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

24 agosto 2026 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

41

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Resting energy expenditure (REE) measured by indirect calorimetry.
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Respiratory rate
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Savaş Altınsoy, Ankara Etlik City Hospital

Pubblicazioni e link utili

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Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

30 agosto 2026

Completamento primario (Stimato)

15 dicembre 2026

Completamento dello studio (Stimato)

15 gennaio 2027

Date di iscrizione allo studio

Primo inviato

7 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

24 agosto 2026

Primo Inserito (Effettivo)

27 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

27 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • Esra Selçuk Tez

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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