Primary Objective: for each new catheter design: in-vitro establishment of time-dependent correction factors for saline-use and establish the accuracy of CO2 measurement with the capnograph. In-vivo: establish the feasibility and measurement errors…
ID
Source
Brief title
Condition
- Gastrointestinal vascular conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Air tonometry: a. precision and bias of PCO2 measurement
Fluid tonometry: a. correction factors for 10, 20, and 30 minutes
equilibration time, b. precision and bias calculation for each dwell time
Patient study: measurement errors with use of the tonocap in patients
Secondary outcome
1.Blood gas analyser: correction factor for PCO2 measurement from saline.
2.Patient study:
a.The handling characteristics for placement in the small bowel
b.time needed for small bowel placement during fluoroscopy
c.handling characteristics during 24 hour measurement
d.patient (in)convenience during 24 hour measurement
Background summary
Gastrointestinal ischemia is a notoriously difficult diagnosis. Both
diagnostics on vessel anatomy and a functional test to show ischemia in the GI
tract are necessary. Currently only gastrointestinal PCO2 tonometry has been
validated as accurate measure of gastric ansd small bowel ischemia. In this
test a balloon-tipped catheteris placed via te nasal route in tghe stomach or
small bowel. By injection and aspiration of fluid or air the luminal PCO2 can
be measured. With air measurement the catheter is connected to a special
capnograph, with fluid tonometry, the aspirated fluid is measured in a standard
blood gas analyser. Ischemia is characterised by local PCO2 accumulation.
Currently, this is the only validated test for detection of GI ischemia.
However, bnecause the test is both time-consuming and relatively complicated it
used (too) infrequently.
In Enschede we have experience in > 1000 patients with this test. The
diagnostic accuracy is high, and studies with sufficient follow-up have shown
its clinical relevance for patient selection for surgery, urgency for vascular
procedures and follow-up. Altough there is increasing research to alternative
functioanl test, all currently available alternatives are either unvalidated or
less accurate.
Because the current firm that markets the catheters and capnographs has stopped
production we were urgently llooking for an alternative because stopping these
measurements would severely limit our clinical decision making process.
We have therefore contacted the firm that has produced these catheters for the
last decade for a solution. They agreed to resume production, with the intent
to get CE certification, and then market the catheter. The current study has
therefore two goals: 1) to establish data needed for a CE registration and 2)
to be able to continue this invaluable diagnostic tool in patients suspected
for GI-ischemia.
Study objective
Primary Objective: for each new catheter design: in-vitro establishment of
time-dependent correction factors for saline-use and establish the accuracy of
CO2 measurement with the capnograph. In-vivo: establish the feasibility and
measurement errors in subjects analysed for GI-ischemia detection.
Secondary Objective(s): (1) ease-of-use of the catheters (time needed for small
bowel placement), handling characteristics and patient (in)convenience during
24 hour measurement. Areas for improvement for catheter design.
Study design
observational study
Study burden and risks
not applicable: the standard work-up will be performed, only the catheter will
differ
Ariënsplein1
7511 RX Enschede
NL
Ariënsplein1
7511 RX Enschede
NL
Listed location countries
Age
Inclusion criteria
patienst referred for potential gastrointestinal ischemia (postprandial pain, weight loss or diarrhea, otherwise unexplained, or associated with vascular stenoses)
Exclusion criteria
Age < 18 years,
Poor clinical condition which would make the diagnosis of GI ischemia clinically unimportant.
End-stage liver disease
End-stage cardiopulmonary disease.
Hemorrhagic disorders
Severe esophageal inflammation
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 | NL31471.044.10 |