Early diagnosis of right ventricular dysfunction in high-risk cardiac surgery patients – a pilot study
| ISRCTN | ISRCTN12014278 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12014278 |
| Protocol/serial number | 147/26 S-IV Grant |
| Sponsor | General University Hospital in Prague |
| Funders | Všeobecná Fakultní Nemocnice v Praze, Ministerstvo Zdravotnictví Ceské Republiky |
- Submission date
- 16/10/2026
- Registration date
- 04/11/2026
- Last edited
- 04/11/2026
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
During heart surgery under general anaesthesia, doctors routinely use a thin catheter placed into the pulmonary artery (the blood vessel leading from the heart to the lungs) to monitor how well the heart works. A newer version, the Swan-Ganz IQ catheter, has an additional sensor that also records pressure in the right ventricle (the right-hand pumping chamber of the heart). Very little is known about how well this works in everyday practice. This pilot study aims to find out whether the catheter can display good-quality pressure curves from the right ventricle and the pulmonary artery at the same time in patients whose right ventricle is not working well, and whether changes in these curves could help detect problems with the right side of the heart early.
Who can participate?
Adults over 18 years of age who are scheduled for heart surgery, in whom a pulmonary artery catheter is needed anyway, and whose right ventricle function has been shown to be reduced by ultrasound of the heart or by cardiac catheterisation. Patients cannot take part if the catheter cannot be used safely (for example, a blood clot in the right-hand chambers of the heart or an active infection of the tricuspid valve) or if they cannot give informed consent.
What does the study involve?
After signing the consent form, 25 patients will be included. After they are put to sleep for their operation, the Swan-Ganz IQ catheter will be placed in the usual way and connected to a monitor. The monitor records pressures and other heart measurements, including the oxygen level in mixed venous blood. Monitoring continues after the operation, usually for 48 to 72 hours. Blood lactate is measured only from blood samples taken as part of routine care; no extra blood samples are needed. All patients receive the same procedure; there is no comparison group. The information collected is used to judge whether the catheter works as intended and whether it is associated with changes in the oxygen level and blood lactate. Any complications are recorded.
What are the possible benefits and risks of participating?
The catheter is used in the same way as a standard pulmonary artery catheter, so no additional risks beyond those of a standard catheter are expected. Known possible complications of such catheters include heart rhythm disturbances and, very rarely, injury to the heart. There is no direct benefit expected for participants; the results may help improve monitoring of future patients.
Where is the study run from?
Department of Anaesthesiology, Resuscitation and Intensive Medicine, General University Hospital in Prague (Czech Republic)
When is the study starting and how long is it expected to run for?
January 2027 to July 2027
Who is funding the study?
General University Hospital in Prague and the Ministry of Health of the Czech Republic (Czech Republic)
Who is the main contact?
Dr Jan Kunstýř, jan.kunstyr@vfn.cz
Contact information
Principal investigator
General University Hospital in Prague, Department of Anaesthesiology, Resuscitation and Intensive Medicine, U Nemocnice 499/2
Prague
12808
Czech Republic
 ORCID ID |
0000-0001-8119-5927 |
|---|---|
| Phone | +420 224962666 |
| pavel.michalek@vfn.cz |
Public, Scientific
General University Hospital in Prague, Department of Anaesthesiology, Resuscitation and Intensive Medicine, U Nemocnice 499/2
Prague
12808
Czech Republic
| ORCID ID |
0000-0002-3659-7764 |
|---|---|
| Phone | +420 224962733 |
| jan.kunstyr@vfn.cz |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | N/A: single arm study |
| Masking | Open (masking not used) |
| Control | Uncontrolled |
| Assignment | Single |
| Purpose | Device feasibility |
| Scientific title | Simultaneous right ventricular and pulmonary artery pressure waveform monitoring with the Swan-Ganz IQ catheter in adult cardiac surgery patients with right ventricular dysfunction: a single-centre, single-arm feasibility pilot study |
| Study objectives | 1. To assess the technical feasibility of obtaining an adequate right ventricular (RV) pressure waveform together with a pulmonary artery waveform using the Swan-Ganz IQ catheter in cardiac surgery patients with RV dysfunction 2. To explore how changes in the RV pressure waveform relate to mixed venous oxygen saturation (SvO₂) and lactate 3. To record technical and clinical complications of catheter use |
| Ethics approval(s) |
Approved 17/09/2026, Ethics Committee of the General University Hospital in Prague (Na Bojišti 1, Praha, 12808, Czech Republic; +420 224964131; eticka.komise@vfn.cz), ref: 147/26 S-IV Grant |
| Health condition(s) or problem(s) studied | Right ventricular dysfunction in patients undergoing cardiac surgery |
| Intervention | Twenty-five adult patients with right ventricular dysfunction who are scheduled for cardiac surgery and in whom a pulmonary artery catheter is clinically indicated will be enrolled. After induction of general anaesthesia, a Swan-Ganz IQ catheter will be inserted through an introducer sheath into the pulmonary artery using the standard technique and connected to the HemoSphere Alta monitor. In patients undergoing pulmonary endarterectomy, the catheter will be positioned in a pulmonary artery branch while maintaining an interpretable RV pressure waveform; in other patients it will be advanced to the wedge position. RV pressures, RV cardiac output and index, RV end-diastolic pressure, the difference between early and late diastolic RV pressure, pulmonary artery pressures, SvO₂ and the Global Hypoperfusion Index will be recorded continuously. There is no control group and no randomisation. Data are recorded from catheter insertion until catheter removal (routinely at least 48 hours after surgery), for a maximum of 72 hours per participant. Until its purchase by the hospital is completed, the HemoSphere Alta monitor is provided to the hospital on loan by the device supplier under a loan agreement; Swan-Ganz IQ catheters are purchased by the hospital. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Swan-Ganz IQ pulmonary artery catheter (Edwards Lifesciences, model AIQSGF8) with HemoSphere Alta monitor |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 31/07/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 120 Years |
| Sex | All |
| Target sample size at registration | 25 |
| Key inclusion criteria | 1. Age over 18 years 2. Signed informed consent 3. Planned cardiac surgical procedure 4. Clinical indication for pulmonary artery catheter insertion 5. Right ventricular dysfunction confirmed by echocardiography or cardiac catheterisation |
| Key exclusion criteria | 1. Contraindication to pulmonary artery catheter insertion 2. Thrombus in the right ventricle or right atrium 3. Active tricuspid valve endocarditis 4. Inability to obtain informed consent |
| Date of first enrolment | 04/01/2027 |
| Date of final enrolment | 30/06/2027 |
Locations
Countries of recruitment
- Czech Republic
Study participating centres
Prague
12808
Czech Republic
Prague
12808
Czech Republic
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1.0 | 01/09/2026 | 19/10/2026 | No | No |
Additional files
- 50484 Study_Protocol_Swan-Ganz_IQ AJ v1.0 01Sep2026.pdf
- Protocol file
Editorial Notes
19/10/2026: Trial's existence confirmed by Ethics Committee of the General University Hospital in Prague.
