Effectiveness of Ventilation Modes in Intensive Care: A Comparison of Mandatory Minute Ventilation and Synchronized Intermittant Mandatory Ventilation Using Bioelectrical Impedance Tomography

NCT06961227 | Recruiting

• 1 other identifier: HRÜ.24.20.35
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilation Modes; Mechanical Ventilation; Critical Illness; Respiratory Support; Intensive Care Unit (ICU) Patients; Mechanical Ventilation Dependence; Evaluation of Mechanical Ventilation Modes (SIMV and MMV) in Adult Intensive Care Unit Patients Using Electrical Impedance Tomography

Keywords

Mechanical Ventilation; SIMV; MMV; Electrical Impedance Tomography; EIT; Intensive Care Unit

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 1 hour after initiation of each ventilation mode (SIMV and MMV)

Secondary Outcomes (1)

• PO₂/FiO₂ Ratio (Oxygenation Index)

  Measured within 1 hour of each mode (SIMV and MMV)

Study Arms (1)

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.

Other: No investigational intervention

Interventions

No investigational intervention OTHER

No investigational intervention. Patients will be observed under standard ventilation modes (SIMV and MMV) as part of routine care.

ICU Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Harran University: lead

Study Sites (1)

Harran University Faculty of Medicine, Department of Anesthesiology and Reanimation

Sanliurfa, 63000, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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.

  PMID: 38127779 BACKGROUND

• 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.

  PMID: 29430443 BACKGROUND

• 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.

  PMID: 16079905 BACKGROUND

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

MELAHAT YALÇIN SOLAK, Medical Doctor

CONTACT

+905326479195; melosyalcin@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer Doctor

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 7, 2025
• Study Start: March 10, 2025
• Primary Completion: September 30, 2025
• Study Completion: October 31, 2025
• Last Updated: May 7, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)