Mechanical VentilationEYE-BREATHNCT07082569
Effect of Ventilation Mode in the Pupillary Light Reflex: A Crossover Study
A study of Mechanical Ventilation and Critical Illness, run by Evangelismos Hospital at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation, Critical Illness
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteGreece
- Study dates
- 15 Jul 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (≥18 years old)
- Receiving positive-pressure mechanical ventilation
- Under light or no sedation (e.g., RASS score between -2 and 0)
- Clinically assessed by the treating physician as not yet ready for weaning from mechanical ventilation
- Hemodynamically stable at the time of measurement
- Presence of an arterial catheter in place for blood gas analysis
Show all 13Show fewer
- Written informed consent obtained from the patient's legal representative Exclusion Criteria
- Acute or chronic neurological disease affecting brainstem function or pupillary responses
- Dyssynchrony with the ventilator or need for high ventilatory support adjustments
- Facial injuries, edema, or conditions precluding accurate pupillometry
- Use of neuromuscular blocking agents within the prior 6 hours
- Severe metabolic or acid-base imbalances that may influence autonomic regulation
- Concurrent participation in another interventional study that could affect neurological or autonomic outcomes
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
This is a prospective, randomized, crossover study designed to evaluate the effect of different modes of mechanical ventilation on pupillary constriction velocity in critically ill patients. Recent data suggest that even in the absence of direct pulmonary or neurologic injury, mechanical ventilation with positive pressure may impact brain function, possibly through vagal-brainstem-autonomic pathways. These effects may be subtle and difficult to detect with standard neurological examination but may be reflected in changes in the dynamic pupillary light reflex.
The pupillary light reflex (PLR), measured using automated infrared pupillometry, provides a quantitative, non-invasive assessment of brainstem and autonomic nervous system function. IThe investigators aim to determine whether the PLR, specifically, the mean and maximum constriction velocity, differs across three commonly used ventilation modes: Volume Control (VC), Pressure Control (PC), and Pressure-Regulated Volume Control (PRVC).
All included participants will be mechanically ventilated, sedated, and not yet candidates for spontaneous breathing trials. Exclusion criteria include any acute or chronic neurologic disorder or signs of ventilator dyssynchrony. Sedation regimens (e.g., propofol, remifentanil, dexmedetomidine) will be kept constant during the study, and ambient light will remain unchanged.
Each participant will undergo the three ventilation modes in a randomized order, with each mode applied for a minimum of 15 minutes to ensure washout before pupillometry measurements are performed. Physiological parameters such as respiratory rate, minute ventilation, FiO₂, heart rate, and mean arterial pressure will be recorded in parallel with pupil measurements. Blood gas analysis and full pupillometry data, including pupil size, constriction and dilation velocities, latency, and the Neurological Pupil Index (NPi), will also be collected.
The primary outcome is the difference in maximum pupillary constriction velocity between ventilation modes. Secondary outcomes include mean constriction velocity, NPi, and other pupillary metrics. Based on pilot data, a total of 36 participants are required to detect a significant difference in the primary outcome. Statistical analysis will include repeated measures ANOVA or the Friedman test, with post hoc Wilcoxon Signed-Rank testing as appropriate.
The findings of this study may provide support for the use of pupillometry as a tool to assess subtle CNS effects of mechanical ventilation and could support the theory of ventilation-brainstem interactions during mechanical ventilation.
- Conditions
- Mechanical Ventilation, Critical Illness
- Being tested
- Volume Control Ventilation, Pressure Control Ventilation, Pressure-Regulated Volume Control (PRVC)
- Keywords
- Critical illness, Mechanical ventilation, Pupillary light reflex, Automated pupillometry, Neurological Pupil Index
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volume Control VentilationOther
Standard mode of mechanical ventilation delivering a preset tidal volume. Commonly used in ICU patients requiring controlled ventilation.
Pressure Control VentilationOther
Pressure-targeted ventilation mode that delivers breaths at a fixed pressure. Commonly used in critically ill patients.
Pressure-Regulated Volume Control (PRVC)Other
Hybrid ventilation mode that automatically adjusts inspiratory pressure to achieve a preset tidal volume.
| Study group | Role | What they receive |
|---|---|---|
| Sequence A: VC → PC → PRVC | Experimental | Participants receive mechanical ventilation in the following sequence: Volume Control (VC), followed by Pressure Control (PC), then Pressure-Regulated Volume Control (PRVC). Pupillometry is performed after each mode following a 15-minute stabilization period. Receives: Other: Volume Control Ventilation; Other: Pressure Control Ventilation; Other: Pressure-Regulated Volume Control (PRVC) |
| Sequence B: VC → PRVC → PC | Other | Participants receive mechanical ventilation in the following sequence: Volume Control (VC), followed by Pressure-Regulated Volume Control (PRVC), then Pressure Control (PC). Pupillometry is performed after each mode following a 15-minute stabilization period. Receives: Other: Volume Control Ventilation; Other: Pressure Control Ventilation; Other: Pressure-Regulated Volume Control (PRVC) |
| Sequence C: PC → VC → PRVC | Other | Participants receive mechanical ventilation in the following sequence: Pressure Control (PC), followed by Volume Control (VC), then Pressure-Regulated Volume Control (PRVC). Pupillometry is performed after each mode following a 15-minute stabilization period. Receives: Other: Volume Control Ventilation; Other: Pressure Control Ventilation; Other: Pressure-Regulated Volume Control (PRVC) |
| Sequence D: PC → PRVC → VC | Other | Participants receive mechanical ventilation in the following sequence: Pressure Control (PC), followed by Pressure-Regulated Volume Control (PRVC), then Volume Control (VC). Pupillometry is performed after each mode following a 15-minute stabilization period. Receives: Other: Volume Control Ventilation; Other: Pressure Control Ventilation; Other: Pressure-Regulated Volume Control (PRVC) |
| Sequence E: PRVC → VC → PC | Other | Participants receive mechanical ventilation in the following sequence: Pressure-Regulated Volume Control (PRVC), followed by Volume Control (VC), then Pressure Control (PC). Pupillometry is performed after each mode following a 15-minute stabilization period. Receives: Other: Volume Control Ventilation; Other: Pressure Control Ventilation; Other: Pressure-Regulated Volume Control (PRVC) |
| Sequence F: PRVC → PC → VC | Other | Participants receive mechanical ventilation in the following sequence: Pressure-Regulated Volume Control (PRVC), followed by Pressure Control (PC), then Volume Control (VC). Pupillometry is performed after each mode following a 15-minute stabilization period. Receives: Other: Volume Control Ventilation; Other: Pressure Control Ventilation; Other: Pressure-Regulated Volume Control (PRVC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Pupillary Constriction Velocity
Change in maximum pupillary constriction velocity (mm/s) in response to standardized light stimulus, as measured by the NPi-200 pupillometer, under three modes of mechanical ventilation: Volume Control (VC), Pressure Control (PC), and Pressure-Regulated Volume Control (PRVC).
Measured: At 30 minutes after each ventilation mode initiation (VC, PC, PRVC).
Secondary outcomes (6)
Neurological Pupil Index (NPi)
Change in NPi value recorded under each ventilation mode, reflecting pupillary reactivity and brainstem function.
Measured: At 30 minutes after each ventilation mode initiation (VC, PC, PRVC).
Constriction Latency
Change in latency to onset of pupil constriction (seconds), measured using the NPi-200.
Measured: At 30 minutes after each ventilation mode initiation (VC, PC, PRVC).
Dilation Velocity
Change in maximum dilation velocity (mm/s) following light stimulus, measured with the NPi-200.
Measured: At 30 minutes after each ventilation mode initiation (VC, PC, PRVC).
Maximum Pupil Diameter
Change in maximum pupil diameter (mm) measured before light stimulation under each ventilation mode.
Measured: At 30 minutes after each ventilation mode initiation (VC, PC, PRVC).
Minimum Pupil Diameter
Change in minimum pupil diameter (mm) recorded after light stimulation.
Measured: At 30 minutes after each ventilation mode initiation (VC, PC, PRVC).
Percent Constriction
Percent change in pupil diameter from baseline in response to light stimulus.
Measured: At 30 minutes after each ventilation mode initiation (VC, PC, PRVC).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start15 Jul 2025 (estimated)
- Primary completion15 Sep 2025 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each participant will receive three different modes of mechanical ventilation (Volume Control, Pressure Control, Pressure-Regulated Volume Control) in a randomized order. Pupillometry measurements will be taken after each mode, with a 15-minute washout period between modes.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Evangelismos Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charikleia Vrettou, Evangelismos Hospital
- Investigators
- Charikleia S Vrettou, MD, PhD, Principal investigator, !st ICU dpt., Evangelismos General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07082569
- Sponsor's protocol ID
- PSVCPC
- Acronym
- EYE-BREATH
- Status last verified
- Jul 2025
- First submitted
- 5 Jul 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) related to primary and secondary outcome measures will be made available to other researchers upon reasonable request, after publication of the main study results.
Publications
Sibbald B, Roberts C. Understanding controlled trials. Crossover trials. BMJ. 1998 Jun 6;316(7146):1719. doi: 10.1136/bmj.316.7146.1719. No abstract available.
PubMed 9614025World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.
PubMed 24141714Muppidi S, Adams-Huet B, Tajzoy E, Scribner M, Blazek P, Spaeth EB, Frohman E, Davis S, Vernino S. Dynamic pupillometry as an autonomic testing tool. Clin Auton Res. 2013 Dec;23(6):297-303. doi: 10.1007/s10286-013-0209-7. Epub 2013 Jul 24.
PubMed 23880969Bassi TG, Rohrs EC, Fernandez KC, Ornowska M, Nicholas M, Gani M, Evans D, Reynolds SC. Transvenous Diaphragm Neurostimulation Mitigates Ventilation-associated Brain Injury. Am J Respir Crit Care Med. 2021 Dec 15;204(12):1391-1402. doi: 10.1164/rccm.202101-0076OC.
PubMed 34491883Cinnella G, Conti G, Lofaso F, Lorino H, Harf A, Lemaire F, Brochard L. Effects of assisted ventilation on the work of breathing: volume-controlled versus pressure-controlled ventilation. Am J Respir Crit Care Med. 1996 Mar;153(3):1025-33. doi: 10.1164/ajrccm.153.3.8630541.
PubMed 8630541Walter K. Mechanical Ventilation. JAMA. 2021 Oct 12;326(14):1452. doi: 10.1001/jama.2021.13084. No abstract available.
PubMed 34636861
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ventilation Mode in the Pupillary Light Reflex: A Crossover Study
- ClinicalTrials.gov ID
- NCT07082569
- Acronym / sponsor ID
- EYE-BREATH / PSVCPC
- Conditions
- Mechanical Ventilation, Critical Illness
- Keywords
- Critical illness, Mechanical ventilation, Pupillary light reflex, Automated pupillometry, Neurological Pupil Index
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Evangelismos HospitalUniversity, hospital or other
- Study start
- 15 Jul 2025 (estimated)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 24 Jul 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.
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.
Detailed description
This is a prospective, randomized, crossover study designed to evaluate the effect of different modes of mechanical ventilation on pupillary constriction velocity in critically ill patients. Recent data suggest that even in the absence of direct pulmonary or neurologic injury, mechanical ventilation with positive pressure may impact brain function, possibly through vagal-brainstem-autonomic pathways. These effects may be subtle and difficult to detect with standard neurological examination but may be reflected in changes in the dynamic pupillary light reflex.
The pupillary light reflex (PLR), measured using automated infrared pupillometry, provides a quantitative, non-invasive assessment of brainstem and autonomic nervous system function. IThe investigators aim to determine whether the PLR, specifically, the mean and maximum constriction velocity, differs across three commonly used ventilation modes: Volume Control (VC), Pressure Control (PC), and Pressure-Regulated Volume Control (PRVC).
All included participants will be mechanically ventilated, sedated, and not yet candidates for spontaneous breathing trials. Exclusion criteria include any acute or chronic neurologic disorder or signs of ventilator dyssynchrony. Sedation regimens (e.g., propofol, remifentanil, dexmedetomidine) will be kept constant during the study, and ambient light will remain unchanged.
Each participant will undergo the three ventilation modes in a randomized order, with each mode applied for a minimum of 15 minutes to ensure washout before pupillometry measurements are performed. Physiological parameters such as respiratory rate, minute ventilation, FiO₂, heart rate, and mean arterial pressure will be recorded in parallel with pupil measurements. Blood gas analysis and full pupillometry data, including pupil size, constriction and dilation velocities, latency, and the Neurological Pupil Index (NPi), will also be collected.
The primary outcome is the difference in maximum pupillary constriction velocity between ventilation modes. Secondary outcomes include mean constriction velocity, NPi, and other pupillary metrics. Based on pilot data, a total of 36 participants are required to detect a significant difference in the primary outcome. Statistical analysis will include repeated measures ANOVA or the Friedman test, with post hoc Wilcoxon Signed-Rank testing as appropriate.
The findings of this study may provide support for the use of pupillometry as a tool to assess subtle CNS effects of mechanical ventilation and could support the theory of ventilation-brainstem interactions during mechanical ventilation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
- Model description
- Each participant will receive three different modes of mechanical ventilation (Volume Control, Pressure Control, Pressure-Regulated Volume Control) in a randomized order. Pupillometry measurements will be taken after each mode, with a 15-minute washout period between modes.
| Arm | Type | Receives |
|---|---|---|
| Sequence A: VC → PC → PRVC | Experimental | Other: Volume Control Ventilation, Other: Pressure Control Ventilation, Other: Pressure-Regulated Volume Control (PRVC)Participants receive mechanical ventilation in the following sequence: Volume Control (VC), followed by Pressure Control (PC), then Pressure-Regulated Volume Control (PRVC). Pupillometry is performed after each mode following a 15-minute stabilization period. |
| Sequence B: VC → PRVC → PC | Other | Other: Volume Control Ventilation, Other: Pressure Control Ventilation, Other: Pressure-Regulated Volume Control (PRVC)Participants receive mechanical ventilation in the following sequence: Volume Control (VC), followed by Pressure-Regulated Volume Control (PRVC), then Pressure Control (PC). Pupillometry is performed after each mode following a 15-minute stabilization period. |
| Sequence C: PC → VC → PRVC | Other | Other: Volume Control Ventilation, Other: Pressure Control Ventilation, Other: Pressure-Regulated Volume Control (PRVC)Participants receive mechanical ventilation in the following sequence: Pressure Control (PC), followed by Volume Control (VC), then Pressure-Regulated Volume Control (PRVC). Pupillometry is performed after each mode following a 15-minute stabilization period. |
| Sequence D: PC → PRVC → VC | Other | Other: Volume Control Ventilation, Other: Pressure Control Ventilation, Other: Pressure-Regulated Volume Control (PRVC)Participants receive mechanical ventilation in the following sequence: Pressure Control (PC), followed by Pressure-Regulated Volume Control (PRVC), then Volume Control (VC). Pupillometry is performed after each mode following a 15-minute stabilization period. |
| Sequence E: PRVC → VC → PC | Other | Other: Volume Control Ventilation, Other: Pressure Control Ventilation, Other: Pressure-Regulated Volume Control (PRVC)Participants receive mechanical ventilation in the following sequence: Pressure-Regulated Volume Control (PRVC), followed by Volume Control (VC), then Pressure Control (PC). Pupillometry is performed after each mode following a 15-minute stabilization period. |
| Sequence F: PRVC → PC → VC | Other | Other: Volume Control Ventilation, Other: Pressure Control Ventilation, Other: Pressure-Regulated Volume Control (PRVC)Participants receive mechanical ventilation in the following sequence: Pressure-Regulated Volume Control (PRVC), followed by Pressure Control (PC), then Volume Control (VC). Pupillometry is performed after each mode following a 15-minute stabilization period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Adult patients (≥18 years old)
- Receiving positive-pressure mechanical ventilation
- Under light or no sedation (e.g., RASS score between -2 and 0)
- Clinically assessed by the treating physician as not yet ready for weaning from mechanical ventilation
- Hemodynamically stable at the time of measurement
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Volume Control VentilationStandard mode of mechanical ventilation delivering a preset tidal volume. Commonly used in ICU patients requiring controlled ventilation. | Other | Sequence A: VC → PC → PRVC, Sequence B: VC → PRVC → PC, Sequence C: PC → VC → PRVC, Sequence D: PC → PRVC → VC, Sequence E: PRVC → VC → PC, Sequence F: PRVC → PC → VC |
| Pressure Control VentilationPressure-targeted ventilation mode that delivers breaths at a fixed pressure. Commonly used in critically ill patients. | Other | Sequence A: VC → PC → PRVC, Sequence B: VC → PRVC → PC, Sequence C: PC → VC → PRVC, Sequence D: PC → PRVC → VC, Sequence E: PRVC → VC → PC, Sequence F: PRVC → PC → VC |
| Pressure-Regulated Volume Control (PRVC)Hybrid ventilation mode that automatically adjusts inspiratory pressure to achieve a preset tidal volume. | Other | Sequence A: VC → PC → PRVC, Sequence B: VC → PRVC → PC, Sequence C: PC → VC → PRVC, Sequence D: PC → PRVC → VC, Sequence E: PRVC → VC → PC, Sequence F: PRVC → PC → VC |
Primary outcome
Maximum Pupillary Constriction Velocity
Time frame: At 30 minutes after each ventilation mode initiation (VC, PC, PRVC).
Change in maximum pupillary constriction velocity (mm/s) in response to standardized light stimulus, as measured by the NPi-200 pupillometer, under three modes of mechanical ventilation: Volume Control (VC), Pressure Control (PC), and Pressure-Regulated Volume Control (PRVC).
6 secondary outcomes
Neurological Pupil Index (NPi)
Time frame: At 30 minutes after each ventilation mode initiation (VC, PC, PRVC).
Constriction Latency
Time frame: At 30 minutes after each ventilation mode initiation (VC, PC, PRVC).
Dilation Velocity
Time frame: At 30 minutes after each ventilation mode initiation (VC, PC, PRVC).
Maximum Pupil Diameter
Time frame: At 30 minutes after each ventilation mode initiation (VC, PC, PRVC).
Minimum Pupil Diameter
Time frame: At 30 minutes after each ventilation mode initiation (VC, PC, PRVC).
Percent Constriction
Time frame: At 30 minutes after each ventilation mode initiation (VC, PC, PRVC).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Background: PubMed 9614025Sibbald B, Roberts C. Understanding controlled trials. Crossover trials. BMJ. 1998 Jun 6;316(7146):1719. doi: 10.1136/bmj.316.7146.1719. No abstract available.
- Background: PubMed 24141714World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.
- Background: PubMed 23880969Muppidi S, Adams-Huet B, Tajzoy E, Scribner M, Blazek P, Spaeth EB, Frohman E, Davis S, Vernino S. Dynamic pupillometry as an autonomic testing tool. Clin Auton Res. 2013 Dec;23(6):297-303. doi: 10.1007/s10286-013-0209-7. Epub 2013 Jul 24.
- Background: PubMed 34491883Bassi TG, Rohrs EC, Fernandez KC, Ornowska M, Nicholas M, Gani M, Evans D, Reynolds SC. Transvenous Diaphragm Neurostimulation Mitigates Ventilation-associated Brain Injury. Am J Respir Crit Care Med. 2021 Dec 15;204(12):1391-1402. doi: 10.1164/rccm.202101-0076OC.
- Background: PubMed 8630541Cinnella G, Conti G, Lofaso F, Lorino H, Harf A, Lemaire F, Brochard L. Effects of assisted ventilation on the work of breathing: volume-controlled versus pressure-controlled ventilation. Am J Respir Crit Care Med. 1996 Mar;153(3):1025-33. doi: 10.1164/ajrccm.153.3.8630541.
- Background: PubMed 34636861Walter K. Mechanical Ventilation. JAMA. 2021 Oct 12;326(14):1452. doi: 10.1001/jama.2021.13084. No abstract available.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) related to primary and secondary outcome measures will be made available to other researchers upon reasonable request, after publication of the main study results.
Related trials for Mechanical Ventilation
Active, not recruitingObservational study
Potential Impact of the Use of the Application VentilO
Mechanical Ventilation Complication
Active, not recruiting
VentilO Prospective Study
Mechanical Ventilation Complication, Respiratory Acidosis
RecruitingObservational study
Frequency and Severity of Respiratory Acidosis During One-lung Ventilation, a Retrospective Pilot Study to Compare Clinician Settings and Those Proposed by the VentilO Application
Thoracic, Surgery
Active, not recruiting
Prevalence and Clinical Impact of Airway Opening Pressure in Post-Cardiac Surgery Patients
Cardiac Surgery, Mechanical Ventilation After Surgery
RecruitingObservational study
Evaluation of Acid-base Disorders and Ventilation Settings in Cardiogenic Shock and Post-cardiac Arrest Patients: Comparison With VentilO Algorithm
Cardiac Arrest (CA), Cardiogenic Shock
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.
Charikleia S Vrettou, MD, PhD principal investigator
!st ICU dpt., Evangelismos General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Mechanical Ventilation and Critical Illness, run by Evangelismos Hospital at 1 site in Greece.
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 13 inclusion and 0 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: opening soon, as of the sponsor's last update on 24 Jul 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 Greece. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charikleia S. Vrettou, MD, PhD (+302132105621 ext. 5621, vrettou@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Pupillary Constriction Velocity (time frame: At 30 minutes after each ventilation mode initiation (VC, PC, PRVC).). 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 NCT07082569, which also lists 6 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 24 Jul 2025; AzTrials last refreshed its copy on 6 Nov 2026.