Changes in Cerebral Oxygenation Studies During Laparoscopy Procedure

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Procedure: Laparoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: laparoscopic procedure Exclusion Criteria: no consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Laparoscopy<br>The group consists of patients who undergoes laparoscopy procedure during which changes in cerebral oxygenation are estimated. | Procedure: Laparoscopy<br>* The studies are carried out on patients who undergoes gynecological procedure that involves laparoscopy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of time of flight of photons | Distribution of time of flight of photons measured at 2 wavelengths, 690 nm and 830 nm and at 2 spots on a forehead | 90 minutes (typically) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral oxygenation | Changes oxygenated (HbO2) and deoxygenated (Hb) hemoglobin concentrations expressed in micro Molars | 90 minutes (typically) | 
| Fluctuations of changes in Hb and HbO2 concentrations | Fourier transform of changes in concentrations of Hb and HbO2 | 90 minutes (typically) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intra-abdominal pressure, intra-cerebral pressure, laparoscopy, brain perfusion, brain oxygenation, time-resolved near infrared spectroscopy