Getting Unbiased Estimates of Stroke volume Study (GUESS): PRAM vs. clinical-based Cardiac Output Assessment in Children Undergoing Congenital Cardiac Surgery and Adults Undergoing Major Surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00039247

Enrollment

Registered

2026-02-10

Start date

2026-03-01

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children with congenital heart defects and adults undergoing major surgery

Interventions

Group 1: Once written consent has been obtained, everything proceeds according to clinic standards on the day of the operation. The patient is anesthetized and prepared (positioning, washing, preparat

there is no contact with the attending anesthesiologist and no influence on the anesthesiologist. The study does not change the clinic's standard practice, and no study-specific measures are taken, o

Eligibility

Sex/Gender

All

Age

1 Years to 90 Years

Inclusion criteria

Inclusion criteria: Children (0-18 years) undergoing elective cardiac surgery with indication for extended hemodynamic monitoring Adults (18-90 years) undergoing elective major surgery with indication for extended hemodynamic monitoring

Exclusion criteria

Exclusion criteria: Children and adults without advanced hemodynamic monitoring Lack of informed consent

Design outcomes

Primary

Measure	Time frame
Absolute deviation between measured and estimated HZV in ml/min	—

Secondary

Measure	Time frame
Absolute deviation between measured and estimated cardiac output in ml/min/m2 Relative deviation between measured and estimated cardiac output in percent Correlation between clinically estimated cardiac output and PRAM cardiac output Agreement in the categories “cardiac output = low,” “cardiac output = normal,” “cardiac output = high” Is there a systematic error? (Overestimation or underestimation) What is the therapeutic consequence of the clinical HCV estimate? What is the therapeutic consequence of the PRAM measurement? Subgroup analysis (e.g., single ventricle, cyanotic defects, age groups, weight classes)	—

Measure

Time frame

Absolute deviation between measured and estimated cardiac output in ml/min/m2 Relative deviation between measured and estimated cardiac output in percent Correlation between clinically estimated cardiac output and PRAM cardiac output Agreement in the categories “cardiac output = low,” “cardiac output = normal,” “cardiac output = high” Is there a systematic error? (Overestimation or underestimation) What is the therapeutic consequence of the clinical HCV estimate? What is the therapeutic consequence of the PRAM measurement? Subgroup analysis (e.g., single ventricle, cyanotic defects, age groups, weight classes)

—

Countries

Germany

Contacts

Public ContactEhrenfried Schindler

Universitätsklinikum Bonn

Ehrenfried.Schindler@ukbonn.de0228-28737595

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026