Non-invasive hemodynamic monitoring of awake patients during caesarean section under spinal anesthesia - a prospective, randomized, single-blinded study for the detection of hypotension

Non-invasive hemodynamic monitoring of awake patients during caesarean section under spinal anesthesia - a prospective, randomized, single-blinded study for the detection of hypotension - Hypo-Caesar

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

DRKS

Registry ID

DRKS00030646

Enrollment

Registered

2022-11-08

Start date

2023-01-23

Completion date

Unknown

Last updated

2025-10-06

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

Conditions

O82

Interventions

Group 1: NIBP - open to BP control + Acumen IQ Cuff - blinded Group 2: Acumen IQ Cuff - open to BP control + NIBP - open

control

Eligibility

Sex/Gender

Female

Age

18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: 1. Written Consent 2. planned, elective caesarean section 3. Age = 18 years 4. ASA II-III

Exclusion criteria

Exclusion criteria: 1. Patient's refusal to participate 2. Language barrier 3. Participation in other clinical study 4. Age 35kg/m2 8. Childhood Complications 9. intraoperative: change of procedure in the anesthetic procedure

Design outcomes

Primary

Measure	Time frame
Number of BP values < threshold 65 mmHg Number of HPI alarms	—

Secondary

Measure	Time frame
1) Min and Max blood pressure values (MAP) 2) IV infusion therapy (ml) 3) Vasopressors (Phenylephrine; Cafedrine/Theodrenaline mg) 4) Blood Loss (ml) 5) Frequencies: nausea (yes/no) vomiting (number)	—

Countries

Germany

Contacts

Public ContactUlrich Frey

Ruhr-Universität Bochum Marienhospital HerneKlinik für Anästhesiologie, operative Intensivmedizin,Schmerz- und Palliativmedizin

ulrich.frey@ruhr-uni-bochum.de+49 2323 499 1401

Outcome results

None listed

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