Changes in Cerebral Oxygenation Studies During Laparoscopy Procedure

Laparoscopy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03640741
• Other study ID #: IAP_UMLub_GBox
• Status: Completed
• Start date: July 11, 2016
• Est. completion date: December 18, 2017

Study information

• Verified date: August 2018
• Source: Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 18, 2017
• Est. primary completion date: July 25, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• laparoscopic procedure

Exclusion Criteria:

• no consent

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Laparoscopy
The studies are carried out on patients who undergoes gynecological procedure that involves laparoscopy.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences	Medical University of Lublin

References & Publications (3)

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. — View 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. Epub 2005 Sep 29. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cerebral oxygenation	Changes oxygenated (HbO2) and deoxygenated (Hb) hemoglobin concentrations expressed in micro Molars	90 minutes (typically)
Secondary	Fluctuations of changes in Hb and HbO2 concentrations	Fourier transform of changes in concentrations of Hb and HbO2	90 minutes (typically)