Intraocular PressureNCT03938402
Intraocular Pressure and Optic Nerve Sheath Diameter Changes at Different PEEP Levels
A study testing Positive end-expiratory pressure in people with Intraocular Pressure and Intracranial Pressure, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Positive end-expiratory pressure (PEEP) is sometimes used during perioperative period, as it has favourable effects on lung mechanics. Unfortunately, it has some negative effects on the patients, like increased intraabdominal, intrathoracic, intracranial and intraocular pressures. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intraocular Pressure, Intracranial Pressure, Positive End-expiratory Pressure
- What is being tested?
- Positive end-expiratory pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2019to 31 Dec 2020
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing laparotomy for gastrointestinal surgery
- American Society of Anesthesiologists (ASA) 1 or 2 physical status
- Elective surgery
Who cannot join
- Patients with glaucoma
- ASA 3 or over physical status
- Emergency surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University School of Medicine
Istanbul, Pendik, 34899
About this study
Official title: Intraocular Pressure and Optic Nerve Sheath Diameter Changes at Different Positive End-expiratory Pressure Applications in Laparotomic Surgery
Positive end-expiratory pressure (PEEP) is sometimes used during perioperative period, as it has favourable effects on lung mechanics. Unfortunately, it has some negative effects on the patients, like increased intraabdominal, intrathoracic, intracranial and intraocular pressures. In this study the investigators aimed to investigate the effects of different PEEP levels on the patients' intraocular and intracranial pressures. Intraocular pressure will be measured by ocular tonometry, and intracranial pressure will be estimated by optic nerve sheath diameter measurement. The measurements will be performed in the operating room in the patients undergoing laparotomic surgery.
- Being tested
- Positive end-expiratory pressure
- Keywords
- Intraocular pressure, Optic nerve sheath diameter, Positive end-expiratory pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive end-expiratory pressureOther
Different levels of positive end-expiratory pressure (i.e., 5, 10 and 15 cm H2O) will be applied to the groups.
| Study group | Role | What they receive |
|---|---|---|
| PEEP 5 | Experimental | Not described Receives: Other: Positive end-expiratory pressure |
| PEEP 10 | Experimental | Not described Receives: Other: Positive end-expiratory pressure |
| PEEP 15 | Experimental | Not described Receives: Other: Positive end-expiratory pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in intraocular pressure
The physiological value for intraocular pressure is 10-20 mm Hg. Changes in intraocular pressure will be observed throughout the surgery, as will its relationship with the positive end-expiratory pressure application.
Measured: Throughout the operation (usually about 1.5 hours).
Changes in optic nerve sheath diameter
Changes in optic nerve sheath diameter will be observed throughout the surgery, as will its relationship with the positive end-expiratory pressure application.
Measured: Throughout the operation (usually about 1.5 hours).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start1 Jul 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Why it stopped: As a result of COVID-19 pandemics
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruslan Abdullayev, Marmara University
- Investigators
- Ruslan Abdullayev, Principal investigator, Marmara University School of Medicine, Dep of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03938402
- Sponsor's protocol ID
- 09.2019.378
- Status last verified
- Nov 2021
- First submitted
- 27 Apr 2019
- Last updated
- 3 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraocular Pressure and Optic Nerve Sheath Diameter Changes at Different Positive End-expiratory Pressure Applications in Laparotomic Surgery
- ClinicalTrials.gov ID
- NCT03938402
- Acronym / sponsor ID
- 09.2019.378
- Keywords
- Intraocular pressure, Optic nerve sheath diameter, Positive end-expiratory pressure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: As a result of COVID-19 pandemics
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 6 May 2019 (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.
Positive end-expiratory pressure (PEEP) is sometimes used during perioperative period, as it has favourable effects on lung mechanics. Unfortunately, it has some negative effects on the patients, like increased intraabdominal, intrathoracic, intracranial and intraocular pressures. In this study the investigators aimed to investigate the effects of different PEEP levels on the patients' intraocular and intracranial pressures. Intraocular pressure will be measured by ocular tonometry, and intracranial pressure will be estimated by optic nerve sheath diameter measurement. The measurements will be performed in the operating room in the patients undergoing laparotomic surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PEEP 5 | Experimental | Other: Positive end-expiratory pressure |
| PEEP 10 | Experimental | Other: Positive end-expiratory pressure |
| PEEP 15 | Experimental | Other: Positive end-expiratory pressure |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing laparotomy for gastrointestinal surgery
- American Society of Anesthesiologists (ASA) 1 or 2 physical status
- Elective surgery
Key exclusion criteria (3 listed)
- Patients with glaucoma
- ASA 3 or over physical status
- Emergency surgery
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 |
|---|---|---|
| Positive end-expiratory pressureDifferent levels of positive end-expiratory pressure (i.e., 5, 10 and 15 cm H2O) will be applied to the groups. | Other | PEEP 10, PEEP 15, PEEP 5 |
Primary outcome
Changes in intraocular pressure
Time frame: Throughout the operation (usually about 1.5 hours).
The physiological value for intraocular pressure is 10-20 mm Hg. Changes in intraocular pressure will be observed throughout the surgery, as will its relationship with the positive end-expiratory pressure application.
Changes in optic nerve sheath diameter
Time frame: Throughout the operation (usually about 1.5 hours).
Changes in optic nerve sheath diameter will be observed throughout the surgery, as will its relationship with the positive end-expiratory pressure application.
Results and safety
The study was stopped early (reason given: As a result of COVID-19 pandemics). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2021.
- Individual participant dataSharing planned: No
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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.
Ruslan Abdullayev principal investigator
Marmara University School of Medicine, Dep of Anesthesiology and Reanimation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive end-expiratory pressure in people with Intraocular Pressure and Intracranial Pressure, run by Marmara 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 3 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: stopped early, as of the sponsor's last update on 3 Dec 2021. 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 was stopped early (reason given: As a result of COVID-19 pandemics). Results are not available in the source record.
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?
Changes in intraocular pressure (time frame: Throughout the operation (usually about 1.5 hours).). The study lists 2 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 3 Dec 2021.