Ventilation ModesNCT06961227
Effectiveness of Ventilation Modes in Intensive Care: A Comparison of Mandatory Minute Ventilation and Synchronized Intermittant Mandatory Ventilation Using Bioelectrical Impedance Tomography
An observational study of Ventilation Modes and Mechanical Ventilation, run by Harran University at 1 site in Turkey (Türkiye).
Trial summary
Synchronized Intermittent Mandatory Ventilation (SIMV) is a commonly used ventilatory mode available in many modern ventilators, frequently applied in intensive care units for patients requiring invasive mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ventilation Modes, Mechanical Ventilation, Critical Illness
- What is being tested?
- No investigational intervention
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2025to 31 Oct 2025
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients (≥18 years) admitted to the intensive care unit who are intubated and receiving invasive mechanical ventilation. All participants are hemodynamically stable and not receiving vasopressors, high levels of PEEP, or neuromuscular blockers at the time of enrollment.
Who may be able to join
- Age ≥ 18 years
- Intubated and receiving invasive mechanical ventilation
- Hemodynamically stable (no vasopressor support)
- FiO₂ ≤ 60%
- PEEP ≤ 8 cmH₂O
- Not receiving neuromuscular blocking agents
- Able to tolerate switching between SIMV and MMV modes
Who cannot join
- Pregnant or breastfeeding patients
- Patients with neuromuscular diseases affecting respiratory drive
- Unstable hemodynamics or ongoing need for vasopressors
- Patients requiring high PEEP (>8 cmH₂O)
- Patients with DNR (do not resuscitate) status
- Participation in another interventional study
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Harran University Faculty of Medicine, Department of Anesthesiology and Reanimation
Sanliurfa, 63000
Evren BÜYÜKFIRAT, Medical Doctor, +905065849686, evrenbf@gmail.com
About this study
Official title: Comparative Analysis of Ventilation Distribution in Intensive Care: Mandatory Minute Ventilation Versus Synchronized Intermittent Mandatory Ventilation Using Electrical Impedance Tomography"
Synchronized Intermittent Mandatory Ventilation (SIMV) is a commonly used ventilatory mode available in many modern ventilators, frequently applied in intensive care units for patients requiring invasive mechanical ventilation. SIMV delivers a preset tidal volume or pressure at a predetermined respiratory rate and synchronizes with the patient's spontaneous breathing efforts, thereby enhancing patient-ventilator interaction and contributing to rehabilitation.
Mandatory Minute Ventilation (MMV) is a hybrid mode combining features of SIMV and Pressure Support Ventilation (PSV), guaranteeing a preset minute ventilation (tidal volume × respiratory rate). It synchronizes support based on the patient's spontaneous efforts and compensates in cases of insufficient minute ventilation.
Read more
Electrical Impedance Tomography (EIT) is a non-invasive, radiation-free imaging technique that enables real-time monitoring of pulmonary ventilation and perfusion by applying alternating electrical currents through surface electrodes. EIT has demonstrated strong correlation with findings from computed tomography, nitrogen washout, PET, and SPECT imaging modalities.
This study aims to evaluate the effectiveness of MMV compared to SIMV in mechanically ventilated, hemodynamically stable adult patients (>18 years old) in the intensive care unit. Patients must not require vasopressors, have a FiO₂ ≤ 60%, PEEP ≤ 8 cmH₂O, or receive neuromuscular blocking agents.
Patients will be monitored under both SIMV and MMV modes, separated by a 12-hour interval. To minimize carry-over effects, a one-hour washout period will be implemented before data collection with EIT. Key parameters including PO₂/FiO₂ ratio, PaCO₂, and EtCO₂ will be assessed. The sequence of ventilatory mode application will follow a crossover study design.
Read the detailed description
Synchronized Intermittent Mandatory Ventilation (SIMV) and Mandatory Minute Ventilation (MMV) are two established modes of mechanical ventilation commonly used in intensive care settings. SIMV delivers a fixed number of breaths with preset tidal volume or pressure, while allowing the patient to breathe spontaneously between mandatory breaths, enhancing patient-ventilator synchrony. MMV combines features of SIMV and Pressure Support Ventilation (PSV), ensuring a target minute ventilation by supplementing spontaneous efforts when necessary.
Electrical Impedance Tomography (EIT) is a non-invasive, radiation-free imaging modality that provides real-time monitoring of regional lung ventilation and perfusion through surface electrodes. EIT has been validated against conventional imaging and monitoring methods including computed tomography, nitrogen washout, PET, and SPECT. It enables continuous bedside evaluation of ventilation distribution, making it particularly useful for guiding mechanical ventilation strategies in critically ill patients.
This prospective, single-center, crossover study aims to evaluate the effectiveness and physiological impact of MMV compared to SIMV in adult ICU patients who are hemodynamically stable but require mechanical ventilation due to various non-neuromuscular reasons. Inclusion criteria require patients to be over 18 years old, not on vasopressor therapy, with FiO₂ ≤ 60%, and without the need for high PEEP (>8 cmH₂O) or neuromuscular blockade.
Each patient will be ventilated with both SIMV and MMV modes for 12 hours each, with the order of modes randomized using a crossover design. To eliminate carry-over effects, a one-hour washout period will be implemented between mode transitions. During each ventilation mode, EIT will be used to assess real-time regional ventilation distribution. Additionally, gas exchange parameters including PO₂/FiO₂ ratio, PaCO₂, and EtCO₂ will be recorded. The primary objective is to determine whether MMV offers comparable or superior ventilation distribution and gas exchange compared to SIMV in this specific patient population.
- Conditions
- Ventilation Modes, Mechanical Ventilation, Critical Illness, Respiratory Support, Intensive Care Unit (ICU) Patients, Mechanical Ventilation Dependence
- Being tested
- No investigational intervention
- Keywords
- Mechanical Ventilation, SIMV, MMV, Electrical Impedance Tomography, EIT, Intensive Care Unit
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No investigational interventionOther
No investigational intervention. Patients will be observed under standard ventilation modes (SIMV and MMV) as part of routine care.
| Study group | Role | What they receive |
|---|---|---|
| ICU Patients | Hemodynamically stable adult patients (≥18 years) in the intensive care unit who are receiving mechanical ventilation and are eligible to undergo both SIMV and MMV ventilation modes in a crossover observational design. Patients will be monitored using Electrical Impedance Tomography (EIT) under each mode. Receives: Other: No investigational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Regional Ventilation Distribution Measured by Electrical Impedance Tomography (EIT)
Comparison of regional lung ventilation patterns between SIMV and MMV modes in mechanically ventilated ICU patients, assessed by EIT imaging.
Measured: Within 1 hour after initiation of each ventilation mode (SIMV and MMV)
Secondary outcomes (1)
PO₂/FiO₂ Ratio (Oxygenation Index)
Arterial oxygen partial pressure (PaO₂) divided by fraction of inspired oxygen (FiO₂), used to assess oxygenation efficiency under each ventilation mode.
Measured: Measured within 1 hour of each mode (SIMV and MMV)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start10 Mar 2025
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ventilation ModesStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harran University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melahat Yalcin Solak, Harran University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06961227
- Sponsor's protocol ID
- HRÜ.24.20.35
- Status last verified
- Apr 2025
- First submitted
- 29 Apr 2025
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to the limited sample size and the absence of prior consent for data sharing from participants. The collected data is intended solely for internal analysis within the study team.
Publications
Franchineau G, Jonkman AH, Piquilloud L, Yoshida T, Costa E, Roze H, Camporota L, Piraino T, Spinelli E, Combes A, Alcala GC, Amato M, Mauri T, Frerichs I, Brochard LJ, Schmidt M. Electrical Impedance Tomography to Monitor Hypoxemic Respiratory Failure. Am J Respir Crit Care Med. 2024 Mar 15;209(6):670-682. doi: 10.1164/rccm.202306-1118CI.
PubMed 38127779Lobo B, Hermosa C, Abella A, Gordo F. Electrical impedance tomography. Ann Transl Med. 2018 Jan;6(2):26. doi: 10.21037/atm.2017.12.06.
PubMed 29430443Guthrie SO, Lynn C, Lafleur BJ, Donn SM, Walsh WF. A crossover analysis of mandatory minute ventilation compared to synchronized intermittent mandatory ventilation in neonates. J Perinatol. 2005 Oct;25(10):643-6. doi: 10.1038/sj.jp.7211371.
PubMed 16079905
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Ventilation Distribution in Intensive Care: Mandatory Minute Ventilation Versus Synchronized Intermittent Mandatory Ventilation Using Electrical Impedance Tomography"
- ClinicalTrials.gov ID
- NCT06961227
- Acronym / sponsor ID
- HRÜ.24.20.35
- Conditions
- Ventilation Modes, Mechanical Ventilation, Critical Illness, Respiratory Support, Intensive Care Unit (ICU) Patients, Mechanical Ventilation Dependence
- Keywords
- Mechanical Ventilation, SIMV, MMV, Electrical Impedance Tomography, EIT, Intensive Care Unit
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Harran UniversityUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 7 May 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.
Synchronized Intermittent Mandatory Ventilation (SIMV) is a commonly used ventilatory mode available in many modern ventilators, frequently applied in intensive care units for patients requiring invasive mechanical ventilation. SIMV delivers a preset tidal volume or pressure at a predetermined respiratory rate and synchronizes with the patient's spontaneous breathing efforts, thereby enhancing patient-ventilator interaction and contributing to rehabilitation.
Mandatory Minute Ventilation (MMV) is a hybrid mode combining features of SIMV and Pressure Support Ventilation (PSV), guaranteeing a preset minute ventilation (tidal volume × respiratory rate). It synchronizes support based on the patient's spontaneous efforts and compensates in cases of insufficient minute ventilation.
Electrical Impedance Tomography (EIT) is a non-invasive, radiation-free imaging technique that enables real-time monitoring of pulmonary ventilation and perfusion by applying alternating electrical currents through surface electrodes. EIT has demonstrated strong correlation with findings from computed tomography, nitrogen washout, PET, and SPECT imaging modalities.
This study aims to evaluate the effectiveness of MMV compared to SIMV in mechanically ventilated, hemodynamically stable adult patients (>18 years old) in the intensive care unit. Patients must not require vasopressors, have a FiO₂ ≤ 60%, PEEP ≤ 8 cmH₂O, or receive neuromuscular blocking agents.
Patients will be monitored under both SIMV and MMV modes, separated by a 12-hour interval. To minimize carry-over effects, a one-hour washout period will be implemented before data collection with EIT. Key parameters including PO₂/FiO₂ ratio, PaCO₂, and EtCO₂ will be assessed. The sequence of ventilatory mode application will follow a crossover study design.
Detailed description
Synchronized Intermittent Mandatory Ventilation (SIMV) and Mandatory Minute Ventilation (MMV) are two established modes of mechanical ventilation commonly used in intensive care settings. SIMV delivers a fixed number of breaths with preset tidal volume or pressure, while allowing the patient to breathe spontaneously between mandatory breaths, enhancing patient-ventilator synchrony. MMV combines features of SIMV and Pressure Support Ventilation (PSV), ensuring a target minute ventilation by supplementing spontaneous efforts when necessary.
Electrical Impedance Tomography (EIT) is a non-invasive, radiation-free imaging modality that provides real-time monitoring of regional lung ventilation and perfusion through surface electrodes. EIT has been validated against conventional imaging and monitoring methods including computed tomography, nitrogen washout, PET, and SPECT. It enables continuous bedside evaluation of ventilation distribution, making it particularly useful for guiding mechanical ventilation strategies in critically ill patients.
This prospective, single-center, crossover study aims to evaluate the effectiveness and physiological impact of MMV compared to SIMV in adult ICU patients who are hemodynamically stable but require mechanical ventilation due to various non-neuromuscular reasons. Inclusion criteria require patients to be over 18 years old, not on vasopressor therapy, with FiO₂ ≤ 60%, and without the need for high PEEP (>8 cmH₂O) or neuromuscular blockade.
Each patient will be ventilated with both SIMV and MMV modes for 12 hours each, with the order of modes randomized using a crossover design. To eliminate carry-over effects, a one-hour washout period will be implemented between mode transitions. During each ventilation mode, EIT will be used to assess real-time regional ventilation distribution. Additionally, gas exchange parameters including PO₂/FiO₂ ratio, PaCO₂, and EtCO₂ will be recorded. The primary objective is to determine whether MMV offers comparable or superior ventilation distribution and gas exchange compared to SIMV in this specific patient population.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU Patients | – | Other: No investigational interventionHemodynamically stable adult patients (≥18 years) in the intensive care unit who are receiving mechanical ventilation and are eligible to undergo both SIMV and MMV ventilation modes in a crossover observational design. Patients will be monitored using Electrical Impedance Tomography (EIT) under each mode. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years) admitted to the intensive care unit who are intubated and receiving invasive mechanical ventilation. All participants are hemodynamically stable and not receiving vasopressors, high levels of PEEP, or neuromuscular blockers at the time of enrollment.
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Intubated and receiving invasive mechanical ventilation
- Hemodynamically stable (no vasopressor support)
- FiO₂ ≤ 60%
- PEEP ≤ 8 cmH₂O
Key exclusion criteria (7 listed)
- Pregnant or breastfeeding patients
- Patients with neuromuscular diseases affecting respiratory drive
- Unstable hemodynamics or ongoing need for vasopressors
- Patients requiring high PEEP (>8 cmH₂O)
- Patients with DNR (do not resuscitate) status
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 |
|---|---|---|
| No investigational interventionNo investigational intervention. Patients will be observed under standard ventilation modes (SIMV and MMV) as part of routine care. | Other | ICU Patients |
Primary outcome
Change in Regional Ventilation Distribution Measured by Electrical Impedance Tomography (EIT)
Time frame: Within 1 hour after initiation of each ventilation mode (SIMV and MMV)
Comparison of regional lung ventilation patterns between SIMV and MMV modes in mechanically ventilated ICU patients, assessed by EIT imaging.
1 secondary outcome
PO₂/FiO₂ Ratio (Oxygenation Index)
Time frame: Measured within 1 hour of each mode (SIMV and MMV)
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 7 May 2025.
- Results publication: PubMed 38127779Franchineau G, Jonkman AH, Piquilloud L, Yoshida T, Costa E, Roze H, Camporota L, Piraino T, Spinelli E, Combes A, Alcala GC, Amato M, Mauri T, Frerichs I, Brochard LJ, Schmidt M. Electrical Impedance Tomography to Monitor Hypoxemic Respiratory Failure. Am J Respir Crit Care Med. 2024 Mar 15;209(6):670-682. doi: 10.1164/rccm.202306-1118CI.
- Results publication: PubMed 29430443Lobo B, Hermosa C, Abella A, Gordo F. Electrical impedance tomography. Ann Transl Med. 2018 Jan;6(2):26. doi: 10.21037/atm.2017.12.06.
- Results publication: PubMed 16079905Guthrie SO, Lynn C, Lafleur BJ, Donn SM, Walsh WF. A crossover analysis of mandatory minute ventilation compared to synchronized intermittent mandatory ventilation in neonates. J Perinatol. 2005 Oct;25(10):643-6. doi: 10.1038/sj.jp.7211371.
- Individual participant dataSharing planned: No. IPD will not be shared due to the limited sample size and the absence of prior consent for data sharing from participants. The collected data is intended solely for internal analysis within the study team.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilation Modes and Mechanical Ventilation, run by Harran University at 1 site in Turkey (Türkiye).
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 7 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 7 May 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 Turkey (Türkiye). 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 MELAHAT YALÇIN SOLAK, Medical Doctor (+905326479195, melosyalcin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Regional Ventilation Distribution Measured by Electrical Impedance Tomography (EIT) (time frame: Within 1 hour after initiation of each ventilation mode (SIMV and MMV)). 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 NCT06961227, which also lists 3 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 7 May 2025.