Changes in Cerebral Oxygenation Studies During Laparoscopy Procedure

NCT03640741 | Completed

• 1 other identifier: IAP_UMLub_GBox
• Study Type: observational
• Target: 17
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Cerebral oxygenation

  90 minutes (typically)

• Fluctuations of changes in Hb and HbO2 concentrations

  90 minutes (typically)

Study Arms (1)

Laparoscopy

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

Procedure: Laparoscopy

Interventions

Laparoscopy PROCEDURE

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

Laparoscopy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The studies are carried out on the gynecological ward of Medical University of Lublin what results in the fact that females were studied only.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients of Gynecological Surgery Clinic

You may qualify if:

• laparoscopic procedure

You may not qualify if:

• no consent

Sponsors & Collaborators

• Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences: lead
• Medical University of Lublin: collaborator

Related 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. doi: 10.1097/00005373-199606000-00012.

  PMID: 8656480 BACKGROUND

• 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.

  PMID: 16193329 BACKGROUND

• 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.

  PMID: 22352652 BACKGROUND

MeSH Terms

Interventions

Laparoscopy

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Adam Liebert, Prof

  Nalecz Institute of Biocybernetics and Biomedical Engineering

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2018
• First Posted: August 21, 2018
• Study Start: July 11, 2016
• Primary Completion: July 25, 2016
• Study Completion: December 18, 2017
• Last Updated: August 21, 2018

Record last verified: 2018-08