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Validation of a new PCO2 measurement catheter

Completed
Conditions
splanchnic ischemia
10018031
Registration Number
NL-OMON34918
Lead Sponsor
Medisch Spectrum Twente
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
200
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

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Air tonometry: a. precision and bias of PCO2 measurement<br /><br>Fluid tonometry: a. correction factors for 10, 20, and 30 minutes<br /><br>equilibration time, b. precision and bias calculation for each dwell time<br /><br>Patient study: measurement errors with use of the tonocap in patients </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>1.Blood gas analyser: correction factor for PCO2 measurement from saline.<br /><br>2.Patient study:<br /><br>a.The handling characteristics for placement in the small bowel<br /><br>b.time needed for small bowel placement during fluoroscopy<br /><br>c.handling characteristics during 24 hour measurement<br /><br>d.patient (in)convenience during 24 hour measurement</p><br>
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