| CTRI Number |
CTRI/2025/12/099287 [Registered on: 17/12/2025] Trial Registered Prospectively |
| Last Modified On: |
16/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to find out whether the difference in blood pressure can detect changes in heart function in severely ill patients. |
|
Scientific Title of Study
|
Can pulse pressure assessment at the bedside detect low values or track changes of stroke volume in critically ill patients? The multicenter, cross-sectional, observational, ANDROMEDA PEGASUS Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 5079_Version 1.2 dated 15.10.2024 |
Protocol Number |
| NCT06737614 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sheila Nainan Myatra |
| Designation |
Professor, Department of Anaesthesiology, Critical Care and Pain |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Anesthesia, Critical care and Pain, Major OT complex, Second floor, Main Building, Tata Memorial Hospital Dr E Borges Road Parel Mumbai
Mumbai MAHARASHTRA 400012 India |
| Phone |
9820156070 |
| Fax |
|
| Email |
sheila150@hotmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sheila Nainan Myatra |
| Designation |
Professor, Department of Anaesthesiology, Critical Care and Pain |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Anesthesia, Critical care and Pain, Major OT complex, Second floor, Main Building, Tata Memorial Hospital Dr E Borges Road Parel Mumbai
Mumbai MAHARASHTRA 400012 India |
| Phone |
9820156070 |
| Fax |
|
| Email |
sheila150@hotmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sheila Nainan Myatra |
| Designation |
Professor, Department of Anaesthesiology, Critical Care and Pain |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Anesthesia, Critical care and Pain, Major OT complex, Second floor, Main Building, Tata Memorial Hospital Dr E Borges Road Parel Mumbai
Mumbai MAHARASHTRA 400012 India |
| Phone |
9820156070 |
| Fax |
|
| Email |
sheila150@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital Dr E Borges Road Parel Mumbai 400012 |
|
|
Primary Sponsor
|
| Name |
Tata Memorial hospital |
| Address |
Department of Anesthesia Critical Care and Pain, Tata Memorial Hospital Mumbai 400012 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Germany India Sweden |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sheila N Myatra |
Tata Memorial Hospital |
Department of Anesthesia, Critical care and Pain, Major OT complex, Second floor, Main Building, Tata Memorial Hospital Dr E Borges Road Parel Mumbai. Mumbai MAHARASHTRA |
9820156070
sheila150@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Memorial Hospital_Institutional Ethics Committee II |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
98.00 Year(s) |
| Gender |
Both |
| Details |
1 more than 18 years old Admitted to ICU
2 Functioning arterial line in place |
|
| ExclusionCriteria |
| Details |
1 Pregnancy o Inadequate arterial line transduction
2 Severe peripheral vasculopathy
3 Refusal of consent
4 Patient who requires extracorporeal circulation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pulse Pressure and LVOT-VTI |
Day 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
- To assess the predictive capacity of PP to detect low SV in different clinical contexts in ICU patients, such as in those with acute respiratory distress syndrome (ARDS), postoperative states, or septic shock, among others.
- To assess the impact of several demographic, clinical & technical issues on the predictive capacity of PP to estimate SV, such as mechanical ventilation, vasoactive medication, age, position of the arterial line, among others.
- To determine the capacity of PP to track changes of SV during common intensive care interventions such as passive leg raising (PLR) maneuver, fluid challenges,
vasoactive drug initiation or titration, or ventilatory-related maneuvers such as positive end-expiratory pressure (PEEP) titration & recruitment maneuvers,
among others. |
Day 1 |
|
|
Target Sample Size
|
Total Sample Size="1000" Sample Size from India="20"
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)
|
31/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
31/12/2025 |
| 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
|
Critically ill patients often have complex cardiovascular problems that reduce the delivery of oxygen to the tissues, causing organs to fail. A crucial step in treatment is monitoring tissue perfusion and identifying the main patterns of blood flow (hemodynamic patterns) to guide resuscitation and break this harmful cycle. In emergency settings, such as the emergency department or the intensive care unit, and in places with limited resources, initial resuscitation decisions might have to be based on very basic clinical information. Furthermore, many treatments given in the intensive care unit, including fluids, diuretics, drugs that affect blood vessel tone (vasoactive drugs), and maneuvers related to the ventilator, can negatively affect the stroke volume in ways that may go unnoticed because specific hemodynamic monitors are not used on all patients. Recently, capillary refill time, a quick and simple clinical tool used at the bedside, has been suggested as a way to evaluate tissue perfusion or even as a goal for treating septic shock. Capillary refill time is appealing because it is free of cost, noninvasive, and easy to use in many clinical situations. Unfortunately, there is no simple and widely available clinical monitor that provides similar information about overall blood flow (macrohemodynamic perspective), especially to detect a potentially low stroke volume. This low stroke volume could be due to the underlying circulatory problem or an unwanted side effect of common intensive care unit treatments. The text explores the question of whether monitoring pulse pressure at the bedside can be useful for detecting very low values of stroke volume or tracking its changes. Pulse pressure has a strong basis in physiology as a reflection of stroke volume. The authors question the limitations and factors that could affect the relationship between pulse pressure and stroke volume, which would help clinicians use pulse pressure as an early warning sign. The most important clinical question is whether monitoring pulse pressure after intensive care unit admission can detect a low stroke volume so that corrective actions can be taken while more advanced testing, such as pointofcare ultrasound, is being performed. If this simple and costless tool can be validated, it could become a firstline approach for assessing overall blood flow, which would be particularly valuable in resource limited settings or where advanced monitoring is not immediately accessible. Research Questions and ObjectivesResearch Question In critically ill patients, does pulse pressure, measured through an invasive arterial line, accurately predict stroke volume, as measured by bedside echocardiography (ultrasound)? Hypothesis: Pulse pressure will be able to adequately detect low values of stroke volume and track its changes during commonly used dynamic cardiovascular interventions.
Primary Objective Secondary Objectives To assess the ability of pulse pressure to predict low stroke volume in different clinical situations in intensive care unit patients, such as those with acute respiratory distress syndrome, after surgery, or with septic shock. To evaluate the impact of various factors (like mechanical ventilation, vasoactive medication, age, and the position of the arterial line) on the predictive ability of pulse pressure to estimate stroke volume. To determine the capacity of pulse pressure to track changes in stroke volume during common intensive care interventions such as the passive leg raising maneuver, fluid challenges, starting or adjusting vasoactive drugs, or ventilator related maneuvers like adjusting positive end expiratory pressure and recruitment maneuvers. |