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

2026년 8월 24일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

관찰

등록 (추정된)

41

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

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

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Resting energy expenditure (REE) measured by indirect calorimetry.
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Respiratory rate
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Savaş Altınsoy, Ankara Etlik City Hospital

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 8월 30일

기본 완료 (추정된)

2026년 12월 15일

연구 완료 (추정된)

2027년 1월 15일

연구 등록 날짜

최초 제출

2026년 8월 7일

QC 기준을 충족하는 최초 제출

2026년 8월 24일

처음 게시됨 (실제)

2026년 8월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 27일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 24일

마지막으로 확인됨

2026년 8월 1일

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