NCT06088966

Brief Summary

Investigation of the effects of negative pressure ventilation after cardiac surgery in adults onto performance of the left and right heart and the lungs.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 18, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

October 18, 2023

Status Verified

October 1, 2023

Enrollment Period

5 months

First QC Date

October 3, 2023

Last Update Submit

October 11, 2023

Conditions

Cardiac Output, Low

Outcome Measures

Primary Outcomes (1)

  • Stroke Volume Index in ml/m2

    1 hour

Secondary Outcomes (10)

  • Heart rate in beats/min

    1 hour

  • blood pressure in mm/Hg

    1 hour

  • arterial oxygen saturation in %

    1 hour

  • mixed venous oxygen saturation in %

    1 hour

  • right ventricular ejection fraction in %

    1 hour

  • +5 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients after surgery without exclusion criteria

You may qualify if:

  • patients with pulmonary artery catheter after cardiac surgery

You may not qualify if:

  • minimally invasive surgery
  • unstable conditions
  • bleeding
  • unability to fit cuirass

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum Karlsburg, Klinik für Anästhesiologie

Karlsburg, Mecklenburg-Vorpommern, 17495, Germany

RECRUITING

Related Publications (1)

  • Schemke S, Grunewald H, Schemke L, Franzen K, Hirschl D, Heringlake M, Muras L. A pilot study on the hemodynamic effects of negative pressure ventilation in patients after cardiac surgery focussing on right ventricular function. Sci Rep. 2025 Jul 31;15(1):27974. doi: 10.1038/s41598-025-12534-1.

    PMID: 40744972DERIVED

MeSH Terms

Conditions

Cardiac Output, Low

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Matthias Heringlake, Prof. Dr.

CONTACT

004938355700anaesthesie.karlsburg@klinikumkarlsburg.de

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor and head of the department of anesthesiology and intensive care Prof. Dr. Matthias Heringlake

Study Record Dates

First Submitted

October 3, 2023

First Posted

October 18, 2023

Study Start

August 1, 2023

Primary Completion

January 1, 2024

Study Completion

April 1, 2024

Last Updated

October 18, 2023

Record last verified: 2023-10

Locations

DE(1)