| CTRI Number |
CTRI/2024/04/064995 [Registered on: 01/04/2024] Trial Registered Prospectively |
| Last Modified On: |
29/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
A comparison of pulse pressure variability and inferior vena cava dispensability index for predicting fluid responsiveness |
|
Scientific Title of Study
|
A comparative study of pulse pressure variability and inferior vena cava dispensability index for evaluation of fluid responsiveness at 2 different tidal volumes during mechanical ventilation |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sona Dave |
| Designation |
Professor |
| Affiliation |
TNMC BYL Nair Ch. Hospital |
| Address |
Department of Anaesthesia, 403, Fourth floor, College Building, TNMC BYL Nair Ch. Hospital
A L Nair Road, Mumbai central, Mumbai 4C Bindiya, Bandra Reclamation Road, Bandra west, Mumbai 400050 Mumbai MAHARASHTRA 400008 India |
| Phone |
09820067731 |
| Fax |
|
| Email |
sonadave@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Sona Dave |
| Designation |
Professor |
| Affiliation |
TNMC BYL Nair Ch. Hospital |
| Address |
Department of Anaesthesia, 403, Fourth floor, College Building, TNMC BYL Nair Ch. Hospital
A L Nair Road, Mumbai central, Mumbai 4C Bindiya, Reclamation area, Bandra west, Mumbai 400050 Mumbai MAHARASHTRA 400008 India |
| Phone |
09820067731 |
| Fax |
|
| Email |
sonadave@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Yogesh Ganesh Chawat |
| Designation |
Junior Registrar |
| Affiliation |
TNMC BYL Nair Ch. Hospital |
| Address |
Department of Anaesthesia,
403
Fourth floor,
College building, A L Nair Road,
Mumbai Central
Mumbai Mumbai MAHARASHTRA 400008 India |
| Phone |
09820067731 |
| Fax |
|
| Email |
yugalkirtan.rns@gmail.com |
|
|
Source of Monetary or Material Support
|
| TNMC and BYL Nair Ch. Hospital, A L Nair Road, Mumbai Central, Mumbai. PIN 400008 |
|
|
Primary Sponsor
|
| Name |
TNMC and BYL Nair Ch. Hospital |
| Address |
TNMC and BYL Nair Ch. Hospital Mumbai Central Mumbai 400008 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| self |
TNMC and BYL Nair Ch. Hospital |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sona Dave |
TNMC BYL Nair Ch Hospital |
Department of Anaesthesia, 403, Fourth floor, College building, Mumbai Central , Mumbai 400008 Mumbai MAHARASHTRA |
09820067731
sonadave@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Academic Research Projects (ECARP) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: G939||Disorder of brain, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fluid challenge |
Fluid challenge: Ringers lactate solution will be infused intravenously over a 10-min period with a total infusion volume of 6 mL per kg that served to observe fluid responsiveness. The parameters will be noted with tidal volumes of 8 and 10 mL per kg before and immediately after the fluid challenge. Total duration will be 18 minutes. |
| Comparator Agent |
Same patient will be assessed post intervention. |
Fluid challenge: Ringers lactate solution will be infused intravenously over a 10-min period with a total infusion volume of 6 mL per kg that served to observe fluid responsiveness. The parameters will be noted with tidal volumes of 8 and 10 mL per kg before and immediately after the fluid challenge. Total duration will be 18 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients posted for routine major surgeries in plastic and neurosurgery OT under general anaesthesia and mechanical ventilation
Arterial cannulation done as a part of routine protocol
ASA 1 and 2 |
|
| ExclusionCriteria |
| Details |
Pregnancy,
Patients with cardiac and respiratory ailments
Raised intracranial pressure
Contraindication of fluid challenge (acute coronary syndrome, cardiac shock, and evidence of
capacity overload) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Accuracy of PPV in predicting volume responsiveness can be increased by increasing TV. Optimal TV that enables best diagnostic value is 10 ml/kg. The diagnostic value of PPV is higher than that of IVC DI. |
TV adjustment will be carried out after about 10 min when the hemodynamics of the patient
become stable.
The TV will be adjusted to 8 mL/kg.
The parameters will be recorded.
The TV will be adjusted to 10 mL/kg after 2 min.
The indices will be recorded after maintenance for 2 min.
Then Fluid challenge will be given.
The tidal volumes of 8 and 10 mL/kg will be adjusted immediately after the fluid challenge and
maintained for 2 min, and then the above indices will be recorded again.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in VTI with fluid challenge |
TV adjustment will be carried out after about 10 min when the hemodynamics of the patient
become stable.
The TV will be adjusted to 8 mL/kg.
The parameters will be recorded.
The TV will be adjusted to 10 mL/kg after 2 min.
The indices will be recorded after maintenance for 2 min.
Then Fluid challenge will be given.
The tidal volumes of 8 & 10 mL/kg will be adjusted immediately after the fluid challenge and
maintained for 2 min, & then the above indices will be recorded again.
|
|
|
Target Sample Size
|
Total Sample Size="39" Sample Size from India="39"
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)
|
10/04/2024 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Hypovolemia leading to hypotension after induction of
anaesthesia is common occurrence due to action of anaesthetic drugs and pre-op
starvation. Intra operative hypotension has been implicated as major
contributing factor for post-operative morbidity; it may prolong hospital stay
and is associated with major postoperative complications including acute kidney
injury, myocardial injury and death. Thus, intra-operative fluid resuscitation
plays a major role in maintaining the hemodynamic stability in surgical
patients This study is a comparative study of pulse pressure variability and
inferior vena cava dispensability index for evaluation of fluid responsiveness
at 2 different tidal volumes during mechanical ventilation. Approval for
conducting the study will be taken from Institutional Ethics Committee.
Patients for the study will be selected by simple random sampling method from
those who fulfil the inclusion criteria. A multipara monitors with facility to
measure PPV from arterial pressure waveforms and record vital signs of the
patients will be used. Routine anaesthesia induction with 1.5–2.5 mg/kg
Propofol, 0.5 mg/kg Atracurium (0.6– 1.0 mg/kg Rocuronium) .TV adjustment will
be carried out after about 10 min when the hemodynamics of the patient become
stable. If hypotension occurs during the surgery before giving bolus, it will
be treated as per standard protocol by fluid infusion or drug therapy. The TV will
be adjusted to 8 mL/kg and the respiratory rate will be maintained at 9
cycles/min. Heart rate (HR), diastolic blood pressure, systolic blood pressure,
mean arterial pressure (MAP), PPV, peak pressure (Ppeak), plateau pressure, the
VTI of the left ventricular outflow tract, and IVC-DI will be recorded. The
velocity-time integral (VTI) of the left ventricular outflow tract will be
measured by transthoracic echocardiography. Blood flow of the left ventricular
outflow tract will be recorded by pulsed Doppler echocardiography on an apical
five-chamber view. Sample volume lines will be placed in the aortic annulus and
VTI will be measured. The IVC diameter (IVC inspiration/IVC expiration) will be
measured at the subxiphoid transabdominal long axis, the position of the
section will be 2–3 cm from the distal end of the right atrial opening of the
IVC. The diameter of the IVC at the end of inspiration (IVC inspiration) and
the diameter of the IVC at the end of expiration (IVC expiration) will also be
measured. The IVC-DI is calculated as (IVCinspiratory - IVCexpiratory)/
IVCexpiratory X 100%. The TV will be adjusted to 10 mL/kg and the respiratory
rate will be maintained at 9 cycles/min. The indices will be recorded after
maintenance for 2 min and the airflow will be maintained at 1L/min. So,
Measurements will be taken for total of 4 times -2 times before fluid infusion
and 2 times after fluid infusion. Before and after fluid infusion, tidal volume
will be adjusted to 8 and 10 ml/kg. After each adjustment measurements will be
taken. Fluid challenge: Ringer’s lactate solution (RL) will be infused
intravenously over a 10-min period with a total infusion volume of 6 mL/kg that
served to observe fluid responsiveness. The tidal volumes of 8 and 10 mL/kg
will be adjusted immediately after the fluid challenge and maintained for 2
min, and then the above indices will be recorded again. There is no grouping done before the study.
Patients with an increased VTI of the left ventricular outflow tract (▲ VTI) ⩾15% after the
fluid challenge will be classified as fluid responsive (R group) and patients
with a â–² VTI of < 15%
will be analysed and classified as fluid non-responsive (NR group). |