Prospective investigation of the Hypotension Prediction Index and other haemodynamic parameters using the HemoSphere system in patients undergoing fetoscopic surgery

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00033180

Enrollment

Registered

2023-12-06

Start date

2023-06-15

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

O26.5

Interventions

Group 1: Pregnant patients undergoing fetal surgery for spina bifida / myelomeningocele. In this study, we are investigating pregnant women undergoing fetal surgery for spina bifida / myelomeningoce

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Patients undergoing a foetoscopic procedure - signed declaration of consent for inclusion in the examination

Exclusion criteria

Exclusion criteria: - Patients < 18 years of age - Patients without already established invasive blood pressure measurement - Patients who do not wish to participate in the examination (i.e. no signed consent form is available)

Design outcomes

Primary

Measure	Time frame
Reliability of the Hypotension Prediction Index (HPI) to consider hypotension as probable before the event occurs (HPI value > 85%)	—

Secondary

Measure	Time frame
- Mean arterial blood pressure (MAP) - Eadyn (dynamic arterial elasticity) - Stroke volume (SV), stroke volume variation (SVV), stroke volume index (SVI) - Cardiac Output (CO), Cardiac Index (CI) - Systemic vascular resistance (SVR), indexed systemic vascular resistance (SVRI) - Maximum rate of intraventricular pressure rise (dP/dtmax) - Serum lactate (blood gas analysis) - Sum and type of infused volume (e.g. crystalloids, colloids) - Sum and type of circulatory drugs used (e.g. noradrenaline, cafedrine/theoderenaline)	—

Measure

Time frame

- Mean arterial blood pressure (MAP) - Eadyn (dynamic arterial elasticity) - Stroke volume (SV), stroke volume variation (SVV), stroke volume index (SVI) - Cardiac Output (CO), Cardiac Index (CI) - Systemic vascular resistance (SVR), indexed systemic vascular resistance (SVRI) - Maximum rate of intraventricular pressure rise (dP/dtmax) - Serum lactate (blood gas analysis) - Sum and type of infused volume (e.g. crystalloids, colloids) - Sum and type of circulatory drugs used (e.g. noradrenaline, cafedrine/theoderenaline)

—

Countries

Germany

Contacts

Public ContactBenjamin Vojnar

UKGM - Klinik für Anästhesie und Intensivtherapie am Standort Marburg

vojnar@med.uni-marburg.de004964215861123

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026