| CTRI Number |
CTRI/2018/03/012688 [Registered on: 20/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
19/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
analytical observational study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study the effect of changes in blood pressure and contractility of heart after intravascular fluid transfusion in prone position during spine surgery. |
|
Scientific Title of Study
|
The abilities of pulse pressure variation and stroke volume variation to predict fluid responsiveness in prone position during lumbar fixation surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sudeshna Padhi |
| Designation |
postgraduate trainee |
| Affiliation |
IPGMER |
| Address |
Bangur institute of neurosciences,Anaesthesia department, 52/1A, Sambhunath Pandit Street, Bhawanipur, Kolkata.
Kolkata
WEST BENGAL
700025
India |
| Phone |
9674492663 |
| Fax |
|
| Email |
drsudeshnapadhi123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Saikat Niyogi |
| Designation |
Associate Professor |
| Affiliation |
IPGMER |
| Address |
Bangur institute of neurosciences,Anaesthesia department, 52/1A, Sambhunath Pandit Street, Bhawanipur, Kolkata
Kolkata
WEST BENGAL
700025
India |
| Phone |
9831732443 |
| Fax |
|
| Email |
saikatneuro1972@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Saikat Niyogi |
| Designation |
Associate Professor |
| Affiliation |
IPGMER |
| Address |
Bangur institute of neurosciences,Anaesthesia department, 52/1A, Sambhunath Pandit Street, Bhawanipur, Kolkata
WEST BENGAL
700025
India |
| Phone |
9831732443 |
| Fax |
|
| Email |
saikatneuro1972@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangur Institute of Neurosciences,52/1A, Sambhunath Pandit Street, Bhowanipore, Kolkata, West Bengal 700025 |
|
|
Primary Sponsor
|
| Name |
Bangur Institute of Neurosciences |
| Address |
52/1A, Sambhunath Pandit Street, Bhawanipur, Kolkata |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Sudeshna Padhi |
Bangur institute of neurosciences |
Anaesthesia department, 52/1A, Sambhunath Pandit Street, Bhawanipur, Kolkata 700025
Kolkata
WEST BENGAL |
9674492663
drsudeshnapadhi123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGMER Institutional Ethecal Comitte COMMITE ,IPGMER, KOLKATA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
posted for lumbar fixation surgery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)Adult patients between 20-65years
2)ASA 1&2
3)Patients of both sexes
4.Patients scheduled for elective lumbar fixation surgery in BIN OT.
|
|
| ExclusionCriteria |
| Details |
1.Patient refusal
2.Age<20 years
3.Patients with arrhythmia
4.BMI>40 or <15kg/m2
5.LVEF<50%
6.Patients with history of lung diseases
7.ASA 3 & 4
8.Autonomic dysfunction
9.Peripheral vascular disease
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| evaluate the abilities of pulse pressure variation( PPV) and stroke volume variation (SVV) to predict fluid responsiveness in prone position |
Two sets of measurements were performed in supine position(T1 and T2) and three in prone position(T3,T4 and T5).
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| changes in systolic arterial pressure, mean arterial pressure, diastolic arterial pressure, heart rate (HR) and cardiac output (CO) |
same time points of primary outcome |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2016 |
| Date of Study Completion (India) |
31/12/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
1) Biasis M, Bernard O, Ha JC, Degryse C, Sztark F. Abilities of pulse pressure variations and stroke volume variations to predict fluid responsiveness in prone position during scoliosis surgery. BJA 2010 Feb;104(4):407–413 (2010) doi:10.1093/bja/aeq031.
2) Achar SK, Sagar MS, Shetty R, Kini G, Samanth J, Nayak C, et al. Respiratory variation in aortic peak flow velocity and inferior vena cava distensibility as indices of fluid responsiveness in anaesthetized and mechanically ventilated children. Indian J Anaesth. 2016 Feb;60(2):121-126.
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The aim of our study was to evaluate the ability of PPV and SVV to predict fluid responsiveness in mechanically ventilated patients in the prone position (PP) during lumbar fixation surgery. For the study we enrolled sixty subjects who were studied after the induction of anaesthesia in the supine position [before and after volume expansion (VE) with 500 ml of hetastarch 6%] and in PP [immediately after PP and before and after (VE)]. PPV, SVV, cardiac output (CO), and mean arterial pressure(MAP) were recorded at each interval. Subjects were defined as responders (Rs) to VE if CO increased ≥15%. Finding
We found that in the supine position, 42 subjects were Rs. Fluid responsiveness was predicted in supine position by PPV >11.6% (sensitivity=97.6%, specificity=94.44%) and by SVV >13% (sensitivity=80.95%, specificity=100%). PP induced an increase in PPV and SVV (P<0.0001). In PP, 34 patients were Rs. In PP PPV and SVV before VE were correlated with VE-induced changes in CO. Fluid responsiveness was predicted in PP by PPV >13% (sensitivity=97.06%, specificity=96.15%) and by SVV >14% (sensitivity=100%, specificity=100%). Results
So, from our study we concluded that functional haemodynamic parameters like PPV and SVV are robust indicators of fluid responsiveness of patients. Even though PP induces a significant increase in PPV and SVV but does not alter their abilities to predict fluid responsiveness. Thus, PPV and SVV can be used as powerful parameters to predict fluid responsiveness of patients even in PP. |