Cardiac Output, LowNCT06088966
Evaluation of Hemodynamic and Ventilatory Effects of Negative Pressure Ventilation
An observational study of Cardiac Output, Low, run by Karlsburg Hospital at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cardiac Output, Low
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2023to 1 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All patients after surgery without exclusion criteria
Who may be able to join
- patients with pulmonary artery catheter after cardiac surgery
Who cannot join
- minimally invasive surgery
- unstable conditions
- bleeding
- unability to fit cuirass
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Klinikum Karlsburg, Klinik für Anästhesiologie
Karlsburg, Mecklenburg-Vorpommern, 17495
Matthias Heringlake, Prof. Dr., +4938355700, anaesthesie.karlsburg@klinikumkarlsburg.de
Simon Schemke, Dr., +4938355700, anaesthesie.karlsburg@klinikumkarlsburg.de
About this study
Investigation of the effects of negative pressure ventilation after cardiac surgery in adults onto performance of the left and right heart and the lungs.
- Conditions
- Cardiac Output, Low
- Medical subject headings
- Cardiac Output, Low
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke Volume Index in ml/m2
Measured: 1 hour
Secondary outcomes (10)
Heart rate in beats/min
Measured: 1 hour
blood pressure in mm/Hg
Measured: 1 hour
arterial oxygen saturation in %
Measured: 1 hour
mixed venous oxygen saturation in %
measured via pulmonary catheter
Measured: 1 hour
right ventricular ejection fraction in %
measured via pulmonary catheter
Measured: 1 hour
end diastolic volume index in ml/m2
measured via pulmonary catheter
Measured: 1 hour
Cardiac index in l/min/m2
measured via pulmonary catheter
Measured: 1 hour
tricuspid annular plane systolic excursion in mm
measured via transesophageal echocardiography
Measured: 1 hour
right ventricular fractional area change in %
measured via transesophageal echocardiography
Measured: 1 hour
Vena contract of tricuspid valve in mm
measured via transesophageal echocardiography
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start1 Aug 2023
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac Output, LowStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karlsburg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Matthias Heringlake, Karlsburg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06088966
- Sponsor's protocol ID
- KAIKB-2023-2
- Status last verified
- Oct 2023
- First submitted
- 3 Oct 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40744972
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hemodynamic and Ventilatory Effects of Negative Pressure Ventilation
- ClinicalTrials.gov ID
- NCT06088966
- Acronym / sponsor ID
- KAIKB-2023-2
- Conditions
- Cardiac Output, Low
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Karlsburg HospitalUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigation of the effects of negative pressure ventilation after cardiac surgery in adults onto performance of the left and right heart and the lungs.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients after surgery without exclusion criteria
Key inclusion criteria (1 listed)
- patients with pulmonary artery catheter after cardiac surgery
Key exclusion criteria (4 listed)
- minimally invasive surgery
- unstable conditions
- bleeding
- unability to fit cuirass
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Stroke Volume Index in ml/m2
Time frame: 1 hour
10 secondary outcomes
Heart rate in beats/min
Time frame: 1 hour
blood pressure in mm/Hg
Time frame: 1 hour
arterial oxygen saturation in %
Time frame: 1 hour
mixed venous oxygen saturation in %
Time frame: 1 hour
right ventricular ejection fraction in %
Time frame: 1 hour
end diastolic volume index in ml/m2
Time frame: 1 hour
Cardiac index in l/min/m2
Time frame: 1 hour
tricuspid annular plane systolic excursion in mm
Time frame: 1 hour
right ventricular fractional area change in %
Time frame: 1 hour
Vena contract of tricuspid valve in mm
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Derived from this study: PubMed 40744972Schemke 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Output, Low, run by Karlsburg Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthias Heringlake, Prof. Dr. (004938355700, anaesthesie.karlsburg@klinikumkarlsburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke Volume Index in ml/m2 (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06088966, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.