Effect of Transition From Mechanical Ventilation to Spontaneous Breathing on Intraocular Pressure in ICU (VENT-IOP)
NCT ID: NCT07188922
Last Updated: 2025-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
40 participants
OBSERVATIONAL
2025-09-16
2025-10-16
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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
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.
Interventions
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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
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
85 Years
ALL
No
Sponsors
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Sevim Şenol Karataş
OTHER
Responsible Party
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Sevim Şenol Karataş
Specialist in Anesthesiology
Principal Investigators
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Sevim Şenol Karataş
Role: PRINCIPAL_INVESTIGATOR
Elazığ Fethi Sekin City Hospital, Department of Anesthesiology and Reanimation
Locations
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Elazığ Fethi Sekin City Hospital
Elâzığ, Merkez, Turkey (Türkiye)
Countries
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References
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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.
Esteban 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.
Boles 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.
Related Links
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Elazığ Fethi Sekin City Hospital, Department of Anesthesiology and Reanimation
Other Identifiers
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EFSH-ANES-2025-09-VENT
Identifier Type: -
Identifier Source: org_study_id
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