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

NCT07790341 | Not Yet Recruiting

• 1 other identifier: Esra Selçuk Tez
• Study Type: observational
• Target: 41
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Resting Energy Expenditure; Indirect Calorimetry

Keywords

Resting energy expenditure; Pressure-controlled mode (SIMV-PC); Volume-controlled mode (SIMV-VC)

Outcome Measures

Primary Outcomes (1)

• Resting energy expenditure (REE) measured by indirect calorimetry.

  Resting energy expenditure (REE) measured by indirect calorimetry.

  After being monitored in mechanical ventilation mode (volume or pressure controlled) for 2 hours

Secondary Outcomes (9)

• Respiratory rate

  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)

  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)

  After being monitored in mechanical ventilation mode (volume or pressure controlled) for 2 hours

Study Arms (1)

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.

Other: Volume-controlled ventilation; Other: Pressure-controlled ventilation

Interventions

Volume-controlled ventilation OTHER

In intensive care patients monitored with mechanical ventilation, energy consumption will be monitored using indirect calorimetry after volume-controlled ventilation.

Monitored with mechanical ventilation patients

Pressure-controlled ventilation OTHER

In intensive care patients monitored with mechanical ventilation, energy consumption will be monitored using indirect calorimetry after pressure-controlled ventilation.

Monitored with mechanical ventilation patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Diskapi Yildirim Beyazit Education and Research Hospital: lead

Related Publications (3)

• 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.

  PMID: 20080021 BACKGROUND

• 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.

  PMID: 32076468 RESULT

• 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.

  PMID: 20619600 RESULT

Study Officials

• Savaş Altınsoy

  Ankara Etlik City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Savaş Altınsoy

CONTACT

05332257104; savasaltinsoy@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 27, 2026
• Study Start: August 30, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): January 15, 2027
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share