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

2026年8月24日 更新者:Savas Altinsoy、Diskapi Yildirim Beyazit Education and Research Hospital

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

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.

調査の概要

詳細な説明

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.

研究の種類

観察的

入学 (推定)

41

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

Receiving invasive mechanical ventilation in the intensive care unit. Receiving continuous enteral nutrition during indirect calorimetry measurements.

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
Monitored with mechanical ventilation patients
In intensive care patients monitored with mechanical ventilation, energy consumption will be monitored using indirect calorimetry after volume-controlled or pressure-controlled ventilation.
In intensive care patients monitored with mechanical ventilation, energy consumption will be monitored using indirect calorimetry after volume-controlled ventilation.
In intensive care patients monitored with mechanical ventilation, energy consumption will be monitored using indirect calorimetry after pressure-controlled ventilation.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Resting energy expenditure (REE) measured by indirect calorimetry.
時間枠:After being monitored in mechanical ventilation mode (volume or pressure controlled) for 2 hours
Resting energy expenditure (REE) measured by indirect calorimetry.
After being monitored in mechanical ventilation mode (volume or pressure controlled) for 2 hours

二次結果の測定

結果測定
メジャーの説明
時間枠
Respiratory rate
時間枠:After being monitored in mechanical ventilation mode (volume or pressure controlled) for 2 hours
Respiratory rate
After being monitored in mechanical ventilation mode (volume or pressure controlled) for 2 hours
Tidal volume
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Savaş Altınsoy、Ankara Etlik City Hospital

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年8月30日

一次修了 (推定)

2026年12月15日

研究の完了 (推定)

2027年1月15日

試験登録日

最初に提出

2026年8月7日

QC基準を満たした最初の提出物

2026年8月24日

最初の投稿 (実際)

2026年8月27日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月27日

QC基準を満たした最後の更新が送信されました

2026年8月24日

最終確認日

2026年8月1日

詳しくは

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個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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いいえ

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いいえ

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