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Clinical Trials/NCT03640741
NCT03640741
Completed
Not Applicable

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

Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences0 sites17 target enrollmentJuly 11, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Increase in Intra-abdominal Pressure
Sponsor
Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences
Enrollment
17
Primary Endpoint
Distribution of time of flight of photons
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 11, 2016
End Date
December 18, 2017
Last Updated
7 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • laparoscopic procedure

Exclusion Criteria

  • no consent

Outcomes

Primary Outcomes

Distribution of time of flight of photons

Time Frame: 90 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 Outcomes

  • Cerebral oxygenation(90 minutes (typically))
  • Fluctuations of changes in Hb and HbO2 concentrations(90 minutes (typically))

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