| CTRI Number |
CTRI/2019/08/020814 [Registered on: 21/08/2019] Trial Registered Prospectively |
| Last Modified On: |
16/08/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
A CLINICAL TRIAL TO MEASURE RESPONSE TO FLUIDS IN AN ARTERY OF NECK(CAROTID ARTERY) AND ARTERY OF HAND (BRACHIAL ARTERY) IN AWAKE PATIENTS |
|
Scientific Title of Study
|
CORRECTED FLOW TIME MEASUREMENT IN CAROTID AND BRACHIAL ARTERY FOR ASSESSING FLUID RESPONSIVENESS IN SPONTATNEOUSLY BREATHING PATIENTS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr KALUNG MANISHA |
| Designation |
JUNIOR RESIDENT(post graduate trainee) |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room no 5011 Teaching block department of Anesthesiology Pain Medicine and Critical Care All India Institute of Medical Sciences New Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
9500542160 |
| Fax |
|
| Email |
bettykalung@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr BIKASH RANJAN RAY |
| Designation |
ASSISSTANT PROFESSOR |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room no 5011 Teaching block department of Anesthesiology Pain Medicine and Critical Care All India Institute of Medical Sciences New Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
9899323110 |
| Fax |
|
| Email |
bikashray.aiims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr BIKASH RANJAN RAY |
| Designation |
ASSISSTANT PROFESSOR |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room no 5011 Teaching block department of Anesthesiology Pain Medicine and Critical Care All India Institute of Medical Sciences New Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
9899323110 |
| Fax |
|
| Email |
bikashray.aiims@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ANESTHESIOLOGY PAIN MEDICINE AND CRITICAL CARE,AIIMS NEW DELHI 110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences New Delhi |
| Address |
Room no 5011 Teaching Block Department of Anesthesiology Pain Medicine and Critical Care All India Institute of Medical Sciences New Delhi 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Kalung Manisha |
All India Institute of Medical Sciences |
Room no 5011 Teaching Block Department of Anesthesiology Pain Medicine and Critical Care All India Institute of Medical Sciences New Delhi 110029
New Delhi
DELHI |
9500542160
bettykalung@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee for post graduate research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
INTRAVENOUS COLLOID |
6 ml/kg of intravenous colloid is administered over 10 minutes |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists I & II undergoing elective surgery |
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Newly detected carotid artery stenosis >50% during the study
3. Peripheral vascular disease
4. Systolic blood pressure 160 mm Hg
5. Pregnancy
6. Valvular heart disease
7. Cardiac rhythm other than bundle branch block
8. Left ventricular ejection fraction<50%
9. Right ventricular failure
10. Chronic obstructive pulmonary disease
11. Pulmonary hypertension
12. Chronic kidney disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate carotid and brachial artery change in corrected floe time as determined by Doppler ultrasound as a predictor of fluid responsiveness in spontaneously breathing patients |
Preoperative time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate carotid and brachial artery velocity time integral and respiratory variation of peak flow rate as a measure of fluid responsiveness in spontaneously breathing patient |
Preoperative time |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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)
|
02/09/2019 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a clinical trial to assess fluid responsiveness in carotid and brachial artery of spontaneously breathing patients after administering colloid. |