To compare oesophageal acid exposure time measured with glass, ISFET and antimony electrodes in patients with reflux symptoms and basic pH electrode characteristics, response time, sensitivity and drift between the 3 types of pH electrodes.
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Acid exposure time (percentage of time with a pH below 4 at 5 cm above the
upper border of the lower oesophageal sphincter)
Secondary outcome
The numbers reflux episodes detected by impedance monitoring subdivided into
acid, weakly acidic and weakly alkaline reflux episodes using pH measurement.
The characteristics of the different pH electrodes (response time, sensitivity
and drift)
Background summary
The acid exposure time is an important parameter that is assessed during 24-h
pH-impedance monitoring in patients with gastro-oesophageal reflux disease
(GORD). It is expressed as the percentage of time with a pH below the threshold
of 4 in the oesophagus at 5 cm above the upper margin of the lower oesophageal
sphincter (LOS). Several types of pH electrodes (glass, antimony and ISFET
electrodes) are currently commercially available. It is not known whether these
different types of pH electrodes will result in different acid exposure times
in patients with symptoms of reflux disease.
Study objective
To compare oesophageal acid exposure time measured with glass, ISFET and
antimony electrodes in patients with reflux symptoms and basic pH electrode
characteristics, response time, sensitivity and drift between the 3 types of pH
electrodes.
Study design
This study consists of two parts: an in vitro and an in vivo study. In the in
vitro study we will assess the basic pH electrode characteristics of each type
of pH electrode. For the in vivo study we will simultaneously record
oesophageal pH with three different pH electrodes in each patient during an
ambulatory 24h pH-impedance monitoring.
Study burden and risks
After placement, the three catheters cause no additional risk or inconvenience
compared to the regular measurement with one catheter. The total diameter of
the three catheters is comparable with the diameter of the catheters used
during ambulatory pH-manometry in patients with non-cardiac chest pain.
Heidelberglaan 100
3584CX Utrecht
Nederland
Heidelberglaan 100
3584CX Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
Reflux symptoms
Age > 18y
Informed consent
Exclusion criteria
Age < 18y
Absence of Informed consent
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 | NL22155.041.08 |