In our current study we would like to evaluate a newly developed surgical platform for minimal invasive cardiothoracic surgery: the soft tissue expander. Main objective of the study is to determine the feasibility of creating a trans tissue expander…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
- Respiratory tract therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) The feasibility to introduce a soft tissue expander trough a
mini-thoracotomy.
2) The feasibility to inflate and position the soft tissue expander in the
human hemithorax.
3) The feasibility to create a trans-soft tissue expander approach to the human
pericardium and to quantitatively assess the
working space on the pericardium.
Secondary outcome
* The hemodynamic response after implantation and optimal positioning of the
soft tissue expander.
o Change in heartrate
o Change in CVP
o Change in right ventricular pressure
o Change in PAP
o Change in CI
o Change in Arterial blood pressure
* The ventilatory response after implantation and optimal positioning of the
soft tissue expander while maintaining similar tidal volumes and ventilation
frequencies.
o Change in pulmonary airway pressure (maximum and mean)
o Change in carbondioxide end-tidal-pressure
o Change in lung compliance
* The respiratory response after implantation and optimal positioning of the
soft tissue expander.
o Change in arterial blood oxygenation
o Change in arterial blood pCO2 and pO2
* Evaluating whether the optimal length size as obtained on CT-scan corresponds
with the ideal length size in humans.
o The occurrence of possible complications due to tissue expander implantation.
o The occurrence of arrhytmias due to tissue expander implantation.
o The occurrence of atelectasis and the insufflation pressure necessary to
re-expand the collapsed lung after removal of the soft tissue expander.
Background summary
Key requirements in surgery in general, are access to, exposure of and
stability of the surgical target. Traditionally, cardiothoracic surgery is
still highly invasive being associated with significant risks and discomfort.
Although cardiologists offer decent minimal invasive alternatives to invasive
coronary artery bypass grafting, the majority of patients undergoing
percutaneous coronary intervention eventually have to undergo invasive bypass
surgery in the long run. Even though there are several options available
facilitating minimal invasive cardiac surgery, each option is associated with
significant complications and hemodynamic and respiratory difficulties. In
order to overcome these problems a new surgical platform has been advocated.
This platform should allow access, visualisation, exposure and presentation of
the surgical target without interfering with organ function. Only whenever
these requirements are met, minimal invasive cardiothoracic surgery can become
reality.
Study objective
In our current study we would like to evaluate a newly developed surgical
platform for minimal invasive cardiothoracic surgery: the soft tissue expander.
Main objective of the study is to determine the feasibility of creating a trans
tissue expander approach to the human pericardium and the mechanical stability
during physiological two lung ventilation.
Secondary objective of this study are the evaluation of hemodynamic and
respiratory response to device implantation, the occurrence of peri-operative
complications and the occurrence of cardiac rhythm disorders due to device
implantation.
Study design
prospective observational study without control group
During this study we will implant the soft-tissue-expander for a short periode
of time during a thoracoscopische atrial fibrillation (AF) ablation. While
doing this we will evaluate amongst others the ease of implantability, the
geometrical fit and the hemodynamical and respiratory response once implanted.
Intervention
"Spacemaker" facilitated thoracoscopy
Study burden and risks
Individuals participating in this research are exposed to minimal adjuvant
risks, apart from the risks involved in thoracoscopic atrial fibrillation
ablation. The usage of the "Spacemaker" has been extensively studied in
laboratory animals. These studies showed that the use of the "Spacemaker" in
the chestcage is deemed safe and feasible. Furthermore, use of the "Spacemaker"
was not associated with any significant damage to the lung tissue after 4 weeks
of recovery.
P.Debyelaan 25
Maastricht 6229HX
NL
P.Debyelaan 25
Maastricht 6229HX
NL
Listed location countries
Age
Inclusion criteria
* Age * 18 * 70 years
* Dutch speaking
* Patients undergoing thoracoscopic atrial fibrillation surgery
* Informed consent
Exclusion criteria
* Significant cardiac or respiratory comorbidity as assessed by cardiologist or anesthesiologist
* History of tuberculosis (TBC) or pleuritis
* Prior thoracic trauma
* Prior thoracic surgery
* Known allergy for poly urethanes of polyvinyl chloride
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL55718.068.15 |
| Other | nummer aangevraagd - momenteel in behandeling bij trialregister.nl |