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Completed

NCT Number: NCT03640741

Changes in Cerebral Oxygenation Studies During Laparoscopy Procedure

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • laparoscopic procedure

Exclusion criteria

  • no consent

Treatment and study plan

Laparoscopy

Procedure

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

Primary outcomes

  1. 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

  1. Cerebral oxygenation

    Time frame: 90 minutes (typically)

    Changes oxygenated (HbO2) and deoxygenated (Hb) hemoglobin concentrations expressed in micro Molars

  2. Fluctuations of changes in Hb and HbO2 concentrations

    Time frame: 90 minutes (typically)

    Fourier transform of changes in concentrations of Hb and HbO2

Sponsors and collaborators

Lead sponsor

Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences

Other

Collaborators

  • Medical University of Lublin

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Aug 21, 2018
Registry last updated
Aug 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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