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Changes in Cerebral Oxygenation Studies During Laparoscopy Procedure

Changes in Cerebral Oxygenation Studies Carried Out With the Use of Non-invasive Time-resolved Near-infrared Spectroscopy Device in Patients Undergoing Laparoscopy Procedure

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03640741
Enrollment
17
Registered
2018-08-21
Start date
2016-07-11
Completion date
2017-12-18
Last updated
2018-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Perfusion and Oxygenation, Increase in Intra-abdominal Pressure, Increase in Intracranial Pressure (ICP), Laparoscopy

Keywords

intra-abdominal pressure, intra-cerebral pressure, laparoscopy, brain perfusion, brain oxygenation, time-resolved near infrared spectroscopy

Brief summary

The motivation results from the fact, that an intra-abdominal pressure is correlated with cerebral perfusion, in a mechanism of reducing venous outflow. Moreover, elevated intra-abdominal pressure leads to increase in intracranial pressure and decrease of cerebral perfusion pressure. The main aim of the study was to investigate an influence of increase in intra-abdominal pressure on cerebral oxygenation measured with the use of non-invasive optical technique.

Detailed description

The investigators applied time resolved near infrared spectroscopy device in order to estimate changes in hemoglobin concentration in a brain during gynecological procedure that involves laparoscopy. The optodes were positioned on a forehead on left and right hemisphere. The measurements were carried out during whole medical procedure, including anesthesia, start and stop of insufflation of abdominal cavity with carbon dioxide (CO2), surgical procedure, release of CO2 and waking up a patient. In those studies the special emphasis was put on a period of insufflation of abdominal cavity with CO2.

Interventions

PROCEDURELaparoscopy

The studies are carried out on patients who undergoes gynecological procedure that involves laparoscopy.

Sponsors

Medical University of Lublin
CollaboratorOTHER
Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* laparoscopic procedure

Exclusion criteria

* no consent

Design outcomes

Primary

MeasureTime frameDescription
Distribution of time of flight of photons90 minutes (typically)Distribution of time of flight of photons measured at 2 wavelengths, 690 nm and 830 nm and at 2 spots on a forehead

Secondary

MeasureTime frameDescription
Cerebral oxygenation90 minutes (typically)Changes oxygenated (HbO2) and deoxygenated (Hb) hemoglobin concentrations expressed in micro Molars
Fluctuations of changes in Hb and HbO2 concentrations90 minutes (typically)Fourier transform of changes in concentrations of Hb and HbO2

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026