Mechanical VentilationVENT-IOPNCT07188922
Effect of Transition From Mechanical Ventilation to Spontaneous Breathing on Intraocular Pressure in ICU (VENT-IOP)
An observational study of Mechanical Ventilation, run by Sevim Şenol Karataş at 1 site in Turkey (Türkiye).
Trial summary
This prospective, single-center observational study aims to evaluate the acute effects of transitioning from mechanical ventilation to spontaneous breathing on intraocular pressure (IOP) in intensive care unit patients. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Mechanical Ventilation
- What is being tested?
- Non-invasive intraocular pressure measurement during ventilator weaning Description: Intraocular pressure will be measured using a portable non-invasive tonometer before and after the transition from
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Sep 2025to 16 Oct 2025
- 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: Adult patients admitted to the intensive care unit of Elazığ Fethi Sekin City Hospital, Department of Anesthesiology and Reanimation, who are receiving invasive mechanical ventilation and undergoing clinically indicated weaning.
Who may be able to join
- Age between 18 and 85 years
- Admitted to intensive care unit (ICU) and receiving invasive mechanical ventilation
- Clinically scheduled for weaning and transition to spontaneous breathing
- Able to undergo intraocular pressure (IOP) measurement before and after transition
- Written informed consent obtained from the patient or legal representative
Who cannot join
- History of glaucoma, ocular hypertension, or previous eye surgery
- Active ocular infection or trauma
- Hemodynamic instability that prevents safe measurement
- Inability to obtain reliable IOP measurements
- Refusal of consent by patient or legal representative
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Elazığ Fethi Sekin City Hospital
Elâzığ, Merkez, 23200
About this study
Official title: Effect of Transition From Mechanical Ventilation to Spontaneous Breathing on Intraocular Pressure: A Prospective Observational Study in ICU Patients
This prospective, single-center observational study aims to evaluate the acute effects of transitioning from mechanical ventilation to spontaneous breathing on intraocular pressure (IOP) in intensive care unit patients. Forty adult patients receiving invasive mechanical ventilation and undergoing weaning will be enrolled. IOP will be measured non-invasively before and after the transition, without any intervention beyond routine clinical care. The primary objective is to determine whether spontaneous breathing after mechanical ventilation causes significant changes in IOP. Findings may provide insights into ocular physiology during weaning and contribute to the safe management of critically ill patients, particularly those with ocular risk factors.
Read the detailed description
Mechanical ventilation is an essential life-supporting therapy for critically ill patients with respiratory failure. However, prolonged mechanical ventilation is associated with increased risks of complications, making the weaning process a critical step in intensive care management. During weaning, patients are transitioned from supported modes (such as SIMV or PSV) to spontaneous breathing modes (such as CPAP or T-tube). This transition leads to changes in thoracic pressure and venous return, which may in turn affect intracranial and intraocular pressures.
Intraocular pressure (IOP) is a key parameter for maintaining ocular perfusion and is influenced by systemic hemodynamics, respiratory patterns, and intrathoracic pressure changes. Previous studies have shown that posture, Valsalva maneuvers, and mechanical ventilation can alter IOP. However, evidence on the acute effects of transitioning from invasive mechanical ventilation to spontaneous breathing on IOP remains limited.
This prospective, observational, single-center study will be conducted in the intensive care unit of Elazığ Fethi Sekin City Hospital, Department of Anesthesiology and Reanimation. Forty adult patients receiving invasive mechanical ventilation and undergoing clinically indicated weaning will be enrolled. IOP will be measured non-invasively before and after the transition to spontaneous breathing, using portable tonometry, without the use of topical anesthesia. Measurements will be taken in both eyes, and average values will be recorded.
Demographic and clinical data, including age, sex, diagnosis, duration of ventilation, sedation status (RASS), and timing of mode transition, will also be collected. The primary endpoint is the difference in IOP before and after the transition. Statistical analysis will include paired t-test or Wilcoxon signed-rank test, depending on data distribution. Repeated measures ANOVA or Friedman test will be used when applicable, with significance set at p < 0.05.
This study does not involve any intervention or deviation from standard clinical care. All weaning procedures will be conducted according to routine ICU protocols. The findings of this study are expected to contribute to the understanding of ocular physiology during critical illness and may be particularly relevant for the safe management of patients with ocular comorbidities such as glaucoma.
- Conditions
- Mechanical Ventilation
- Being tested
- Non-invasive intraocular pressure measurement during ventilator weaning Description: Intraocular pressure will be measured using a portable non-invasive tonometer before and after the transition from
- Keywords
- Intraocular Pressure (IOP), Mechanical Ventilation, Spontaneous Breathing, Ventilator Weaning, Intensive Care Unit, Prospective Observational Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive intraocular pressure measurement during ventilator weaning Description: Intraocular pressure will be measured using a portable non-invasive tonometer before and after the transition fromOther
Also called Intraocular Pressure Measurement
Intraocular pressure will be measured using a portable non-invasive tonometer before and after the transition from mechanical ventilation to spontaneous breathing. Measurements will be performed as part of routine clinical care and will not involve any experimental intervention.
| Study group | Role | What they receive |
|---|---|---|
| ICU Weaning Cohort | Adult patients in the intensive care unit undergoing transition from mechanical ventilation to spontaneous breathing. Intraocular pressure will be measured before and after the transition without any additional intervention beyond routine care. Receives: Other: Non-invasive intraocular pressure measurement during ventilator weaning Description: Intraocular pressure will be measured using a portable non-invasive tonometer before and after the transition from |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Intraocular Pressure (IOP) Before and After Transition to Spontaneous Breathing
Intraocular pressure will be measured in both eyes using a portable non-invasive tonometer within 2 hours before and within 2 hours after the transition from mechanical ventilation to spontaneous breathing. The average value will be used for analysis. The primary endpoint is the difference in IOP values before and after the transition.
Measured: Within 2 hours before and within 2 hours after ventilator weaning (transition to spontaneous breathing)
Secondary outcomes (2)
Change in Mean Arterial Pressure (MAP) Before and After Transition to Spontaneous Breathing
Mean arterial pressure will be recorded within 2 hours before and within 2 hours after transition from mechanical ventilation to spontaneous breathing. Values will be compared to assess hemodynamic changes during weaning.
Measured: Within 2 hours before and 2 hours after ventilator weaning
Change in Heart Rate Before and After Transition to Spontaneous Breathing
Heart rate will be monitored continuously. Measurements will be documented within 2 hours before and 2 hours after the transition to spontaneous breathing.
Measured: Within 2 hours before and 2 hours after ventilator weaning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start16 Sep 2025
- Primary completion16 Oct 2025
- Study completion16 Oct 2025
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 Mechanical VentilationStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sevim Şenol Karataş
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sevim Şenol Karataş, Elazıg Fethi Sekin Sehir Hastanesi
- Investigators
- Sevim Şenol Karataş, Principal investigator, Elazığ Fethi Sekin City Hospital, Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07188922
- Sponsor's protocol ID
- EFSH-ANES-2025-09-VENT
- Acronym
- VENT-IOP
- Status last verified
- Nov 2025
- First submitted
- 16 Sep 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because this is a single-center observational study with a limited sample size. Only aggregate data will be analyzed and reported in publications. Sharing IPD is not planned in order to protect patient confidentiality and comply with local ethical regulations.
Publications
Berdahl JP, Allingham RR, Johnson DH. Cerebrospinal fluid pressure is decreased in primary open-angle glaucoma. Ophthalmology. 2008 May;115(5):763-8. doi: 10.1016/j.ophtha.2008.01.013.
PubMed 18452762Esteban A, Anzueto A, Frutos F, Alia I, Brochard L, Stewart TE, Benito S, Epstein SK, Apezteguia C, Nightingale P, Arroliga AC, Tobin MJ; Mechanical Ventilation International Study Group. Characteristics and outcomes in adult patients receiving mechanical ventilation: a 28-day international study. JAMA. 2002 Jan 16;287(3):345-55. doi: 10.1001/jama.287.3.345.
PubMed 11790214Boles JM, Bion J, Connors A, Herridge M, Marsh B, Melot C, Pearl R, Silverman H, Stanchina M, Vieillard-Baron A, Welte T. Weaning from mechanical ventilation. Eur Respir J. 2007 May;29(5):1033-56. doi: 10.1183/09031936.00010206.
PubMed 17470624
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transition From Mechanical Ventilation to Spontaneous Breathing on Intraocular Pressure: A Prospective Observational Study in ICU Patients
- ClinicalTrials.gov ID
- NCT07188922
- Acronym / sponsor ID
- VENT-IOP / EFSH-ANES-2025-09-VENT
- Conditions
- Mechanical Ventilation
- Keywords
- Intraocular Pressure (IOP), Mechanical Ventilation, Spontaneous Breathing, Ventilator Weaning, Intensive Care Unit, Prospective Observational Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sevim Şenol KarataşUniversity, hospital or other
- Study start
- 16 Sep 2025 (actual)
- Primary completion
- 16 Oct 2025 (actual)
- Study completion
- 16 Oct 2025 (actual)
- First posted
- 23 Sep 2025 (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.
This prospective, single-center observational study aims to evaluate the acute effects of transitioning from mechanical ventilation to spontaneous breathing on intraocular pressure (IOP) in intensive care unit patients. Forty adult patients receiving invasive mechanical ventilation and undergoing weaning will be enrolled. IOP will be measured non-invasively before and after the transition, without any intervention beyond routine clinical care. The primary objective is to determine whether spontaneous breathing after mechanical ventilation causes significant changes in IOP. Findings may provide insights into ocular physiology during weaning and contribute to the safe management of critically ill patients, particularly those with ocular risk factors.
Detailed description
Mechanical ventilation is an essential life-supporting therapy for critically ill patients with respiratory failure. However, prolonged mechanical ventilation is associated with increased risks of complications, making the weaning process a critical step in intensive care management. During weaning, patients are transitioned from supported modes (such as SIMV or PSV) to spontaneous breathing modes (such as CPAP or T-tube). This transition leads to changes in thoracic pressure and venous return, which may in turn affect intracranial and intraocular pressures.
Intraocular pressure (IOP) is a key parameter for maintaining ocular perfusion and is influenced by systemic hemodynamics, respiratory patterns, and intrathoracic pressure changes. Previous studies have shown that posture, Valsalva maneuvers, and mechanical ventilation can alter IOP. However, evidence on the acute effects of transitioning from invasive mechanical ventilation to spontaneous breathing on IOP remains limited.
This prospective, observational, single-center study will be conducted in the intensive care unit of Elazığ Fethi Sekin City Hospital, Department of Anesthesiology and Reanimation. Forty adult patients receiving invasive mechanical ventilation and undergoing clinically indicated weaning will be enrolled. IOP will be measured non-invasively before and after the transition to spontaneous breathing, using portable tonometry, without the use of topical anesthesia. Measurements will be taken in both eyes, and average values will be recorded.
Demographic and clinical data, including age, sex, diagnosis, duration of ventilation, sedation status (RASS), and timing of mode transition, will also be collected. The primary endpoint is the difference in IOP before and after the transition. Statistical analysis will include paired t-test or Wilcoxon signed-rank test, depending on data distribution. Repeated measures ANOVA or Friedman test will be used when applicable, with significance set at p < 0.05.
This study does not involve any intervention or deviation from standard clinical care. All weaning procedures will be conducted according to routine ICU protocols. The findings of this study are expected to contribute to the understanding of ocular physiology during critical illness and may be particularly relevant for the safe management of patients with ocular comorbidities such as glaucoma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU Weaning Cohort | – | Other: Non-invasive intraocular pressure measurement during ventilator weaning Description: Intraocular pressure will be measured using a portable non-invasive tonometer before and after the transition fromAdult patients in the intensive care unit undergoing transition from mechanical ventilation to spontaneous breathing. Intraocular pressure will be measured before and after the transition without any additional intervention beyond routine care. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to the intensive care unit of Elazığ Fethi Sekin City Hospital, Department of Anesthesiology and Reanimation, who are receiving invasive mechanical ventilation and undergoing clinically indicated weaning.
Key inclusion criteria (5 listed)
- Age between 18 and 85 years
- Admitted to intensive care unit (ICU) and receiving invasive mechanical ventilation
- Clinically scheduled for weaning and transition to spontaneous breathing
- Able to undergo intraocular pressure (IOP) measurement before and after transition
- Written informed consent obtained from the patient or legal representative
Key exclusion criteria (5 listed)
- History of glaucoma, ocular hypertension, or previous eye surgery
- Active ocular infection or trauma
- Hemodynamic instability that prevents safe measurement
- Inability to obtain reliable IOP measurements
- Refusal of consent by patient or legal representative
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 |
|---|---|---|
| Non-invasive intraocular pressure measurement during ventilator weaning Description: Intraocular pressure will be measured using a portable non-invasive tonometer before and after the transition fromAlso: Intraocular Pressure MeasurementIntraocular pressure will be measured using a portable non-invasive tonometer before and after the transition from mechanical ventilation to spontaneous breathing. Measurements will be performed as part of routine clinical care and will not involve any experimental intervention. | Other | ICU Weaning Cohort |
Primary outcome
Change in Intraocular Pressure (IOP) Before and After Transition to Spontaneous Breathing
Time frame: Within 2 hours before and within 2 hours after ventilator weaning (transition to spontaneous breathing)
Intraocular pressure will be measured in both eyes using a portable non-invasive tonometer within 2 hours before and within 2 hours after the transition from mechanical ventilation to spontaneous breathing. The average value will be used for analysis. The primary endpoint is the difference in IOP values before and after the transition.
2 secondary outcomes
Change in Mean Arterial Pressure (MAP) Before and After Transition to Spontaneous Breathing
Time frame: Within 2 hours before and 2 hours after ventilator weaning
Change in Heart Rate Before and After Transition to Spontaneous Breathing
Time frame: Within 2 hours before and 2 hours after ventilator weaning
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 3 Dec 2025.
- Background: PubMed 18452762Berdahl JP, Allingham RR, Johnson DH. Cerebrospinal fluid pressure is decreased in primary open-angle glaucoma. Ophthalmology. 2008 May;115(5):763-8. doi: 10.1016/j.ophtha.2008.01.013.
- Background: PubMed 11790214Esteban A, Anzueto A, Frutos F, Alia I, Brochard L, Stewart TE, Benito S, Epstein SK, Apezteguia C, Nightingale P, Arroliga AC, Tobin MJ; Mechanical Ventilation International Study Group. Characteristics and outcomes in adult patients receiving mechanical ventilation: a 28-day international study. JAMA. 2002 Jan 16;287(3):345-55. doi: 10.1001/jama.287.3.345.
- Background: PubMed 17470624Boles JM, Bion J, Connors A, Herridge M, Marsh B, Melot C, Pearl R, Silverman H, Stanchina M, Vieillard-Baron A, Welte T. Weaning from mechanical ventilation. Eur Respir J. 2007 May;29(5):1033-56. doi: 10.1183/09031936.00010206.
- Elazığ Fethi Sekin City Hospital, Department of Anesthesiology and ReanimationLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because this is a single-center observational study with a limited sample size. Only aggregate data will be analyzed and reported in publications. Sharing IPD is not planned in order to protect patient confidentiality and comply with local ethical regulations.
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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.
Sevim Şenol Karataş principal investigator
Elazığ Fethi Sekin City Hospital, Department 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?
An observational study of Mechanical Ventilation, run by Sevim Şenol Karataş 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 5 inclusion and 5 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 3 Dec 2025. 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?
Change in Intraocular Pressure (IOP) Before and After Transition to Spontaneous Breathing (time frame: Within 2 hours before and within 2 hours after ventilator weaning (transition to spontaneous breathing)). 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 NCT07188922, 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 3 Dec 2025.