To evaluate the tissue-oxygenation and microcirculation before, during and after application of artificial pneumoperitoneum/-thorax using Near Infrared Spectroscopy (NIRS) and Sidestream Dark Field Imaging (SDF) and validate the usefulness of theseā¦
ID
Source
Brief title
Condition
- Other condition
- Congenital and hereditary disorders NEC
- Breast therapeutic procedures
Synonym
Health condition
Operaties wegens met name conginitale hernia diafragmatica en slokdarmatresie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Tissue-oxygenation, measured by conventional methods and NIRS/SDF
Secondary outcome
Hormonal stress-respons to minimal access surgery (CO2 insufflation)
Background summary
Minimal access surgery has many advantages. Less trauma to body-tissues means
smaller scars and faster post-operative recovery. In neonates, CO2
pneumoperitoneum and pneumothorax have a major effect on hemodynamics. Acidosis
occurs, and measuring tissue-oxygenation is done by bloodgas analysis. The
intermittent sampling causes lacunae in the information about the oxygenation
of brain and other organs.
Whether less trauma to tissues leads to a decreased hormonal stress-respons is
unknown. Insufflation of CO2 might also be a stressor, but it's effect on
stress-hormone levels is unknown.
Study objective
To evaluate the tissue-oxygenation and microcirculation before, during and
after application of artificial pneumoperitoneum/-thorax using Near Infrared
Spectroscopy (NIRS) and Sidestream Dark Field Imaging (SDF) and validate the
usefulness of these techniques in monitoring neonates during Minimal Access
Surgery. This will result in follow-up studies where these measurements will be
used to make therapeutical interventions.
To compare the hormonal stress response during and after endoscopic surgery
with historic data we have from neonates undergoing the corresponding open
surgical procedures
Study design
Single-centre, non-randomized, observational study
Study burden and risks
All measurements will be done under anesthesia. Measurements are non-invasive,
no radiation is involved. A small quantity of blood will be collected for
determination of stress-hormone levels.
Postbus 2060
3000 CB Rotterdam
NL
Postbus 2060
3000 CB Rotterdam
NL
Listed location countries
Age
Inclusion criteria
All neonates 0-28 days of age
Endoscopic procedure, laparoscopy or thoracoscopy
Estimated duration of surgery more than 1 hour
Informed consent
Exclusion criteria
Inabilty to obtain informed consent from parents
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 | NL34637.078.10 |