Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:27 AM
Study NCT ID:
NCT06961227
Status:
RECRUITING
Last Update Posted:
2025-05-07
First Post:
2025-04-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Ventilation Modes in Intensive Care: A Comparison of Mandatory Minute Ventilation and Synchronized Intermittant Mandatory Ventilation Using Bioelectrical Impedance Tomography
Sponsor:
Harran University
Organization:
Study Overview
Official Title:
Comparative Analysis of Ventilation Distribution in Intensive Care: Mandatory Minute Ventilation Versus Synchronized Intermittent Mandatory Ventilation Using Electrical Impedance Tomography"
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: