- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06961227
- Original Trial
Effectiveness of Ventilation Modes in Intensive Care: A Comparison of Mandatory Minute Ventilation and Synchronized Intermittant Mandatory Ventilation Using Bioelectrical Impedance Tomography
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: MELAHAT YALÇIN SOLAK, Medical Doctor
- Phone Number: +905326479195
- Email: melosyalcin@gmail.com
Study Locations
-
-
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Şanlıurfa, Turkey, 63000
- Recruiting
- Harran University Faculty of Medicine, Department of Anesthesiology and Reanimation
-
Contact:
- Evren BÜYÜKFIRAT, Medical Doctor
- Phone Number: +905065849686
- Email: evrenbf@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
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
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Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
No investigational intervention.
Patients will be observed under standard ventilation modes (SIMV and MMV) as part of routine care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Within 1 hour after initiation of each ventilation mode (SIMV and MMV)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PO₂/FiO₂ Ratio (Oxygenation Index)
Time Frame: Measured within 1 hour of each mode (SIMV and MMV)
|
Arterial oxygen partial pressure (PaO₂) divided by fraction of inspired oxygen (FiO₂), used to assess oxygenation efficiency under each ventilation mode.
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Measured within 1 hour of each mode (SIMV and MMV)
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Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- Lobo 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.
- Guthrie 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HRÜ.24.20.35
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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