Negative Pressure VentilationNCT06572072
Effects of Negative Pressure Ventilation on Right Ventricular Function in Cardiological Patients
An observational study of Negative Pressure Ventilation and Right Ventricular Dysfunction, run by Karlsburg Hospital at 1 site in Germany.
Trial summary
Patients receives induction of general anesthesia for interventional tricuspidal clipping and standard monitoring for this procedure including arterial and central venous line and transesophageal ultrasound. A cuirass for extrathoracal negative pressure ventilation is placed onto the chest but not switched on. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Negative Pressure Ventilation, Right Ventricular Dysfunction, Right Ventricular Failure
- What is being tested?
- Negative Pressure Ventilation
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2024to 1 Sep 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients for tricuspidal clipping without an exclusion criterium
Who may be able to join
- patients planned for tricuspidal clipping
Who cannot join
- ventilatory of hemodynamic instability
- fitting of cuirass not possible
- unavailability of examiner
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinikum Karlsburg, Klinik für Anästhesiologie
Karlsburg, Mecklenburg-Vorpommern, 17495
About this study
Official title: Effects of Negative Pressure Ventilation on Right Ventricular Function in Cardiological Patients With Reduced Right Ventricular Function.
Patients receives induction of general anesthesia for interventional tricuspidal clipping and standard monitoring for this procedure including arterial and central venous line and transesophageal ultrasound. A cuirass for extrathoracal negative pressure ventilation is placed onto the chest but not switched on. During usual positive pressure ventilation a ventilatory, a hemodynamic and a 3D full volume ultrasounddataset of the right and left ventricle is recorded and severity of tricuspidal regurgitation examined. Afterwards negative pressure ventilation is started and positive pressure ventilation reduced as far as possible without reduction of tidal volumes. The same dataset of ventilation, hemodynamics and ultrasound is collected again during negative pressure ventilation. Afterwards the cuirass gets removed, study finished and everything proceeds as during standard procedure.
- Being tested
- Negative Pressure Ventilation
- Medical subject headings
- Ventricular Dysfunction, Right, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative Pressure VentilationDevice
Substitution of positive pressure ventilation by negative pressure ventilation
What is being measured
The primary outcome is the main question the study is designed to answer.
stroke volume index
transesophageal ultrasound measurement
Measured: 1 minute
Secondary outcomes (20)
RVEF
transesophageal ultrasound measurement
Measured: 1 minute
LVEF
transesophageal ultrasound measurement
Measured: 1 minute
volumes of chambers
transesophageal ultrasound measurement
Measured: 1 minute
strain
transesophageal ultrasound measurement
Measured: 1 minute
VC
transesophageal ultrasound measurement
Measured: 1 minute
PISA
transesophageal ultrasound measurement
Measured: 1 minute
EROA
transesophageal ultrasound measurement
Measured: 1 minute
area of regurgitation of tricuspid valve
transesophageal ultrasound measurement
Measured: 1 minute
arterial blood pressures
hemodynamic measurements
Measured: 1 minute
venous blood pressures
hemodynamic measurements
Measured: 1 minute
pulmonal blood pressures
hemodynamic measurements
Measured: 1 minute
heart frequency
hemodynamic measurements
Measured: 1 minute
tidal volume
ventilatory measurements
Measured: 1 minute
minute volume
ventilatory measurements
Measured: 1 minute
breathing rate
ventilatory measurements
Measured: 1 minute
etCO2
ventilatory measurements
Measured: 1 minute
pO2 in the blood
blood gases
Measured: 1 minute
pCO2 in the blood
blood gases
Measured: 1 minute
Laktat
blood gases
Measured: 1 minute
cerebral oximetry
NIRS
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Negative Pressure VentilationStudies 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
- Other
- Time perspective
- Other
- 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
- NCT06572072
- Sponsor's protocol ID
- KAIKB-2024_1
- Status last verified
- Aug 2024
- First submitted
- 7 Aug 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Negative Pressure Ventilation on Right Ventricular Function in Cardiological Patients With Reduced Right Ventricular Function.
- ClinicalTrials.gov ID
- NCT06572072
- Acronym / sponsor ID
- KAIKB-2024_1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Karlsburg HospitalUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 26 Aug 2024 (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.
Patients receives induction of general anesthesia for interventional tricuspidal clipping and standard monitoring for this procedure including arterial and central venous line and transesophageal ultrasound. A cuirass for extrathoracal negative pressure ventilation is placed onto the chest but not switched on. During usual positive pressure ventilation a ventilatory, a hemodynamic and a 3D full volume ultrasounddataset of the right and left ventricle is recorded and severity of tricuspidal regurgitation examined. Afterwards negative pressure ventilation is started and positive pressure ventilation reduced as far as possible without reduction of tidal volumes. The same dataset of ventilation, hemodynamics and ultrasound is collected again during negative pressure ventilation. Afterwards the cuirass gets removed, study finished and everything proceeds as during standard procedure.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients for tricuspidal clipping without an exclusion criterium
Key inclusion criteria (1 listed)
- patients planned for tricuspidal clipping
Key exclusion criteria (3 listed)
- ventilatory of hemodynamic instability
- fitting of cuirass not possible
- unavailability of examiner
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Negative Pressure VentilationSubstitution of positive pressure ventilation by negative pressure ventilation | Device | – |
Primary outcome
stroke volume index
Time frame: 1 minute
transesophageal ultrasound measurement
20 secondary outcomes
RVEF
Time frame: 1 minute
LVEF
Time frame: 1 minute
volumes of chambers
Time frame: 1 minute
strain
Time frame: 1 minute
VC
Time frame: 1 minute
PISA
Time frame: 1 minute
EROA
Time frame: 1 minute
area of regurgitation of tricuspid valve
Time frame: 1 minute
arterial blood pressures
Time frame: 1 minute
venous blood pressures
Time frame: 1 minute
pulmonal blood pressures
Time frame: 1 minute
heart frequency
Time frame: 1 minute
tidal volume
Time frame: 1 minute
minute volume
Time frame: 1 minute
breathing rate
Time frame: 1 minute
etCO2
Time frame: 1 minute
pO2 in the blood
Time frame: 1 minute
pCO2 in the blood
Time frame: 1 minute
Laktat
Time frame: 1 minute
cerebral oximetry
Time frame: 1 minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Negative Pressure Ventilation and Right Ventricular Dysfunction, 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 3 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 26 Aug 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stroke volume index (time frame: 1 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2024.