| CTRI Number |
CTRI/2024/02/063146 [Registered on: 26/02/2024] Trial Registered Prospectively |
| Last Modified On: |
06/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia Other (Specify) [Tidal Volumn Challange and Fluid Therapy] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The study investigates if a brief breath volume change in a ventilator-induced patient can indicate fluid therapy response by detecting pulse pressure changes in severe breathing patients receiving breaths through machines and in a prone position. |
|
Scientific Title of Study
|
Change in PPV with Tidal Volume Challenge to assess fluid responsiveness in patients suffering from Acute Respiratory Distress Syndrome undergoing low tidal volume mechanical ventilation in prone position |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Project No 4237 Version 2.0 dated 7 Oct 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sheila N Myatra |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital, Mumbai |
| Address |
Dept of Anesthesia, Critical Care and Pain, Main Building, Second Floor, Dr E Borges Road, Parel, Mumbai
Mumbai MAHARASHTRA 400012 India |
| Phone |
9820156070 |
| Fax |
|
| Email |
sheila150@hotmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Sheila N Myatra |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital, Mumbai |
| Address |
Dept of Anesthesia, Critical Care and Pain, Main Building, Second Floor, Dr E Borges Road, Parel, Mumbai
MAHARASHTRA 400012 India |
| Phone |
9820156070 |
| Fax |
|
| Email |
sheila150@hotmail.com |
|
Details of Contact Person Public Query
|
| Name |
Masood Ali Mujawar |
| Designation |
Senior Resident |
| Affiliation |
Tata Memorial Hospital, Mumbai |
| Address |
Dept of Anesthesia, Critical Care and Pain, Main Building, Second Floor, Dr E Borges Road, Parel, Mumbai
Mumbai MAHARASHTRA 400012 India |
| Phone |
9503338184 |
| Fax |
|
| Email |
masoodmujawar864@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital, Dr E Borges Road, Parel, Mumbai-12 |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital, Mumbai |
| Address |
Dr E Borges Road, Parel, Mumbai, Maharashtra 400012 |
| 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 Masood Ali Mujawar |
Tata Memorial Hospital, Mumbai |
MB171, MB 271 Intensive care Unit, Main Building, First and Second floor, Dr E Borges Room, Parel, Mumbai MAHARASHTRA |
98503338184
masoodmujawar864@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Tata Memorial Centre-Institutional Ethics Committee |
Approved |
| Tata Memorial Centre-Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J960||Acute respiratory failure, (2) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Baseline values |
Participants baseline reading of variables before tidal volume challenge and after fluid bolus will be used as comparator |
| Intervention |
Fluid Bolus |
a fluid bolus of 250 ml of Ringers Lactate will be given over 10 minutes, and measurements will be repeated. |
| Intervention |
tidal volume challenge |
The tidal volume challenge will be performed by increasing Vt to 8 mL/kg PBW, and pulse contour cardiac index, PPV, and SVV will be recorded after 1 minute and change in PPV and SVV (delta PPV(VT) and delta-SVV(VT) will be calculated) |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1 Adult patients Age more than 18 years
2 Suffering From Acute Respiratory Distress Syndrome ARDS defined as per Berlins Criteria.
3 Undergoing mechanical ventilation via lung protective low tidal volume strategy using Volume assist control ventilation without any spontaneous breathing activity (deeply sedated/ paralyzed as seen on pressure time curve on ventilator), in prone position.
4 Having invasive continuous cardiac output monitoring using PICCO device (Pulsion Medical Systems, Feldkirchen, Germany) with Phillips Intel View monitor MP700
5 Patients of acute circulatory failure defined as the presence of systolic blood pressure (SBP) less than or equal to 90 mm Hg or mean arterial pressure (MAP) less than or equal to 70 mm Hg or requiring vasopressors to maintain SBP more than 90 or MAP more than 70 along with one or more of the following: a) urine flow less than 0.5 mL per kg per hr for more than 2hours. b) heart rate more than 100 beats per minute. c) Presence of skin mottling d) blood lactate concentration more 2 mmol per L in whom the treating physician plans to give a fluid bolus
|
|
| ExclusionCriteria |
| Details |
1 Age less than 18 years.
2 Patients with cardiac arrythmia, known valvular heart disease, intracardiac shunt, right ventricular dysfunction, air leakage through chest drains, abdominal compartment syndrome.
3 Pregnant Females
4 Patient refusing consent to participate in the study
5 Extravascular Lung water Index (EVLWI) >12 (except in those patients in whom treating clinician wishes to give a fluid bolus to the patient) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess whether change in PPV while transiently increasing tidal volume to 8ml per kg Predicted Body Weight in patients suffering from ARDS undergoing low tidal volume ventilation in prone position adequately predicts fluid responsiveness. |
30 min after starting the intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the effect of lung compliance on the validity of tidal volume challenge test to predict fluid responsiveness in patients suffering from ARDS undergoing low tidal volume ventilation in prone ventilation. |
1 months after starting the trial enrollment |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
04/03/2024 |
| 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="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Patients admitted in ICU with septic shock (spread of infection in blood)
caues low blood pressure. The first line of treatment for this is
administration of intraveous fluids called as Fluid therapy. This fluid
therapy, which involves the rapid administration of fluids in the patient’s
veins, stands as one of the fundamental treatment modalities employed in
patients afflicted by low blood pressure stemming from infection, otherwise
known as septic shock. However, it is worth noting that only a minority of
patients, specifically 50%, exhibit a positive response to fluid therapy,
evidenced by an increase in blood pressure and an amelioration of blood supply
to various organs, consequently averting the onset of organ failure.
In cases where patients display an unresponsiveness to fluid therapy, the
administration of fluids may result in deleterious consequences, such as fluid
accumulation within the lungs, which can precipitate lung congestion, thereby
exacerbating the patient’s oxygen requirement. Consequently, the ability to
accurately predict fluid responsiveness assumes paramount importance in the
effective management of patients. In light of this, several tests have been
devised with the aim of forecasting which patients will exhibit a favorable response
to fluid therapy. However, the challenge lies in those patients who are placed
in a prone position, that is, made to lie on their stomach for the purpose of
ventilation, as part of their lung problems treatment. This specific group of
patients presents a unique issue due to the lack of standardized tests
available and the technical difficulties encountered when attempting to perform
the existing tests.
To
evaluate the effectiveness of the tidal volume challenge test, we are currently
investigating one specific test. This test involves making adjustments to the
ventilator settings in order to regulate the amount of breath administered to
the patient. The breath volume is adjusted from 6ml/kg weight to 8ml/kg weight,
and the test is conducted for a duration of 1 minute. The objective of this
test is to observe the response in pulse pressure. Additionally, we will also
assess the impact of administering fluids on the patient’s heart function. This
will allow us to determine whether the reliability of pulse pressure variation
(PPV) improves after measuring it following an increase in breath volume to
8ml/kg. By conducting this study, we aim to determine whether the change in
PPV, while transiently increasing tidal volume to 8ml/kg Predicted Body Weight
(PBW) in patients suffering from Acute Respiratory Distress Syndrome (ARDS)
undergoing low tidal volume ventilation in the prone position, sufficiently
predicts fluid responsiveness.
In order
to examine the impact of lung compliance on the accuracy and reliability of the
tidal volume challenge test, which aims to predict fluid responsiveness in
patients who are experiencing acute respiratory distress syndrome (ARDS) and
are undergoing low tidal volume ventilation in the prone position, it is
crucial to thoroughly investigate the outcomes of this test. If the test
produces favorable and encouraging results, it could potentially serve as a
valuable and beneficial tool in the management and treatment of patients who
are similar to yours, ultimately leading to improved patient care and outcomes. |