Cerebral Oximetry, Pulmonary Artery Catheter Parameters a... | NCT07526181

Studies
Cerebral Oximetry, Pulmonary Artery Catheter Parameters and ECMO Flow in Patients Supported With Veno-arterial ECMO

NCT07526181

Sponsor

Assiut University

Status

Not yet recruiting

Last Update Posted

Apr 13, 2026Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Mechanical Circulatory Support

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 20, 2026Estimated

Primary Completion Date

May 1, 2027Estimated

Completion Date

Jun 30, 2027Estimated

First Submitted Date

Apr 4, 2026

First Submission Date that Met QC Criteria

Apr 10, 2026

First Posted Date

Apr 13, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2026

Last Update Posted Date

Apr 13, 2026Actual

Name	Class
Cairo University/ECMO unit	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

for patients connected to VA ECMO due to cardiogenic shock, monitoring:

Cerebral Oximetry
ECMO Parameters ECMO blood flow (L/min) every 12 hours. Sweep gas flow Cannulation configuration
Pulmonary Artery Catheter Data and hemodynamics:

Cardiac output / cardiac index, SvO₂, Central venous pressure (CVP).
other variables: P/F ratio, MAP, Heart rate, Arterial blood gases, hemoglobin, Lactate, Vasopressor / inotrope doses and Sedation score (RASS).
Echocardiography parameters: recorded every 12 hours. LV ejection fraction. LVOT VTi. LVED dimension. Aortic valve opening.
Follow-up data:
- ECMO duration.
- Need for oxygen therapy/mechanical ventilation.
- ICU survival.

Detailed Description

for patients connected to VA ECMO due to cardiogenic shock, monitoring:

Cerebral Oximetry

Bilateral frontal sensors, rScO₂ recorded:

at baseline (within 1 hour of ECMO initiation) then every 12 hours.
ECMO Parameters Pump speed (RPM) ECMO blood flow (L/min) every 12 hours. Sweep gas flow Cannulation configuration Arterial cannulation site
Pulmonary Artery Catheter Data and hemodynamics:

Cardiac output / cardiac index every 12 hours. SvO₂. Central venous pressure (CVP) Mean pulmonary artery pressure. Pulmonary capillary wedge pressure. Systemic vascular resistance.
Echocardiography parameters: recorded every 12 hours. LV ejection fraction. LVOT VTi. LVED dimension. Aortic valve opening.
Other variables:

P/F ratio. MAP. Heart rate. Arterial blood gases. Lactate. Hemoglobin. Vasopressor / inotrope doses. Sedation score (RASS).
Follow-up data:
- ECMO duration.
- Need for oxygen therapy/mechanical ventilation.
- ICU survival.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
correlation between native cardiac output/ Extracorporeal membrane oxygenation flow ratio and regional cerebral tissue oxygen saturation		from date of randomization until the date of ending the ECMO support (assessed up to 100 weeks)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 years
Patients supported with veno-arterial ECMO.
Presence of a pulmonary artery catheter.
Expected ECMO support ≥ 24 hours.
Patient with good echocardiographic window.

Exclusion Criteria:

Pre-existing severe neurological injury (e.g. massive stroke, traumatic brain injury).
Intracranial pathology affecting NIRS reliability.
Facial or scalp conditions preventing NIRS probe placement.
ECMO duration < 48 hours.
Poor echocardiographic window.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

patient, aged more than 18 years old with cardiogenic shock unresponsive to conventional medical treatment and supported with VA ECMO.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Doaa Roshdy Abdul satar, assistant lecturer	Contact	2001024588594		doaa.elenany@yahoo.com

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided