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Effect of Ventilation Mode in the Pupillary Light Reflex: A Crossover Study

NCT07082569 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-07-24

No results posted yet for this study

Summary

The goal of this clinical trial is to explore whether different modes of mechanical ventilation affect pupillary constriction velocities in critically ill patients without brain injury. The study aims to determine whether the type of mechanical ventilation (volume control, pressure control, or pressure-regulated volume control) influences the maximum and mean constriction velocity measured by automated pupillometry. The trial also investigates whether changes in pupil dynamics reflect subtle alterations in brainstem-autonomic interaction induced by ventilation mode.

The comparison involves volume control, pressure control, and pressure-regulated volume control in a randomized crossover design to assess whether ventilation mode has a measurable effect on pupil response.

Eligible participants will be intubated ICU patients receiving assist control ventilation who are not yet ready for spontaneous breathing trials. Serial pupillometry measurements will be conducted while participants are ventilated with each mode for at least 15 minutes. Sedation and lighting conditions will remain consistent throughout the protocol. Participants with acute or chronic neurologic conditions or ventilator dyssynchrony will be excluded.

Conditions

  • Mechanical Ventilation
  • Critical Illness

Interventions

OTHER

Volume Control Ventilation

Standard mode of mechanical ventilation delivering a preset tidal volume. Commonly used in ICU patients requiring controlled ventilation.

OTHER

Pressure Control Ventilation

Pressure-targeted ventilation mode that delivers breaths at a fixed pressure. Commonly used in critically ill patients.

OTHER

Pressure-Regulated Volume Control (PRVC)

Hybrid ventilation mode that automatically adjusts inspiratory pressure to achieve a preset tidal volume.

Sponsors & Collaborators

  • Evangelismos Hospital

    lead OTHER

Principal Investigators

  • Charikleia S Vrettou, MD, PhD · !st ICU dpt., Evangelismos General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-15
Primary Completion
2025-09-15
Completion
2026-09-30

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07082569 on ClinicalTrials.gov