The primary objective of this study is to test safety and performance of the APD Perfusion Measurement Catheter & Monitor for the measurement of gut perfusion in humans. The secondary objectives of this study are to assess the normal values for…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
gut perfusion
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
A device developed to determine the intestinal mucosa blood flow, measured in
ml / min
Secondary outcome
None.
Background summary
The APD Perfusion Measurement Catheter is intended to provide non-invasive
measurement of gut perfusion, which can be used as an indication of septic and
hypovolemic shock. The catheter also measures intra-abdomional pressure.
Study objective
The primary objective of this study is to test safety and performance of the
APD Perfusion Measurement Catheter & Monitor for the measurement of gut
perfusion in humans.
The secondary objectives of this study are to assess the normal values for
superior mesenteric artery flow in anaesthethised surgical patients.
Study design
The APD Perfusion Measurement study is a prospective, single-center pilot
study, enrolling 5 patients.
The study is to be carried out in a single centre, Zaans medisch Centrum
Study burden and risks
Prior to the procedure a Radiologist to perform transcutaneous
Doppler-Echography to measure the superior mesenteric flow.
Patient is prepared for aortic vascular surgery, as per institutional
protocol. After opening of the abdomen a Gastroenterologist is to perform
gastroduodenoscopy and to place the catheter.
A Doppler flow probe is placed on a branch of the mesenteric artery. The
mesenteric artery flow, as measured by the Doppler flow probe and gut
perfusion, as measured by the APD Catheter and Monitor are recorded for 15
minutes.
Post-procedural evaluation of the correlation between the gut perfusion, as
indicated by the APD Perfusion Measurement & Monitor and the mesenteric artery
flow.
The associated risks proposed in this study, are similar to risks posed by use
of endoscopic and duodenal feeding procedures. These risks include bleeding,
perforation and aspiration. The incident rate of perforation in
gastroduodenoscopy is 0.029% for non-interventional procedures (Merchea A, et
al., 2010).
The incident rates associated with the delivery and use of the APD Perfusion
Measurement Catheter, are not anticipated to be greater than conventional
gastro-duodenoscopic procedures. Specifically, risks to the patient are
minimized due to the use of standard medical grade materials, extensive
pre-clinical evaluation including in vitro bench testing and animal studies and
the well established, standard nature of the endoscopic and duodenal feeding
procedures used.
Zur Wetterwarte 50, House 302
01109 Dresden
DE
Zur Wetterwarte 50, House 302
01109 Dresden
DE
Listed location countries
Age
Inclusion criteria
Patients for elective sugery for repair of infrarenal abdominal aneurysm
Exclusion criteria
ASA classification IV or V
Malignancy
Uncontrollable hypertension systolic > 240 mmHg or diastolic > 110 mmHg
Uncontrollable heart failure
Design
Recruitment
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 | NL37183.094.11 |