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Trial registered on ANZCTR


Registration number
ACTRN12615000205538
Ethics application status
Approved
Date submitted
7/01/2015
Date registered
3/03/2015
Date last updated
15/10/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Determining energy expenditure during critical illness: a comparison of three instruments for indirect calorimetry in mechanically ventilated patients.
Scientific title
In mechanically ventilated adult ICU patients, how well do gas exchange measurements by two indirect calorimetry devices (E-sCOVX and Quark RMR) agree with the reference method (Deltatrac II)?
Secondary ID [1] 285927 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical illness 293854 0
Condition category
Condition code
Metabolic and Endocrine 294156 294156 0 0
Other metabolic disorders
Diet and Nutrition 294157 294157 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All 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. Simultaneous measurements with Deltatrac II and either Quark RMR or E-sCOVX will then be performed in a randomized order. After measuring with the first device, another parallel measurement will be performed with the second device and Deltatrac II. 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.
Intervention code [1] 290903 0
Treatment: Devices
Comparator / control treatment
Energy expenditure as determined by the Deltatrac II is considered the reference method for statistical analysis when compared to the two other devices (E-sCOVX and Quark RMR).
Control group
Active

Outcomes
Primary outcome [1] 293950 0
The primary outcome is the level of agreement between energy expenditure as determined by the two study devices (E-sCOVX, Quark RMR) and the reference method (Deltatrac II).
Timepoint [1] 293950 0
Time of study measurements.
Secondary outcome [1] 312220 0
Respiratory quotient as determined by all three devices (E-sCOVX, Quark RMR, Deltatrac II).
Timepoint [1] 312220 0
Time of study measurements.

Eligibility
Key inclusion criteria
Critically ill patients receiving invasive mechanical ventilation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All ICU patients at the institution that fulfill inclusion criteria during the recruitment period will be screened for participation. Randomisation to order of measurement with different instruments is performed by drawing of sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence generation will be determined by a simple randomisation procedure (computerised sequence generation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
This study is not interventional in nature as the performed measurements will have no effect on determining treatment or outcomes of recruited patients. The data is observational and gathered prospectively. It is listed as such due to the registry form which precludes description of randomization for observational studies.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Limits of agreement and bias between VO2/VCO2 as measured by study instruments (E-sCOVX/Quark RMR) and the reference method (Deltatrac II) will be compared using Bland-Altman plots. Agreement of energy expenditure values as measured by study devices and the reference method will also be compared with the Bland-Altman method, although it is a dependent variable calculated from VO2 and VCO2. A sample size of 50 measurements in at least 20 patients is considered sufficient to determine limits of agreement within +/- 2.0 SD, and coefficients of variation between repeated measurements with the same instrument (n =/>15 for each device).

For descriptive statistics continuous variables with parametric distribution will be analyzed for significance using a two-tailed Student's t-test for paired samples and Mann-Whitney U-test for non-parametric data, an alpha level of =/<0.05 considered as significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/02/2015
Actual
27/02/2015
Date of last participant enrolment
Anticipated
Actual
5/05/2015
Date of last data collection
Anticipated
Actual
5/05/2015
Sample size
Target
50
Accrual to date
Final
48
Recruitment outside Australia
Country [1] 6580 0
Sweden
State/province [1] 6580 0
Stockholm

Funding & Sponsors
Funding source category [1] 290511 0
Government body
Name [1] 290511 0
Regional Agreement on Medical Training and Clinical Research (ALF) between Stockholm County Council and Karolinska Institutet
Country [1] 290511 0
Sweden
Primary sponsor type
Individual
Name
Prof Jan Wernerman
Address
Karolinska Institutet
Inst. for klinisk vetenskap, intervention och teknik
Enheten for anestesi
Karolinska Universitetssjukhuset, Huddinge, K32
141 86 Stockholm
Country
Sweden
Secondary sponsor category [1] 289205 0
None
Name [1] 289205 0
Address [1] 289205 0
Country [1] 289205 0
Other collaborator category [1] 278283 0
Commercial sector/Industry
Name [1] 278283 0
GE Healthcare
Address [1] 278283 0
Kuortanegatan 2
00510
Helsingfors
Finland
Country [1] 278283 0
Finland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292163 0
Regionala etikprovningsnamnden i Stockholm
Ethics committee address [1] 292163 0
Ethics committee country [1] 292163 0
Sweden
Date submitted for ethics approval [1] 292163 0
Approval date [1] 292163 0
24/11/2014
Ethics approval number [1] 292163 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53846 0
Prof Jan Wernerman
Address 53846 0
Karolinska Institutet Inst. for klinisk vetenskap, intervention och teknik Enheten for anestesi Karolinska Universitetssjukhuset, Huddinge, K32 141 86 Stockholm
Country 53846 0
Sweden
Phone 53846 0
+46 8-58586395
Fax 53846 0
Email 53846 0
jan.wernerman@karolinska.se
Contact person for public queries
Name 53847 0
Martin Sundstrom
Address 53847 0
Karolinska Institutet Inst. for klinisk vetenskap, intervention och teknik Enheten for anestesi Karolinska Universitetssjukhuset, Huddinge, K32 141 86 Stockholm
Country 53847 0
Sweden
Phone 53847 0
+46737164623
Fax 53847 0
Email 53847 0
martin.sundstrom@gmail.com
Contact person for scientific queries
Name 53848 0
Martin Sundstrom
Address 53848 0
Karolinska Institutet Inst. for klinisk vetenskap, intervention och teknik Enheten for anestesi Karolinska Universitetssjukhuset, Huddinge, K32 141 86 Stockholm
Country 53848 0
Sweden
Phone 53848 0
+46737164623
Fax 53848 0
Email 53848 0
martin.sundstrom@gmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseMeasuring energy expenditure in the intensive care unit: A comparison of indirect calorimetry by E-sCOVX and Quark RMR with Deltatrac II in mechanically ventilated critically ill patients.2016https://dx.doi.org/10.1186/s13054-016-1232-6
N.B. These documents automatically identified may not have been verified by the study sponsor.