Changes in Cerebral Oxygenation Studies During Laparoscopy Procedure

NCT ID: NCT03640741

Last Updated: 2018-08-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 17 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-07-11
• Study Completion Date: 2017-12-18

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.

Conditions

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

Laparoscopy

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

Laparoscopy

Intervention Type: PROCEDURE

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

Interventions

Laparoscopy

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• laparoscopic procedure

Exclusion Criteria

• no consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Lublin

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adam Liebert, Prof

Role: STUDY_CHAIR

Nalecz Institute of Biocybernetics and Biomedical Engineering

References

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.

Reference Type: BACKGROUND

PMID: 8656480 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16193329 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22352652 (View on PubMed)

Other Identifiers

IAP_UMLub_GBox

Identifier Type: -

Identifier Source: org_study_id