| CTRI Number |
CTRI/2025/04/084700 [Registered on: 13/04/2025] Trial Registered Prospectively |
| Last Modified On: |
09/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Role of neck ultrasound in assessing whether the patient require fluids after surgery |
|
Scientific Title of Study
|
CAROTID ULTRASOUND MEASUREMENTS FOR ASSESSING FLUID RESPONSIVENESS IN SPONTANEOUSLY BREATHING POST OPERATIVE ABDOMINAL ONCO-SURGERY PATIENTS |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
HARSIMRAN SINGH WALIA |
| Designation |
associate professor |
| Affiliation |
Homi Bhabha Cancer Hospital and research centre, New Chandigarh |
| Address |
homi bhabha cancer hospital- New Chandigarh- punjab
Sangrur
PUNJAB
140901
India |
| Phone |
09960375222 |
| Fax |
|
| Email |
harsimranwalia@ymail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
HARSIMRAN SINGH WALIA |
| Designation |
associate professor |
| Affiliation |
Homi Bhabha Cancer Hospital and research centre, New Chandigarh |
| Address |
Homi Bhabha cancer hospital- New Chandigarh
Sangrur
PUNJAB
140901
India |
| Phone |
09960375222 |
| Fax |
|
| Email |
harsimranwalia@ymail.com |
|
Details of Contact Person
Public Query
|
| Name |
HARSIMRAN SINGH WALIA |
| Designation |
associate professor |
| Affiliation |
Homi Bhabha Cancer Hospital and research centre, New Chandigarh |
| Address |
homi bhabha cancer hospital- New Chandigarh- punjab
Sangrur
PUNJAB
140901
India |
| Phone |
09960375222 |
| Fax |
|
| Email |
harsimranwalia@ymail.com |
|
|
Source of Monetary or Material Support
|
| Homi Bhabha Cancer Hospital- New Chandigarh-
Anesthesia department- 5th floor OT complex
Punjab-140901 |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
NA |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| harsimran singh walia |
homi bhaba cancer hospital and research centre, new chandigarh |
OT COMPLEX- 5TH FLOOR- DEPARTMENT OF ANAESTHESIA, CRITICAL CARE AND PAIN
Sangrur
PUNJAB |
09960375222
harsimranwalia@ymail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC HBCHRC, NEW Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C269||Malignant neoplasm of ill-definedsites within the digestive system, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
DVPeak after fluid as a measure of fluid responsiveness |
DV Peak will be measured as a measure of fluid responsiveness after giving fluid bolus |
| Intervention |
FTc after giving IV fluid bolus |
Postoperative patients meeting the inclusion criteria will be included in the study after approval from IEC. First, baseline carotid FTc, DVpeak, stroke volume index (SVI), and haemodynamic data will be measured. After recording these data, the patients will be administered a fluid challenge of 6 ml/ kg ideal body weight of ringer lactate over 10 min. Five minutes after completion of the fluid challenge, the same haemodynamic parameters will be measured again. No vasoactive medications will be administered during the measurement period, and all measurements will be obtained while the patients were haemodynamically stable. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18 years to 80 years
2. left ventricular outflow track time integral greater than 15%
3.SBP less than 90mm hg
4. Hear rate more than 100/min
5. Urine output less than 0.5ml/kg/hour
|
|
| ExclusionCriteria |
| Details |
1. Pregnancy
2. Chronic kidney disease on Hemodialysis
3. BMI more than 35 or less than 15
4. Presence of carotid artery stenosis
5.cardiac arrthymias
6. patients of vasopressors |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The aim of this study will be to compare carotid FTc as determined by Doppler ultrasound versus DVpeak for fluid responsiveness in spontaneously br
eathing patients as a predictor of fluid responsiveness in spontaneously breathing patients after abdominal oncosurgery.
|
The aim of this study will be to compare carotid FTc as determined by Doppler ultrasound versus DVpeak for fluid responsiveness in spontaneously br
eathing patients as a predictor of fluid responsiveness in spontaneously breathing patients after abdominal oncosurgery.
TO BE ASSESSED FROM POST OPERATIVE DAY-0 TILL ICU DISCHARGE
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Heart rate, mean arterial pressure, Systolic blood pressure, Diastolic blood pressure and respiratory rate will be noted |
Postoperative period |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
21/04/2025 |
| 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)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
We will compare FTc and DV peak as a marker of fluid responsiveness in patients who are administered fluids in postoperative period. |