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NCT Number: NCT07188922

Effect of Transition From Mechanical Ventilation to Spontaneous Breathing on Intraocular Pressure in ICU (VENT-IOP)

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Elazığ Fethi Sekin City Hospital

Elâzığ, Merkez, 23200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

Other

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 names: Intraocular Pressure Measurement

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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.

  2. Change in Heart Rate Before and After Transition to Spontaneous Breathing

    Time frame: Within 2 hours before and 2 hours after ventilator weaning

    Heart rate will be monitored continuously. Measurements will be documented within 2 hours before and 2 hours after the transition to spontaneous breathing.

Sponsors and collaborators

Lead sponsor

Sevim Şenol Karataş

Other

Registry information

Official study title

Effect of Transition From Mechanical Ventilation to Spontaneous Breathing on Intraocular Pressure: A Prospective Observational Study in ICU Patients

Acronym: VENT-IOP

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 23, 2025
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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