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CTRI Number  CTRI/2019/11/022056 [Registered on: 19/11/2019] Trial Registered Prospectively
Last Modified On: 20/02/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   Outcome of old age patients coming for surgery 
Scientific Title of Study   Predicting increased length of stay and adverse outcome in Indian Geriatric patients coming for surgery: A prospective case control study.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Yudhyavir Singh 
Designation  Assistant Professor 
Affiliation  AIIMS, New Delhi 
Address  Room no- 5011, AB8, Deptt of Anaesthesia, Ansari Nagar, AIIMS

South
DELHI
110029
India 
Phone    
Fax    
Email  yudhyavir@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Yudhyavir Singh 
Designation  Assistant Professor 
Affiliation  AIIMS, New Delhi 
Address  Room no- 5011, AB8, Deptt of Anaesthesia, Ansari Nagar, AIIMS


DELHI
110029
India 
Phone    
Fax    
Email  yudhyavir@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Yudhyavir Singh 
Designation  Assistant Professor 
Affiliation  AIIMS, New Delhi 
Address  Room no- 5011, AB8, Deptt of Anaesthesia, Ansari Nagar, AIIMS


DELHI
110029
India 
Phone    
Fax    
Email  yudhyavir@gmail.com  
 
Source of Monetary or Material Support  
None 
 
Primary Sponsor  
Name  AIIMS Hospital 
Address  Deptt of Anaesthesia, AIIMS, New Delhi 
Type of Sponsor  Research institution and hospital 
 
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 
Yudhyavir Singh  AIIMS  ROOM NO- 5011, DEPTT OF ANAESTHESIA, ANSARI NAGAR,AIIMS
South
DELHI 
09811140057

yudhyavir@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R99||Ill-defined and unknown cause of mortality,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Blood Investigations will be collected when patients will be admitted. Blood will be taken only once for various investigations 
Intervention  Nil  Blood investigations will be collected when patients will be admitted. Will be taken only once after admission 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Age > 60 years.
2. More than equal to 3 Prescribed medications
3. Impaired mobility
 
 
ExclusionCriteria 
Details  1. Patient who died within 48 hours.
2. Length of hospital stay less than 3 days
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess admission frailty and its association with increased length of hospital stay.  At the time of admission and at the time of discharge/death 
 
Secondary Outcome  
Outcome  TimePoints 
To asses whether frailty is associated with in hospital complications and with adverse discharge disposition.  1 year 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   29/11/2019 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

According to Population Census 2011, there are nearly 104 million elderly persons (aged 60 years or above) in India; 53 million females and 51 million males. A report released by the United Nations Population Fund and Help Age India suggests that the number of elderly persons is expected to grow to 173 million by 2026 and to 300 million by 2050.

Older patients have worse outcomes than younger patients, with higher mortality, higher complications rates, adverse discharge outcomes and longer hospital stay. Development of adverse outcomes in the geriatric population cannot be explained solely by advanced age. Concomitantly, surgical practice patterns have evolved to prioritize the maximization of disease management over the potential risks of surgery in the elderly. The large and increasing proportion of surgical procedures performed on this aging population of patients has made it incumbent on the anaesthetic and surgical community to improve risk stratification. Therefore, we continue to seek additional factors that may predict a patient’s perioperative risk for major adverse events.

Frailty, in particular, has become an area of increased interest. Frailty is a multidimensional state of loss of physiologic reserves including energy, physical ability, cognition, and health that gives rise to vulnerability to poor health outcomes due to a decreased ability to withstand physiologic stress. But, there is no universal definition of frailty because assessments of frailty range from the very simple (number of outpatient medications) to the relatively complex (scored clock-drawing test).6There is consensus that frailty, as measured by any number of these metrics, is associated with adverse perioperative outcomes including major morbidity, mortality, and increased length of stay.Therefore we planned a study to assess the adverse outcomes in geriatric population  by assessing the frailty.

Patients will be assessed and screened for frailty at the time of pre-anaesthetic check-up, prior to the surgery. Frailty will be assessed by the CFS and F1 LAB scores. Assessors may not be present daily and data will be collected on days the patient will be operated. Some of patients who will get re-do for the same surgery, will also be considered.  A small number of patients may be operated for > 1 procedure after assessment, the surgery with higher complexities will be used.  The Clinical frailty scale and the F1 LAB are defined below.

 

Clinical Frailty Scale:

The geriatrician determines the CFS score during the initial consultation, through history obtained from the patient, family, and/or other health care providers about comorbidities, energy level, and functional status. CFS scores of patients at the included in the study were abstracted from the comprehensive geriatric assessment. If the value was not available in the consultation note, a manual chart review was conducted to assign the score. Two raters independently determined the CFS score of each patient, and a third study author adjudicated any remaining conflicts after reconciliation of the scores. The CFS scores were stratified into 3 groups based on the CFS validation study13: 1 to 3 were “not frail,” 4 and 5 were “at risk to mildly frail,” and 6 and 7 were “frail.” The “at risk to mildly frail” group was separated into “apparently vulnerable” (CFS 4) and “mildly frail” (CFS 5) in the descriptive statistics and unadjusted analyses. (Appendix1)

 

Laboratory Frailty Index

The 23-item laboratory Frailty Index (FI-lab) was calculated based on first available values within 48 hours of presentation to hospital. The FI-lab was modified from the original version described by Howlett and colleagues14 to accommodate laboratory values readily available for a trauma patient. The venereal disease research laboratory test, T4, folate, and RBC folate were removed because very few patients had these parameters measured. These 4 variables were replaced by troponin, international normalized ratio, venous lactate, and oxygen saturation because they are commonly measured in the setting of trauma and meet the criteria for inclusion in a deficit accumulation frailty index (Table 1).11 Admission FI-lab was calculated as described previously14 and was stratified into 3 groups according to the system proposed by Searle and associates15: FI < 0.25 is mild frailty, 0.25 ≤ FI ≤ 0.4 is moderate frailty, and FI > 0.4 is severe frailty. (Appendix2)

 

Patient will be followed after surgery.  All the in hospital complications should be noted and also the total length of stay including ward and ICU. Patients co morbid condition and the multiple drugs he is taking will be noted.

 

 
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