Changes in Cerebral Oxygenation Studies During Laparoscopy Procedure

Completed

• Conditions: Laparoscopy; Cerebral Perfusion and Oxygenation; Increase in Intra-abdominal Pressure; Increase in Intracranial Pressure (ICP)
• Interventions: Procedure: Laparoscopy

• Registration Number: NCT03640741
• Lead Sponsor: Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences

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.

Study Timeline

• Study Start: 2016-07-11
• Primary Completion: 2016-07-25
• Study Completion: 2017-12-18
• Study First Submitted: 2018-07-17
• Status Verified: 2018-08
• Study First Submitted QC: 2018-08-20
• Last Update Submitted: 2018-08-20
• Study First Posted: 2018-08-21
• Last Update Posted: 2018-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 17

Inclusion Criteria

• laparoscopic procedure

Exclusion Criteria

• no consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Laparoscopy	Laparoscopy	The group consists of patients who undergoes laparoscopy procedure during which changes in cerebral oxygenation are estimated.

Primary Outcome Measures

Name	Time	Method
Distribution of time of flight of photons	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 Outcome Measures

Name	Time	Method
Cerebral oxygenation	90 minutes (typically)	Changes oxygenated (HbO2) and deoxygenated (Hb) hemoglobin concentrations expressed in micro Molars
Fluctuations of changes in Hb and HbO2 concentrations	90 minutes (typically)	Fourier transform of changes in concentrations of Hb and HbO2