| CTRI Number |
CTRI/2020/10/028332 [Registered on: 09/10/2020] Trial Registered Prospectively |
| Last Modified On: |
27/04/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Correlation of preoperative fluid status of patient (Inferior Vena Cava collapsibility) with preoperative fasting status, patient demography and general anaesthesia induced hypotension: a prospective, observational study |
|
Scientific Title of Study
|
Correlation of IVC collapsibility with preoperative fasting status, patient demography and general anaesthesia associated hypotension: a prospective, observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jyotsna Agarwal |
| Designation |
Associate Professor (Anaesthesia) |
| Affiliation |
Hamdard Institute of Medical Sciences and Research |
| Address |
N-9 GREEN PARK MAIN NEW DELHI
Block D, Hamdard Nagar, New Delhi, Delhi 110062
South
DELHI
110016
India |
| Phone |
09650252828 |
| Fax |
|
| Email |
jyotsna_mamc@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jyotsna Agarwal |
| Designation |
Associate Professor (Anaesthesia) |
| Affiliation |
Hamdard Institute of Medical Sciences and Research |
| Address |
N-9 GREEN PARK MAIN NEW DELHI
Block D, Hamdard Nagar, New Delhi, Delhi 110062
DELHI
110016
India |
| Phone |
09650252828 |
| Fax |
|
| Email |
jyotsna_mamc@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Jyotsna Agarwal |
| Designation |
Associate Professor (Anaesthesia) |
| Affiliation |
Hamdard Institute of Medical Sciences and Research |
| Address |
N-9 GREEN PARK MAIN NEW DELHI
Block D, Hamdard Nagar, New Delhi, Delhi 110062
DELHI
110016
India |
| Phone |
09650252828 |
| Fax |
|
| Email |
jyotsna_mamc@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Hamdard Institute of Medical Sciences and Research, New Delhi |
|
|
Primary Sponsor
|
| Name |
Hamdard Institute of Medical Sciences and Research |
| Address |
Hamdard Nagar, New Delhi 110062 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr Jyotsna Agarwal |
Hamdard Institute of Medical Hakeem Abdul Hameed Centenary Hospital, New Delhi |
Block D, Hamdard Nagar, New Delhi, Delhi 110062
South
DELHI |
9650252828
jyotsna_mamc@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Hamdard Institute of Medical Sciences and Research and associated HAH centenary hospital |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R888||Abnormal findings in other body fluids and substances, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Consecutive adult patients of age 18 years and above,posted for elective non cardiac, non-obstetric surgery in Hakeem Abdul Hameed Centenary Hospital, New Delhi will be studied
|
|
| ExclusionCriteria |
| Details |
1. ASA grade 3 or above
2. All pregnant patients and patients with intraabdominal mass
3. All patients on medication for hypertension
4. Patients with underlying cardiovascular disease, previous cardio-thoracic interventional procedures/ surgeries
5. Patients who cannot lie in supine position
6. Patients on positive pressure ventilation
7. Patients requiring central neuraxial block before induction of general anesthesia
8. Patients with acute trauma and hemorrhage
9. Patients for emergency surgery
|
|
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Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
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Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To determine the effect of preoperative fasting status on Inferior Vena Cava (IVC) diameter and IVC collapsibility
2. To determine the correlation between preoperative IVC collapsibility and general anesthesia associated hypotension.
|
At the time of IVC ultrasound assessment. General Anaesthesia associated hypotension measured upto 15 minutes after induction of anaesthesia or till incision is given, whichever is earlier. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To determine the correlation between patient age and IVC diameter and collapsibility
2. To determine the seasonal variation in IVC diameter and collapsibility
|
At the time of IVC ultrasound assessment |
|
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Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
Final Enrollment numbers achieved (Total)= "132"
Final Enrollment numbers achieved (India)="132" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/10/2020 |
| Date of Study Completion (India) |
24/12/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not published anywhere in parts or full |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Pre-existing hypovolemia is a known risk factor for postinduction hypotension. Of these, preoperative fasting is in particular, of interest to anaesthesiologist as it is readily modifiable. The effects of prolonged preoperative fasting on intravascular volume status needs to be determined. Ultrasound guided measurement of IVC collapsibility index (IVCCI) has been used to predict volume responsiveness and intraoperative hypotension in recent studies. In this study we aim to determine the correlation of preoperative volume status, as assessed by ultrasound (abdominal subxyphoid / subcostal view) guided IVC diameter (dIVC) and IVCCI, with preoperative fasting and patient demographics. The correlation of dIVC and IVCC with post-induction hypotension will also be determined It will be a randomized, prospective, observational, double blind study. Total of 110 consecutive adult patients posted for surgery will be studied over a period of 6-9 months. No previous studies are present on correlation of Inferior Vena Cava diameter and collapsibility with preoperative fasting status. Seasonal variation of the same has also never been studied. Any significant correlation found in this study can help in modifying fasting guidelines and predicting intraoperative hypotension in patients preoperatively.
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