Comparison of the Effects of SIMV-PC and SIMV-VC Ventilation Modes on Resting Energy Expenditure
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.
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Becsült)
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Savaş Altınsoy
- Telefonszám: 05332257104
- E-mail: savasaltinsoy@gmail.com
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Mintavételi módszer
Tanulmányi populáció
Leírás
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.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
Kohorszok és beavatkozások
Csoport / Kohorsz |
Beavatkozás / kezelés |
|---|---|
|
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.
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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.
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Resting energy expenditure (REE) measured by indirect calorimetry.
Időkeret: After being monitored in mechanical ventilation mode (volume or pressure controlled) for 2 hours
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Resting energy expenditure (REE) measured by indirect calorimetry.
|
After being monitored in mechanical ventilation mode (volume or pressure controlled) for 2 hours
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Respiratory rate
Időkeret: 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
Időkeret: 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)
Időkeret: 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
|
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Positive end-expiratory pressure (PEEP)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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
|
Együttműködők és nyomozók
Nyomozók
- Kutatásvezető: Savaş Altınsoy, Ankara Etlik City Hospital
Publikációk és hasznos linkek
Általános kiadványok
- Clapis FC, Auxiliadora-Martins M, Japur CC, Martins-Filho OA, Evora PR, Basile-Filho A. Mechanical ventilation mode (volume x pressure) does not change the variables obtained by indirect calorimetry in critically ill patients. J Crit Care. 2010 Dec;25(4):659.e9-16. doi: 10.1016/j.jcrc.2009.11.010. Epub 2010 Jan 15.
- Chen YH, Hsiao HF, Hsu HW, Cho HY, Huang CC. Comparisons of Metabolic Load between Adaptive Support Ventilation and Pressure Support Ventilation in Mechanically Ventilated ICU Patients. Can Respir J. 2020 Jan 28;2020:2092879. doi: 10.1155/2020/2092879. eCollection 2020.
- dos Santos LJ, Hoff FC, Condessa RL, Kaufmann ML, Vieira SR. Energy expenditure during weaning from mechanical ventilation: is there any difference between pressure support and T-tube? J Crit Care. 2011 Feb;26(1):34-41. doi: 10.1016/j.jcrc.2010.05.032. Epub 2010 Jul 8.
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
Egyéb vizsgálati azonosító számok
- Esra Selçuk Tez
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
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