospital and research centre, Department Of Anaesthesia,Pune-Satara Road, Pune-411043
Bharati Hospital and research centre, Department Of Anaesthesia, 3rd floor, Pune-Satara Road, Pune-411043
Pune
MAHARASHTRA
411043
India |
| Phone |
9822846369 |
| Fax |
|
| Email |
drswamisarita@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Athira CN |
| Designation |
Resident |
| Affiliation |
Bharati Vidyapeeth (DTU) University, Pune |
| Address |
Bharati Hospital and research centre, Department Of Anaesthesia, Pune-Satara Road, Pune-411043
Bharati Hospital and research centre, Department Of Anaesthesia, 3rd floor, Pune-Satara Road, Pune-411043
Pune
MAHARASHTRA
411043
India |
| Phone |
7511111158 |
| Fax |
|
| Email |
drathiracn@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Hospital and Research Centre, Dhankanwadi, Katraj, Pune-411043 |
|
|
Primary Sponsor
|
| Name |
Bharati Hospital and Research Centre |
| Address |
Bharati Hospital and Research Centre, Pune-Satara Road, Pune 411043 |
| 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 Athira CN |
Bharati hospital and research centre |
Bharti Hospital and Research centre, Critical Care Department, superspeciality building, 2nd floor, PuneSatara road, Pune 411043 Pune MAHARASHTRA Pune
Pune
MAHARASHTRA |
7511111158
drathiracn@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth Deemed to be University Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.patients of the age above 65 of either sex
2.ASA I / II / III patients
3.patients undergoing elective lower limb Orthopedic surgeries under central neuraxial blockade
|
|
| ExclusionCriteria |
| Details |
1)Patients who are not willing to take part in the study.
2)Patients with pathological defects such as paralysis, arthritis, and trauma that obviously impair grip strength will be excluded
3)Patients who are unable to comprehend the commands or use the dynamometer freely
4)Patients with coagulopathy, spinal deformities and other contraindications to central neuraxial blockade
5)Patients posted for emergency Orthopedic surgeries.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
PRIMARY OBJECTIVE
-To assess the Handgrip Strength in the Preoperative period
-To assess Intra Operative and Post-Operative outcomes like blood loss, Inotrope requirement, post operative ICU stay and length of hospital stay.
-To Compare the Grades of Hand Grip Strength with the Intra and Post Operative Outcomes.
|
the patient will be assessed in the preoperative period, intraoperative period and the immediate postoperative period.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
SECONDARY OBJECTIVE
To Correlate Handgrip Strength with other Frailty Measurements(investigations) like-
- CRP
- Serum Albumin
- Revised Cardiac Risk Index (RCRI)
|
BASELINE |
|
|
Target Sample Size
|
Total Sample Size="95"
Sample Size from India="95"
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)
|
20/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/08/2024 |
| 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)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Aging is a global phenomenon and the elderly adults carry an increasing burden of chronic illnesses which affect their overall health and well-being. Fraility is identified by decreased reserves in multiple organ systems. Fraility has been known to be associated with postoperative adverse events and Longer Hospital Length of Stay (LOS). Identifying frail patients has always been an important part of improving post operative outcome. Assessing the skeletal muscle reserves has been an integral part of predicting the nutritional status of the patient and also the post-operative outcome. Estimates of skeletal protein and plasma albumin concentrations is useful in detecting malnutrition. Hypoalbuminemia accurately reflects malnutrition and a low preoperative albumin concentration was associated with high post-operative complications. Researchers have defined appreciable protein depletion as existing when arm muscle circumference is below 85% of the standard, hand grip strength is below 85% of normal, or plasma albumin concentration below 35 g/l. Handgrip dynamometry is a sensitive screening test to detect preoperative malnutrition and predict postoperative complications. Hand grip strength (HGS) is used to diagnose both sarcopenia and frailty. Low grip strength is consistently associated with a greater likelihood of premature mortality, development of disability and an increased risk of complications. the gold standard of risk stratification in pre-operative settings include the use of the Revised Cardiac Risk Index (RCRI). Previous studies have concluded that a weaker Hand grip strength was significantly associated with lower levels of serum albumin, higher RCRI score, and a longer hospital LOS in patients undergoing major surgery. |