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Validating a new instrument for indirect calorimetry in the ICU: a comparison of gas exchange measurements between BEACON Caresystem and Deltatrac II.

In mechanically ventilated adult ICU patients, how well does gas exchange measurement by a new device for indirect calorimetry (BEACON Caresystem) agree with the reference method (Deltatrac II)?

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616001523493
Enrollment
49
Registered
2016-11-04
Start date
2016-11-10
Completion date
2018-10-10
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Critical illness is characterized by a catabolic state and loss of lean body mass. It has been hypothesized that this process can be attenuated by nutritional therapies, but the optimal energy delivery for this heterogenous patient population remains unknown. Indirect calorimetry can accurately determine energy expenditure in individual patients, but previous studies (Sundstrom Rehal et al, Crit Care. 2016;20:54, Sundstrom et al, Clin Nutr. 2013 Feb;32(1), Graf et al Clin Nutr. 2014 Jan 21) have demonstrated varying agreement between instruments. Deltatrac II (Datex-Ohmeda, Helsinki, Finland) has historically been considered the gold standard for gas exchange measurements in intensive care but is no longer in production. The aim of this study is to determine the level of agreement of gas exchange measurements between two devices for indirect calorimetry in mechanically ventilated ICU patients: BEACON Caresystem (Mermaid Care, Nr. Sundby, Denmark) and Deltatrac II. We hypothesize that both instruments measure oxygen comsumption (VO2) and carbon dioxide production (VCO2) with equal precision and accuracy.

Interventions

Both study instruments will be connected in parallel, a mandatory 10 minute period is then provided before commencement of gas exchange measurements to allow the Deltatrac mixing chamber to equilibrate with expired gas from the patient after the initial break in the ventilator circuit during connection. A simultaneous measurement with Deltatrac II and BEACON Caresystem will then be performed. Average values for energy expenditure (EE), VO2, VCO2, minute ventilation (MV) and respiratory quotient

Both study instruments will be connected in parallel, a mandatory 10 minute period is then provided before commencement of gas exchange measurements to allow the Deltatrac mixing chamber to equilibrate with expired gas from the patient after the initial break in the ventilator circuit during connection. A simultaneous measurement with Deltatrac II and BEACON Caresystem will then be performed. Average values for energy expenditure (EE), VO2, VCO2, minute ventilation (MV) and respiratory quotient (RQ) will be registered after a 20 minute period. Measurements where the reference method registers a mean RQ of <0.6 or >1.2 will be discarded. All aspects of the patient's ICU therapy are determined by the attending physician. Changes in ventilator settings, disconnection of the ventilator circuit or patient mobilization are to be avoided during and one hour previous to measurements unless deemed necessary by medical staff. In such event the ongoing measurement will be discontinued and restarted after a 15 minute resting period. Patients can be measured on multiple occasions given a minimum interval of one calendar day.

Sponsors

Prof Jan Wernerman
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Critically ill patients receiving invasive mechanical ventilation.

Exclusion criteria

Fraction of inspired oxygen concentration >0.6, respiratory rate >35, uncontrolled gas leaks in ventilatory circuit (chest drains, pneumothorax, bronchoesophageal fistula), leak in ventilator circuit >10% of minute volume, ECMO/NO-therapy, absence of informed consent by patient or relative.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026