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
- Pericardial disorders
- Respiratory tract neoplasms
- Respiratory tract therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The feasibility to introduce a soft tissue expander trough a mini-thoracotomy.
The feasibility to inflate and position the soft tissue expander in the human
hemithorax.
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.
• The occurrence of possible complications due to tissue expander implantation.
• The occurrence of arrhytmias due to tissue expander implantation.
• 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 pneumonectomy. While doing this we will evaluate amongst
others the ease of implantability, the geometrical fit and the hemodynamical
and respiratory response once implanted.
Study burden and risks
Besides a Schwann Ganz catheter implantation for hemodynamic monitoring during
the procedure, patients participating in our study will receive standard
patient care (e.i. tailored clinical care without additional tests or
examinations). Due to the fact that patients participating in our study are
scheduled to undergo a pneumonectomy (e.i. removal of an entire lung), the risk
on tissue damage due to our soft tissue expander is neglectible. Besides a
Schwann Ganz catheter implantation for hemodynamic monitoring during the
procedure, patients participating in our study will receive standard patient
care (e.i. tailored clinical care without additional tests or examinations).
Due to the fact that patients participating in our study are scheduled to
undergo a pneumonectomy (e.i. removal of an entire lung), the risk on tissue
damage due to our soft tissue expander is neglectible. Besides a Schwann Ganz
catheter implantation for hemodynamic monitoring during the procedure, patients
participating in our study will receive standard patient care (e.i. tailored
clinical care without additional tests or examinations). Due to the fact that
patients participating in our study are scheduled to undergo a pneumonectomy
(e.i. removal of an entire lung), the risk on tissue damage due to our soft
tissue expander is neglectible.
P.Debyelaan 25
Maastricht 6229HX
NL
P.Debyelaan 25
Maastricht 6229HX
NL
Listed location countries
Age
Inclusion criteria
• Age >= 18 <= 70 years
• Stage I or II Non Small Cell Lungcarcinoma (NSCLC) requiring pneumonectomy due to central localization of malignancy
• Forced expiratory volume in one second (FEV1) >2 L (or >=80 percent predicted)
• Dutch speaking
• Informed consent
Exclusion criteria
• Significant coronary or cardiac valvular 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 | NL39095.068.11 |