Major SurgeryNCT04556877
Different Intra-abdominal Pressures and Optic Nerve Size
An observational study of Major Surgery and Intraabdominal Hypertension, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
In intensive care patients, high intraabdominal pressure is frequently encountered. Intra-abdominal pressure is often measured as high, especially after major abdominal surgery procedures. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Major Surgery, Intraabdominal Hypertension, Optic Nerve Congestion
- What is being tested?
- Intraabdominal pressure and optic nerve diameters
- Type of treatment
- Surgery or procedure
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2018to 15 Jun 2020
- How long will I take part?
- 1 Day
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Postoperative patients followed in intensive care
Who may be able to join
- Having had major abdominal surgery
Who cannot join
- pregnant patients
- Patients whose bladder catheter cannot be inserted
- Patients with diagnosed or suspected brain death
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effects of Different Intra-abdominal Pressures on Optic Nerve Size Measured by Orbital USG in Patients Undergoing Major Abdominal Surgery
In intensive care patients, high intraabdominal pressure is frequently encountered. Intra-abdominal pressure is often measured as high, especially after major abdominal surgery procedures. In recent years, various studies have reported that the increase in optic nerve diameter measured by ultrasound correlates with the level of intracranial pressure. Optic nerve diameter measurement with ultrasound is a non-invasive procedure. Intra-abdominal pressure measurements are also routinely performed in intensive care patients. In the measurement of abdominal pressure, the bladder catheter, which is already available in every patient who comes to intensive care, is used. In this study, the intra-abdominal pressure values present in the file of each patient undergoing major abdominal surgery who were taken to intensive care unit will be taken. Orbital USG will be performed on the 6th, 12th and 24th hours on admission to the intensive care unit to measure the diameter of the optic nerve, and the relationship between the intra-abdominal pressure value and optic nerve diameters will be investigated.
Read the detailed description
In intensive care patients, high intraabdominal pressure is frequently encountered. Intra-abdominal pressure is often measured as high, especially after major abdominal surgery procedures. This situation creates ischemia in the abdominal organs in the patient, decreases venous return as a result of inferior vena cava compression and leads to a decrease in cardiac output. In addition, intracranial pressure frequently increases as a result of the venous circulation being affected. In recent years, various studies have reported that the increase in optic nerve diameter measured by ultrasound correlates with the level of intracranial pressure. Optic nerve diameter measurement with ultrasound is a non-invasive procedure. Intra-abdominal pressure measurements are also routinely performed in intensive care patients. In the measurement of abdominal pressure, the bladder catheter, which is already available in every patient who comes to intensive care, is used. In this study, the intra-abdominal pressure values present in the file of each patient undergoing major abdominal surgery who were taken to intensive care unit will be taken. Orbital USG will be performed on the 6th, 12th and 24th hours on admission to the intensive care unit to measure the diameter of the optic nerve, and the relationship between the intra-abdominal pressure value and optic nerve diameters will be investigated.
- Being tested
- Intraabdominal pressure and optic nerve diameters
- 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.
Intraabdominal pressure and optic nerve diametersProcedure or surgery
Measuring Intraabdominal pressure with a Foley cathater and measuring optic nerve diameters with a USG
| Study group | Role | What they receive |
|---|---|---|
| Intraabdominal pressure under 12 mmHg | Patients with intraabdominal pressure under 12 mmHg Receives: Procedure: Intraabdominal pressure and optic nerve diameters | |
| Intraabdominal pressure between 12-20 mmHg | Patients with intraabdominal pressure between 12-20 mmHg Receives: Procedure: Intraabdominal pressure and optic nerve diameters | |
| Intraabdominal pressure over 20 mmHg | Patients with intraabdominal pressure over 20 mmHg Receives: Procedure: Intraabdominal pressure and optic nerve diameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
optic nerve diameter
measuring optic nerve diameter
Measured: within 2 hours of admission
optic nerve diameter
measuring optic nerve diameter
Measured: at 6.hour
optic nerve diameter
measuring optic nerve diameter
Measured: at 12.hour
optic nerve diameter
measuring optic nerve diameter
Measured: at 24.hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start15 Jun 2018
- Primary completion15 Jun 2020
- Study completion15 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major SurgeryStudies 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 crossover
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Mehmet Turan Inal, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04556877
- Sponsor's protocol ID
- TUTF 2018/230
- Status last verified
- Sep 2020
- First submitted
- 7 Sep 2020
- Last updated
- 21 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Different Intra-abdominal Pressures on Optic Nerve Size Measured by Orbital USG in Patients Undergoing Major Abdominal Surgery
- ClinicalTrials.gov ID
- NCT04556877
- Acronym / sponsor ID
- TUTF 2018/230
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 21 Sep 2020 (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.
In intensive care patients, high intraabdominal pressure is frequently encountered. Intra-abdominal pressure is often measured as high, especially after major abdominal surgery procedures. In recent years, various studies have reported that the increase in optic nerve diameter measured by ultrasound correlates with the level of intracranial pressure. Optic nerve diameter measurement with ultrasound is a non-invasive procedure. Intra-abdominal pressure measurements are also routinely performed in intensive care patients. In the measurement of abdominal pressure, the bladder catheter, which is already available in every patient who comes to intensive care, is used. In this study, the intra-abdominal pressure values present in the file of each patient undergoing major abdominal surgery who were taken to intensive care unit will be taken. Orbital USG will be performed on the 6th, 12th and 24th hours on admission to the intensive care unit to measure the diameter of the optic nerve, and the relationship between the intra-abdominal pressure value and optic nerve diameters will be investigated.
Detailed description
In intensive care patients, high intraabdominal pressure is frequently encountered. Intra-abdominal pressure is often measured as high, especially after major abdominal surgery procedures. This situation creates ischemia in the abdominal organs in the patient, decreases venous return as a result of inferior vena cava compression and leads to a decrease in cardiac output. In addition, intracranial pressure frequently increases as a result of the venous circulation being affected. In recent years, various studies have reported that the increase in optic nerve diameter measured by ultrasound correlates with the level of intracranial pressure. Optic nerve diameter measurement with ultrasound is a non-invasive procedure. Intra-abdominal pressure measurements are also routinely performed in intensive care patients. In the measurement of abdominal pressure, the bladder catheter, which is already available in every patient who comes to intensive care, is used. In this study, the intra-abdominal pressure values present in the file of each patient undergoing major abdominal surgery who were taken to intensive care unit will be taken. Orbital USG will be performed on the 6th, 12th and 24th hours on admission to the intensive care unit to measure the diameter of the optic nerve, and the relationship between the intra-abdominal pressure value and optic nerve diameters will be investigated.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intraabdominal pressure under 12 mmHg | – | Procedure: Intraabdominal pressure and optic nerve diametersPatients with intraabdominal pressure under 12 mmHg |
| Intraabdominal pressure between 12-20 mmHg | – | Procedure: Intraabdominal pressure and optic nerve diametersPatients with intraabdominal pressure between 12-20 mmHg |
| Intraabdominal pressure over 20 mmHg | – | Procedure: Intraabdominal pressure and optic nerve diametersPatients with intraabdominal pressure over 20 mmHg |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Postoperative patients followed in intensive care
Key inclusion criteria (1 listed)
- Having had major abdominal surgery
Key exclusion criteria (3 listed)
- pregnant patients
- Patients whose bladder catheter cannot be inserted
- Patients with diagnosed or suspected brain death
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 |
|---|---|---|
| Intraabdominal pressure and optic nerve diametersMeasuring Intraabdominal pressure with a Foley cathater and measuring optic nerve diameters with a USG | Procedure or surgery | Intraabdominal pressure between 12-20 mmHg, Intraabdominal pressure over 20 mmHg, Intraabdominal pressure under 12 mmHg |
Primary outcome
optic nerve diameter
Time frame: within 2 hours of admission
measuring optic nerve diameter
optic nerve diameter
Time frame: at 6.hour
measuring optic nerve diameter
optic nerve diameter
Time frame: at 12.hour
measuring optic nerve diameter
optic nerve diameter
Time frame: at 24.hour
measuring optic nerve diameter
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 Sep 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Surgery and Intraabdominal Hypertension, run by Trakya 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 1 inclusion and 3 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 Sep 2020. 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?
optic nerve diameter (time frame: within 2 hours of admission). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2020.