Increase in Intra-abdominal PressureNCT03640741
Changes in Cerebral Oxygenation Studies During Laparoscopy Procedure
An observational study of Increase in Intra-abdominal Pressure and Increase in Intracranial Pressure (ICP), run by Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Increase in Intra-abdominal Pressure, Increase in Intracranial Pressure (ICP), Laparoscopy
- What is being tested?
- Laparoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- 11 Jul 2016to 18 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients of Gynecological Surgery Clinic
Who may be able to join
- laparoscopic procedure
Who cannot join
- no consent
About this study
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
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.
Read the 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
- Being tested
- Laparoscopy
- Keywords
- intra-abdominal pressure, intra-cerebral pressure, laparoscopy, brain perfusion, brain oxygenation, time-resolved near infrared spectroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaparoscopyProcedure or surgery
The studies are carried out on patients who undergoes gynecological procedure that involves laparoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopy | The group consists of patients who undergoes laparoscopy procedure during which changes in cerebral oxygenation are estimated. Receives: Procedure: Laparoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 minutes (typically)
Secondary outcomes (2)
Cerebral oxygenation
Changes oxygenated (HbO2) and deoxygenated (Hb) hemoglobin concentrations expressed in micro Molars
Measured: 90 minutes (typically)
Fluctuations of changes in Hb and HbO2 concentrations
Fourier transform of changes in concentrations of Hb and HbO2
Measured: 90 minutes (typically)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start11 Jul 2016
- Primary completion25 Jul 2016
- Study completion18 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Increase in Intra-abdominal PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Lublin
- Responsible party
- Sponsor
- Investigators
- Adam Liebert, Prof, Study chair, Nalecz Institute of Biocybernetics and Biomedical Engineering
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03640741
- Sponsor's protocol ID
- IAP_UMLub_GBox
- Status last verified
- Aug 2018
- First submitted
- 17 Jul 2018
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 8656480Deeren 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.
PubMed 16193329Kacprzak 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.
PubMed 22352652
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03640741
- Acronym / sponsor ID
- IAP_UMLub_GBox
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of SciencesUniversity, hospital or other
- Collaborators
- Medical University of Lublin
- Study start
- 11 Jul 2016 (actual)
- Primary completion
- 25 Jul 2016 (actual)
- Study completion
- 18 Dec 2017 (actual)
- First posted
- 21 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laparoscopy | – | Procedure: LaparoscopyThe group consists of patients who undergoes laparoscopy procedure during which changes in cerebral oxygenation are estimated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of Gynecological Surgery Clinic
Key inclusion criteria (1 listed)
- laparoscopic procedure
Key exclusion criteria (1 listed)
- no consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LaparoscopyThe studies are carried out on patients who undergoes gynecological procedure that involves laparoscopy. | Procedure or surgery | Laparoscopy |
Primary outcome
Distribution of time of flight of photons
Time frame: 90 minutes (typically)
Distribution of time of flight of photons measured at 2 wavelengths, 690 nm and 830 nm and at 2 spots on a forehead
2 secondary outcomes
Cerebral oxygenation
Time frame: 90 minutes (typically)
Fluctuations of changes in Hb and HbO2 concentrations
Time frame: 90 minutes (typically)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
- Background: PubMed 8656480Bloomfield 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.
- Background: PubMed 16193329Deeren 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.
- Background: PubMed 22352652Kacprzak 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Liebert, Prof study chair
Nalecz Institute of Biocybernetics and Biomedical Engineering
Questions about this trial
What is this clinical trial studying?
An observational study of Increase in Intra-abdominal Pressure and Increase in Intracranial Pressure (ICP), run by Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of time of flight of photons (time frame: 90 minutes (typically)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03640741, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2018.