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NCT Number: NCT07790341

Comparison of the Effects of SIMV-PC and SIMV-VC Ventilation Modes on Resting Energy Expenditure

The primary objective of this prospective observational study is to compare the effects of synchronized intermittent mandatory ventilation in pressure-controlled mode (SIMV-PC) and volume-controlled mode (SIMV-VC) on resting energy expenditure (REE) measured by indirect calorimetry in adult intensive care unit (ICU) patients receiving invasive mechanical ventilation.

The primary metabolic parameters to be evaluated are oxygen consumption (VO₂), carbon dioxide production (VCO₂), resting energy expenditure (REE), and respiratory quotient (RQ). Secondary objectives include comparison of respiratory rate, tidal volume, minute ventilation,arterial blood gas parameters, mechanical power, ventilator mechanics, hemodynamic variables, sedation level, and patient-ventilator synchrony between the two ventilation modes.

The results of this study may contribute to identifying ventilation strategies associated with lower energy expenditure while maintaining adequate ventilatory support in critically ill patients and may help optimize individualized ventilator management and nutritional therapy.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

Mechanical ventilation is a cornerstone of supportive therapy in critically ill patients. Although synchronized intermittent mandatory ventilation in pressure-controlled (SIMV-PC) and volume-controlled (SIMV-VC) modes are widely used in routine intensive care practice, limited data are available regarding their effects on patients' energy expenditure measured by indirect calorimetry.

Indirect calorimetry is recommended by the European Society for Clinical Nutrition and Metabolism (ESPEN) as the reference standard for determining energy expenditure in critically ill patients. Accurate estimation of energy expenditure is essential for optimizing nutritional therapy and avoiding both underfeeding and overfeeding. Overfeeding may increase carbon dioxide production, insulin requirements, respiratory workload, duration of mechanical ventilation, and intensive care unit length of stay.

This is a prospective, observational, repeated-measures study conducted in adult ICU patients receiving invasive mechanical ventilation. The study is non-interventional. Ventilation mode selection and all ventilator adjustments will be determined exclusively by the attending intensive care physician according to routine clinical practice. No study-specific ventilator changes, additional invasive procedures, or additional blood sampling will be performed.

Indirect calorimetry measurements will be performed during clinically stable periods under routine ICU monitoring. Measurements will be obtained only after at least 30 minutes of stabilization following any clinically indicated ventilation mode change. Patients receiving continuous enteral nutrition with no major changes in sedative or analgesic infusions during the preceding two hours will be eligible for metabolic measurements. Sedation level will be documented using the Richmond Agitation-Sedation Scale (RASS).

Metabolic parameters obtained by indirect calorimetry, including oxygen consumption (VO₂), carbon dioxide production (VCO₂), resting energy expenditure (REE), and respiratory quotient (RQ), will be compared between SIMV-PC and SIMV-VC ventilation modes. Ventilator parameters, respiratory mechanics, mechanical power, arterial blood gas findings, hemodynamic variables, and patient-ventilator synchrony will also be evaluated.

Because the study is observational and based entirely on routine clinical care, no additional risks beyond standard intensive care management are anticipated. If hemodynamic or respiratory instability develops during indirect calorimetry measurements, the measurement will be discontinued immediately and routine patient management will continue according to the attending physician's clinical judgment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18 to 80 years.
  • Receiving invasive mechanical ventilation in the intensive care unit.
  • Receiving continuous enteral nutrition during indirect calorimetry measurements.
  • Hemodynamically stable (mean arterial pressure ≥65 mmHg without significant increase in vasopressor requirement).
  • Technically suitable for indirect calorimetry measurements.
  • Written informed consent obtained from the patient or the legally authorized representative.

Exclusion criteria

  • Age <18 years or >80 years.
  • Pregnancy.
  • Hemodynamic instability.
  • High vasopressor requirement or marked increase in vasopressor dosage.
  • Requirement for frequent or major changes in ventilator settings or FiO₂.
  • FiO₂ >0.60.
  • Bronchopleural fistula, significant air leak, or other pulmonary conditions interfering with indirect calorimetry.
  • Extracorporeal membrane oxygenation (ECMO).
  • Continuous renal replacement therapy (CRRT).
  • Significant body temperature fluctuations.
  • Active agitation or severe patient-ventilator dyssynchrony.
  • Acute metabolic changes that may interfere with indirect calorimetry measurements.

Treatment and study plan

Volume-controlled ventilation

Other

In intensive care patients monitored with mechanical ventilation, energy consumption will be monitored using indirect calorimetry after volume-controlled ventilation.

Pressure-controlled ventilation

Other

In intensive care patients monitored with mechanical ventilation, energy consumption will be monitored using indirect calorimetry after pressure-controlled ventilation.

Primary outcomes

  1. Resting energy expenditure (REE) measured by indirect calorimetry.

    Time frame: After being monitored in mechanical ventilation mode (volume or pressure controlled) for 2 hours

    Resting energy expenditure (REE) measured by indirect calorimetry.

Secondary outcomes

  1. Respiratory rate

    Time frame: After being monitored in mechanical ventilation mode (volume or pressure controlled) for 2 hours

    Respiratory rate

  2. Tidal volume

    Time frame: After being monitored in mechanical ventilation mode (volume or pressure controlled) for 2 hours

    Tidal volume

  3. Peak inspiratory pressure (Ppeak)

    Time frame: After being monitored in mechanical ventilation mode (volume or pressure controlled) for 2 hours

    Peak inspiratory pressure (Ppeak)

  4. Positive end-expiratory pressure (PEEP)

    Time frame: After being monitored in mechanical ventilation mode (volume or pressure controlled) for 2 hours

    Positive end-expiratory pressure (PEEP)

  5. Fraction of inspired oxygen (FiO₂)

    Time frame: After being monitored in mechanical ventilation mode (volume or pressure controlled) for 2 hours

    Fraction of inspired oxygen (FiO₂)

  6. Arterial blood gas parameters (pH)

    Time frame: After being monitored in mechanical ventilation mode (volume or pressure controlled) for 2 hours

    Arterial blood gas parameters (pH)

  7. Arterial blood gas parameters (PaCO₂)

    Time frame: After being monitored in mechanical ventilation mode (volume or pressure controlled) for 2 hours

    Arterial blood gas parameters (PaCO₂)

  8. Arterial blood gas parameters (PaO₂)

    Time frame: After being monitored in mechanical ventilation mode (volume or pressure controlled) for 2 hours

    Arterial blood gas parameters (PaO₂)

  9. Arterial blood gas parameters (Lactate)

    Time frame: After being monitored in mechanical ventilation mode (volume or pressure controlled) for 2 hours

    Arterial blood gas parameters (Lactate)

Study contacts

Contact information is provided by the study sponsor or research team.

Savaş Altınsoy

CONTACT

[email protected]

05332257104

Sponsors and collaborators

Lead sponsor

Diskapi Yildirim Beyazit Education and Research Hospital

Other Gov

Registry information

Official study title

Comparison of the Effects of SIMV-PC and SIMV-VC Ventilation Modes on Resting Energy Expenditure Measured by Indirect Calorimetry and Mechanical Power in Adult Intensive Care Unit Patients Receiving Invasive Mechanical Ventilation

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Aug 27, 2026
Registry last updated
Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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