The primary objective of this study is to determine the safety and feasibility of turbine-based insufflation, measured in terms of occurrence of adverse device effects and serious adverse device effects. The secondary objectives are to determine the…
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Health condition
geen specifieke aandoening, heeft betrekking op abdominale laparoscopische procedures
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The number and nature of (serious) adverse device effects related to the
turbine-based insufflator that occur during use.
Secondary outcome
- Determination of pressure stability throughout all procedures.
- Identification of events that impair insufflation pressure stability.
- Determination of the gas volume exchange required to keep insufflation
pressures stable, absolute and in relation to ventilation tidal volumes.
- Investigation of ventilator action and insufflator response in terms of
amplitude and temporal offset.
- Comparison between the insufflation pressure chosen by the surgeon and the
optimal pressure derived from endoscopic oscillometry.
- Evaluation of the applied pressure amplitudes and frequencies needed basing
on patient*s weight and size, in order to get reference values of the abdominal
cavity*s compliance [L/hPa] in humans.
- Evaluation of flows generated by the oscillation pressures applied for the
purpose of sizing measuring instruments (flowmeters).
- Evaluation of the range of frequencies used in oscillometry on patients* size
and weight for estimating the compliance.
- Comparison of pressure and flow time tracing both in ventilation and
insufflation to derive the static compliance of the respiratory system.
- Compensation of ventilation effects on pressure and flow signals. A
post-processing analysis of the acquired signals will be done in order to
filter out these effects and retain the information on the applied forced
oscillations.
- Optimization of endoscopic oscillometry in patients with different breathing
rates.
Background summary
Surgical workspace in minimal access surgery is created using an insufflation
device that pressurizes CO2 gas. The principle behind these devices has
remained unchanged for decades, and depends on the creation of a static
pressurized gas volume that is strongly affected by external pressures, and
vice versa exerts pressure onto the surrounding structures. As a consequence,
organ perfusion and venous return are reduced, high ventilation pressures are
required to compensate for the insufflation pressure and patients often report
postoperative pain following insufflation. Erasmus MC and Politecnico di Milano
have developed a new insufflator based on turbine technology, which allows very
stable pressures by allowing insufflation gas flow between the abdominal cavity
and a reservoir within the insufflator.
This first in-human-trial has the primary aim of evaluating safety and
feasibility of turbine-based insufflation in adults undergoing laparoscopic
surgery.
Study objective
The primary objective of this study is to determine the safety and feasibility
of turbine-based insufflation, measured in terms of occurrence of adverse
device effects and serious adverse device effects. The secondary objectives are
to determine the pressure stability performance during the procedures, as well
as the ability to measure abdominal compliance using endoscopic oscillometry
during initial insufflation.
Study design
This study is a prospective clinical safety and feasibility trial of the
turbine-based insufflator in intraperitoneal laparoscopy. In total, 12 patients
will be included and are planned for laparoscopy. At the start of each
procedure, oscillometric measurements will be done during initial insufflation
of the abdomen, after which the procedure will be performed at the insufflation
pressure chosen by the surgeon. The insufflator is monitored throughout the
procedure and checked for safety and feasibility. Any device-related events are
recorded. Besides, the conventional insufflator will be standby if needed.
Study burden and risks
Apart from containing informed consent prior to the study no additional contact
moments have been scheduled for the subject.
During surgery, the surgeon will use the turbine-based insufflator instead of
the conventional insufflator. At the beginning of surgery, the insufflation
pressure will be gradually increased, prolonging the operation with a few
minutes. No additional risks are expected, because of the minimum duration of
extra time needed.
Previous research in animals and in vitro models has shown no adverse device
effects. The risk of (S)ADEs is therefore estimated as low. The device complies
with technical standards, which limits the consequences of malfunctions. If the
device exceeds the threshold values, for example of pressure and temperature,
an alarm will warn the surgeon. Rapid action can be taken and, if necessary,
the surgeon can switch to a conventional insufflator that will be on standby at
all times during the surgical procedure, so that the procedure can be resumed
as fast as possible.
Wytemaweg 80
Rotterdam 3015CN
NL
Wytemaweg 80
Rotterdam 3015CN
NL
Listed location countries
Age
Inclusion criteria
- Adults (>=18 years old)
- Elective surgery
- Intraperitoneal laparoscopy
- Planned use of a main 12 mm trocar
Exclusion criteria
- Inability to contain the insufflation gas to the intraperitoneal space
- Pregnancy
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 | NL85402.078.23 |