| CTRI Number |
CTRI/2019/02/017668 [Registered on: 14/02/2019] Trial Registered Prospectively |
| Last Modified On: |
11/02/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To predict 30-day in hospital mortality and morbidity using preoperative hand grip strength and comparing it with existing Revised cardiac risk index and Modified Frailty Index |
|
Scientific Title of Study
|
Comparison of preoperative Handgrip Strength with Revised Cardiac Risk Index and Modified Frailty Index for predicting 30-day in hospital mortality and morbidity |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kompal Jain |
| Designation |
Senior Resident |
| Affiliation |
Government Medical College and Hospital |
| Address |
Department of Anaesthesia and Intensive Care,
Government Medical College and Hospital,Sector - 32, Chandigarh
Chandigarh
CHANDIGARH
160032
India |
| Phone |
|
| Fax |
|
| Email |
kompaljain3.kj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Richa Saroa |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College and Hospital |
| Address |
Department of Anaesthesia and Intensive Care,
Government Medical College and Hospital,Sector - 32, Chandigarh
Chandigarh
CHANDIGARH
160032
India |
| Phone |
|
| Fax |
|
| Email |
richajayant@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjeev Palta |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital |
| Address |
Department of Anaesthesia and Intensive Care,
Government Medical College and Hospital,Sector - 32, Chandigarh
Chandigarh
CHANDIGARH
160032
India |
| Phone |
|
| Fax |
|
| Email |
sanjeev_palta@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Hospital, sec 32, Chandigarh-160032 |
|
|
Primary Sponsor
|
| Name |
Dr sanjeev Palta |
| Address |
Professor,Government Medical College and Hospital, sec 32, Chandigarh-160032 |
| 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 sanjeev Palta |
Government Medical College and Hospital |
GMCH,sec 32, Chandigarh 160032
Chandigarh
CHANDIGARH |
9646121523
sanjeev_palta@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(GMCH, Chandigarh) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K66||Other disorders of peritoneum, (2) ICD-10 Condition: M16||Osteoarthritis of hip, (3) ICD-10 Condition: M17||Osteoarthritis of knee, (4) ICD-10 Condition: J96-J99||Other diseases of the respiratory system, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anesthesiologists (ASA) physical status I - III
Age > 40 years
BMI – 18-40 kg/m2 of either sex
Scheduled to undergo elective/emergency non-cardiac thoracoabdominal or orthopaedic surgery
|
|
| ExclusionCriteria |
| Details |
Patient refusal to give informed consent
Patients who are unable to comprehend the commands Patients ho are unable to use the dynamometer freely
Haemodynamically unstable patients
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of preoperative HGS with RCRI(Revised Cardiac Risk Index) and MFI(Modified Frailty Index) to find out which one is a better predictor of 30-day post-operative mortality and morbidity. |
Comparison of preoperative HGS with RCRI and MFI to find out which one is a better predictor of 30-day post-operative mortality and morbidity. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Co-relation of preoperative HGS with 30-day outcome in terms of post-operative complications within 7 days, need for ICU admission/ventilatory support, length of hospital stay, in-hospital morbidity/mortality and METs scale pre-operatively and on post op day 7, 15 & 30. |
Preoperatively and Postoperative day 7, 15 and 30 |
|
|
Target Sample Size
|
Total Sample Size="340"
Sample Size from India="340"
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)
|
20/02/2019 |
| 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="1"
Months="1"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Preoperative evaluation aims to identify the patients with high risk for postoperative mortality and morbidity. Different tools and imaging tests have been used to estimate the patient’s risk of perioperative cardiac complications posted for major non cardiac surgeries like Lee index, Revised Cardiac Risk Index (RCRI), Modified Frailty Index (MFI) and walking based test. Different imaging tests adds to cost and delays the surgical procedure. Frailty is a multi-dimensional syndrome associated with perioperative mortality and morbidity and reflects inactivity, low muscle mass, and reduced energy.It consists of four domains which includes physical, psychological, cognitive and social frailty.One of the criteria of physical frailty includes strength. The progressive and generalized decrease in amount and strength of skeletal muscle is known as sacropenia.Sacropenia has been identified as one of the risk factors associated with poor perioperative outcome and increase hospital stay in surgical patients undergoing resection of either gastrointestinal, bladder, endometrial, hepatocellular, head or neck malignancy and liver transplant surgery. Hand grip strength is one of the predictors of muscle strength and mass. Handgrip strength (HGS) measured using handgrip dynamometry is a simple, inexpensive, quick and easily accessible tool to detect sacropenia and physical frailty. Therefore, integrating handgrip strength alongside clinical risk factors may further improve pre-operative risk stratification in patients undergoing thoracoabdominal or orthopaedic surgery. In doing so, handgrip assessment may aid in the allocation of surgical resources, may decrease expense by preventing patients from receiving costly and potentially unnecessary procedures and imaging tests. Hence, we proposed to compare preoperative hand grip strength with Revised Cardiac Risk Score and modified Frailty Score for predicting postoperative mortality and morbidity and to correlate preoperative HGS using hand grip dynamometry with 30-day in hospital mortality and morbidity in patients undergoing thoracoabdominal or orthopaedic surgeries under general or regional anaesthesia.
|