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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 Objectives

Research 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

  • To determine how well pulse pressure can predict a low stroke volume, assessed by bedside ultrasonography, in critically ill patients.

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.

 
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