Abdominal Compartment SyndromeNCT02319213
This Study Performed to Develop a New Technique for Measuring the Intra Abdominal Pressure
A study testing Intraocular pressure measurement with 9 mmHg insufflation, Intraocular pressure measurement with 12 mmHg insufflation and Intraocular pressure measurement with 15 mmHg insufflation in people with Abdominal Compartment Syndrome, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to evaluate the changes of intraocular pressure due to the increase of intra abdominal pressure. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Abdominal Compartment Syndrome
- What is being tested?
- Intraocular pressure measurement with 9 mmHg insufflation, Intraocular pressure measurement with 12 mmHg insufflation and Intraocular pressure measurement with 15 mmHg insufflation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2008to Nov 2009
- Phase
- Interventional
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) of 30 kg/m2 or less
- American Society of Anesthesiologists (ASA) status I-II
Who cannot join
- Pre-existing eye disease,
- Cardiovascular or neuromuscular disease,
- Difficult intubation,
- The use of any antihypertensive agents.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Increase of Intra-abdominal Pressure Can Affect Intra-ocular Pressure.
The purpose of this study is to evaluate the changes of intraocular pressure due to the increase of intra abdominal pressure.
Read the detailed description
In this prospective study, 40 patients undergoing elective surgery were included. Patients were divided into four groups of 10 patients. The control group (Group C) was not subjected to laparoscopic intervention. Laparoscopic surgery was respectively performed with an intra-abdominal pressure of 9, 12 and 15 mmHg in Groups L (low), M (medium), and H (high pressure). Intraocular pressure was measured binocularly in each patient at three different time (before, during and end of surgery) using a contact tonometer.
- Conditions
- Abdominal Compartment Syndrome
- Being tested
- Intraocular pressure measurement with 9 mmHg insufflation, Intraocular pressure measurement with 12 mmHg insufflation, Intraocular pressure measurement with 15 mmHg insufflation
- Keywords
- Intra-abdominal pressure,, intraocular pressure,, abdominal hypertension,, laparoscopy,, critical care
- Medical subject headings
- Intra-Abdominal Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraocular pressure measurement with 9 mmHg insufflationOther
Comparison of intraocular pressure levels at different abdominal pressure
Intraocular pressure measurement with 12 mmHg insufflationOther
Comparison of intraocular pressure levels at different abdominal pressure
Intraocular pressure measurement with 15 mmHg insufflationOther
Comparison of intraocular pressure levels at different abdominal pressure
| Study group | Role | What they receive |
|---|---|---|
| Group C | No intervention | The control group (Group C) was not subjected to laparoscopic intervention |
| Group L | Experimental | Intraocular pressure measurement with 9 mmHg insufflation Receives: Other: Intraocular pressure measurement with 9 mmHg insufflation |
| Group M | Experimental | Intraocular pressure measurement with 12 mmHg insufflation Receives: Other: Intraocular pressure measurement with 12 mmHg insufflation |
| Group H | Experimental | Intraocular pressure measurement with 15 mmHg insufflation Receives: Other: Intraocular pressure measurement with 15 mmHg insufflation |
What is being measured
The primary outcome is the main question the study is designed to answer.
intra-abdominal pressure
Changes in intraabdominal pressure
Measured: 1 day after the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2014 (estimated)
- Study startMar 2008
- Primary completionJan 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal Compartment SyndromeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlhan Ece, Selcuk University
- Investigators
- İlhan Ece, Study director, Selcuk Universitesi Tip Fakultesi Genel Cerrahi poliklinigi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02319213
- Sponsor's protocol ID
- SU 08-38
- Status last verified
- Dec 2014
- First submitted
- 7 Dec 2014
- Last updated
- 18 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Ece I, Vatansev C, Kucukkartallar T, Tekin A, Kartal A, Okka M. The increase of intra-abdominal pressure can affect intraocular pressure. Biomed Res Int. 2015;2015:986895. doi: 10.1155/2015/986895. Epub 2015 Jan 14.
PubMed 25648230
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Increase of Intra-abdominal Pressure Can Affect Intra-ocular Pressure.
- ClinicalTrials.gov ID
- NCT02319213
- Acronym / sponsor ID
- SU 08-38
- Conditions
- Abdominal Compartment Syndrome
- Keywords
- Intra-abdominal pressure,, intraocular pressure,, abdominal hypertension,, laparoscopy,, critical care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 18 Dec 2014 (estimated)
- 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 purpose of this study is to evaluate the changes of intraocular pressure due to the increase of intra abdominal pressure.
Detailed description
In this prospective study, 40 patients undergoing elective surgery were included. Patients were divided into four groups of 10 patients. The control group (Group C) was not subjected to laparoscopic intervention. Laparoscopic surgery was respectively performed with an intra-abdominal pressure of 9, 12 and 15 mmHg in Groups L (low), M (medium), and H (high pressure). Intraocular pressure was measured binocularly in each patient at three different time (before, during and end of surgery) using a contact tonometer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group C | No intervention | –The control group (Group C) was not subjected to laparoscopic intervention |
| Group L | Experimental | Other: Intraocular pressure measurement with 9 mmHg insufflationIntraocular pressure measurement with 9 mmHg insufflation |
| Group M | Experimental | Other: Intraocular pressure measurement with 12 mmHg insufflationIntraocular pressure measurement with 12 mmHg insufflation |
| Group H | Experimental | Other: Intraocular pressure measurement with 15 mmHg insufflationIntraocular pressure measurement with 15 mmHg insufflation |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body mass index (BMI) of 30 kg/m2 or less
- American Society of Anesthesiologists (ASA) status I-II
Key exclusion criteria (4 listed)
- Pre-existing eye disease,
- Cardiovascular or neuromuscular disease,
- Difficult intubation,
- The use of any antihypertensive agents.
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 |
|---|---|---|
| Intraocular pressure measurement with 9 mmHg insufflationComparison of intraocular pressure levels at different abdominal pressure | Other | Group L |
| Intraocular pressure measurement with 12 mmHg insufflationComparison of intraocular pressure levels at different abdominal pressure | Other | Group M |
| Intraocular pressure measurement with 15 mmHg insufflationComparison of intraocular pressure levels at different abdominal pressure | Other | Group H |
Primary outcome
intra-abdominal pressure
Time frame: 1 day after the surgery.
Changes in intraabdominal pressure
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 18 Dec 2014.
- Derived from this study: PubMed 25648230Ece I, Vatansev C, Kucukkartallar T, Tekin A, Kartal A, Okka M. The increase of intra-abdominal pressure can affect intraocular pressure. Biomed Res Int. 2015;2015:986895. doi: 10.1155/2015/986895. Epub 2015 Jan 14.
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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.
İlhan Ece study director
Selcuk Universitesi Tip Fakultesi Genel Cerrahi poliklinigi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraocular pressure measurement with 9 mmHg insufflation, Intraocular pressure measurement with 12 mmHg insufflation and Intraocular pressure measurement with 15 mmHg insufflation in people with Abdominal Compartment Syndrome, run by Selcuk University at 1 site in Turkey (Türkiye).
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 2 inclusion and 4 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 18 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
intra-abdominal pressure (time frame: 1 day after the surgery.). 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 NCT02319213, which also lists 1 linked publication.
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 18 Dec 2014.