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

NCT07188922 | Completed

• 1 other identifier: EFSH-ANES-2025-09-VENT
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Mechanical Ventilation

Keywords

Intraocular Pressure (IOP); Mechanical Ventilation; Spontaneous Breathing; Ventilator Weaning; Intensive Care Unit; Prospective Observational Study

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Within 2 hours before and 2 hours after ventilator weaning

• Change in Heart Rate Before and After Transition to Spontaneous Breathing

  Within 2 hours before and 2 hours after ventilator weaning

Study Arms (1)

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.

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

Interventions

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.

Also known as: Intraocular Pressure Measurement

ICU Weaning Cohort

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sevim Şenol Karataş: lead

Study Sites (1)

Elazığ Fethi Sekin City Hospital

Elâzığ, Merkez, 23200, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 18452762 BACKGROUND

• 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.

  PMID: 11790214 BACKGROUND

• 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.

  PMID: 17470624 BACKGROUND

Related Links

• Elazığ Fethi Sekin City Hospital, Department of Anesthesiology and Reanimation

MeSH Terms

Interventions

Intraocular Pressure

Intervention Hierarchy (Ancestors)

Ocular Physiological Phenomena

Study Officials

• Sevim Şenol Karataş

  Elazığ Fethi Sekin City Hospital, Department of Anesthesiology and Reanimation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Specialist in Anesthesiology

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 23, 2025
• Study Start: September 16, 2025
• Primary Completion: October 16, 2025
• Study Completion: October 16, 2025
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)