Clinical trial NCT03640741: Changes in Cerebral Oxygenation Studies During Laparoscopy Procedure
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Increase in Intra-abdominal Pressure
Increase in Intracranial Pressure (ICP)
Laparoscopy
Cerebral Perfusion and Oxygenation
Keywords: intra-abdominal pressure
intra-cerebral pressure
laparoscopy
brain perfusion
brain oxygenation
time-resolved near infrared spectroscopy
Lead sponsor: Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences
Sponsor class: OTHER
Collaborators: name: Medical University of Lublin
First posted: 2018-08-21
Enrollment: 17
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients of Gynecological Surgery Clinic

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.

Eligibility criteria: Inclusion Criteria:

* laparoscopic procedure

Exclusion Criteria:

* no consent

Primary outcomes:
measure: Distribution of time of flight of photons
timeFrame: 90 minutes (typically)
Secondary outcomes:
measure: Cerebral oxygenation
timeFrame: 90 minutes (typically)
measure: Fluctuations of changes in Hb and HbO2 concentrations
timeFrame: 90 minutes (typically)
Other outcomes:
Locations:
Study officials:
affiliation: Nalecz Institute of Biocybernetics and Biomedical Engineering
name: Adam Liebert, Prof
role: STUDY_CHAIR
References:
citation: Bloomfield GL, Ridings PC, Blocher CR, Marmarou A, Sugerman HJ. Effects of increased intra-abdominal pressure upon intracranial and cerebral perfusion pressure before and after volume expansion. J Trauma. 1996 Jun;40(6):936-41; discussion 941-3. doi: 10.1097/00005373-199606000-00012.
citation: Deeren DH, Dits H, Malbrain ML. Correlation between intra-abdominal and intracranial pressure in nontraumatic brain injury. Intensive Care Med. 2005 Nov;31(11):1577-81. doi: 10.1007/s00134-005-2802-2. Epub 2005 Sep 29.
citation: Kacprzak M, Liebert A, Staszkiewicz W, Gabrusiewicz A, Sawosz P, Madycki G, Maniewski R. Application of a time-resolved optical brain imager for monitoring cerebral oxygenation during carotid surgery. J Biomed Opt. 2012 Jan;17(1):016002. doi: 10.1117/1.JBO.17.1.016002.