| 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 |
|
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
AIIMS Hospital |
| Address |
Deptt of Anaesthesia, AIIMS, New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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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 |
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute 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: R99||Ill-defined and unknown cause of mortality, |
|
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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 |
|
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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
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
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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 |
|
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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" |
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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 |
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Publication Details
|
Nil |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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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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