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

24. august 2026 opdateret af: 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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

41

Kontakter og lokationer

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Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

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Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Resting energy expenditure (REE) measured by indirect calorimetry.
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Respiratory rate
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Samarbejdspartnere og efterforskere

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Efterforskere

  • Ledende efterforsker: Savaş Altınsoy, Ankara Etlik City Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

30. august 2026

Primær færdiggørelse (Anslået)

15. december 2026

Studieafslutning (Anslået)

15. januar 2027

Datoer for studieregistrering

Først indsendt

7. august 2026

Først indsendt, der opfyldte QC-kriterier

24. august 2026

Først opslået (Faktiske)

27. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • Esra Selçuk Tez

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