Changes in Cerebral Oxygenation Studies During Laparoscopy Procedure

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

Study Overview

• Status: Completed
• Conditions: Laparoscopy; Increase in Intra-abdominal Pressure; Increase in Intracranial Pressure (ICP); Cerebral Perfusion and Oxygenation
• Intervention / Treatment: Procedure: Laparoscopy

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 Type: Observational
• Enrollment (Actual): 17

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Patients of Gynecological Surgery Clinic

Description

Inclusion Criteria:

• laparoscopic procedure

Exclusion Criteria:

• no consent

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Laparoscopy; The group consists of patients who undergoes laparoscopy procedure during which changes in cerebral oxygenation are estimated.	Procedure: Laparoscopy; The studies are carried out on patients who undergoes gynecological procedure that involves laparoscopy.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences
• Collaborators: Medical University of Lublin
• Investigators: Study Chair: Adam Liebert, Prof, Nalecz Institute of Biocybernetics and Biomedical Engineering

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2016
• Primary Completion (Actual): July 25, 2016
• Study Completion (Actual): December 18, 2017

Study Registration Dates

• First Submitted: July 17, 2018
• First Submitted That Met QC Criteria: August 20, 2018
• First Posted (Actual): August 21, 2018

Study Record Updates

• Last Update Posted (Actual): August 21, 2018
• Last Update Submitted That Met QC Criteria: August 20, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: laparoscopy; intra-abdominal pressure; brain perfusion; brain oxygenation; intra-cerebral pressure; time-resolved near infrared spectroscopy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hypertension
• Other Study ID Numbers: IAP_UMLub_GBox

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No