To describe the human gastrointestinal microcirculation during gastrointestinal surgery under general anesthesia and to observe whether there is a correlation between bowel microcirculation and systemic hemodynamic parameters.
ID
Source
Brief title
Condition
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To describe human gastrointestinal microcirculation on both the serosal and
mucosal side of the bowel during gastrointestinal surgery under general
anesthesia. Main parameter: Microvascular perfusion is quantified using the
Microvascular Flow Index (MFI).
Secondary outcome
Perfused vessel density (PVD), proportion of perfused vessels (PPVs), en
heterogeneity of the microcirculation. To observe the possible correlation
between bowel microcirculation and systemic hemodynamic parameters. MFI, PVD,
PPV and indices of heterogeneity are compared between sides and to systemic
hemodynamic parameters such as blood pressure, and if accessible, cardiac
output (CO), stroke volume (SV) and stroke volume variation (SVV). These latter
parameters are automatically measured by the FloTrac*/Vigileo* and thus only
accessible when an arterial catheter is inserted.
Background summary
The interaction between macro and microcirculation remains uncertain.
Microvascular alterations can occur when systemic hemodynamic parameters are
within an acceptable range. Perfusion changes and microvascular alterations may
play an important role in anastomotic healing and the onset of anastomotic
leakage after gastrointestinal surgery. Nowadays, assessment of bowel perfusion
is macroscopically performed by the surgeon prior to anastomosis creation.
However, local oxygen delivery may still be compromised as little is known
about microcirculatory alterations of the bowel during colorectal surgery. Dark
Field (DF) imaging is a technique using a stroboscopic light-emitting diode
ring-based imaging modality incorporated in a hand-held device, which
illuminates an area of interest and provides high contrast dynamic images of
the microvasculature. DF-imaging enables to visualize the bowel*s
microcirculation.
Study objective
To describe the human gastrointestinal microcirculation during gastrointestinal
surgery under general anesthesia and to observe whether there is a correlation
between bowel microcirculation and systemic hemodynamic parameters.
Study design
A prospective, single center, observational, clinical, pilot study.
Study burden and risks
The extend of burden and risk associated with participation is negligible.
Using DF imaging on the bowel is a non-invasive technique requiring a minimal
amount of time as is described in the study procedure. Previous studies did not
show any safety concerns. Measuring will be performed under sterile conditions
and the occurrence of tissue damage is highly unlikely. Patients are under
general anesthesia and will thus not experience any inconvenience.
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Listed location countries
Age
Inclusion criteria
All patients aged >18 scheduled for elective, gastrointestinal surgery (as described above) with signed informed consent.
Exclusion criteria
Age <18 years;
Atrial fibrillation (because of possible interference with FloTrac*/Vigileo* cardiac output monitor);
Left ventricular ejection fraction *30%;
Serious pulmonary disease (resting pO2 <90% at room air);
Renal failure (clearance <30 ml/min as calculated using the Modification of Diet in Renal Disease formula);
Liver failure;
No signed informed consent.
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 | NL48332.100.14 |