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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 41
- 主要终点
- Resting energy expenditure (REE) measured by indirect calorimetry.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •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.
结局指标
主要结局
Resting energy expenditure (REE) measured by indirect calorimetry.
时间窗: After being monitored in mechanical ventilation mode (volume or pressure controlled) for 2 hours
Resting energy expenditure (REE) measured by indirect calorimetry.
次要结局
- Respiratory rate(After being monitored in mechanical ventilation mode (volume or pressure controlled) for 2 hours)
- Tidal volume(After being monitored in mechanical ventilation mode (volume or pressure controlled) for 2 hours)
- Peak inspiratory pressure (Ppeak)(After being monitored in mechanical ventilation mode (volume or pressure controlled) for 2 hours)
- Positive end-expiratory pressure (PEEP)(After being monitored in mechanical ventilation mode (volume or pressure controlled) for 2 hours)
- Fraction of inspired oxygen (FiO₂)(After being monitored in mechanical ventilation mode (volume or pressure controlled) for 2 hours)
- Arterial blood gas parameters (pH)(After being monitored in mechanical ventilation mode (volume or pressure controlled) for 2 hours)
- Arterial blood gas parameters (PaCO₂)(After being monitored in mechanical ventilation mode (volume or pressure controlled) for 2 hours)
- Arterial blood gas parameters (PaO₂)(After being monitored in mechanical ventilation mode (volume or pressure controlled) for 2 hours)
- Arterial blood gas parameters (Lactate)(After being monitored in mechanical ventilation mode (volume or pressure controlled) for 2 hours)
研究者
Savas Altinsoy
Principal Investigator
Diskapi Yildirim Beyazit Education and Research Hospital