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Trial registered on ANZCTR


Registration number
ACTRN12616001523493
Ethics application status
Approved
Date submitted
20/10/2016
Date registered
4/11/2016
Date last updated
21/10/2019
Date data sharing statement initially provided
21/10/2019
Date results provided
21/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Validating a new instrument for indirect calorimetry in the ICU: a comparison of gas exchange measurements between BEACON Caresystem and Deltatrac II.
Scientific title
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)?
Secondary ID [1] 290366 0
Nil.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical illness 300655 0
Condition category
Condition code
Metabolic and Endocrine 300510 300510 0 0
Other metabolic disorders
Diet and Nutrition 300511 300511 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 296180 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 study instrument (BEACON Caresystem).
Control group
Active

Outcomes
Primary outcome [1] 299935 0
The primary outcome is the level of agreement between VO2 and VCO2 as determined by the study device (BEACON Caresystem) and the reference method (Deltatrac II).
Timepoint [1] 299935 0
Time of study measurements.
Secondary outcome [1] 328580 0
Respiratory quotient as determined by the study device (BEACON Caresystem) and reference method (Deltatrac II).
Timepoint [1] 328580 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
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Limits of agreement and bias between VO2/VCO2 as measured by the study device (BEACON Caresystem) and reference method (Deltatrac II) will be compared using Bland-Altman plots. Agreement of energy expenditure values as measured by study device 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.

For descriptive statistics continuous variables will be analyzed for statistical significance using a two-tailed Student's t-test for paired samples and Wilcoxon signed-rank test as appropriate. An alpha level of =/<0.05 is considered significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/11/2016
Actual
10/11/2016
Date of last participant enrolment
Anticipated
Actual
10/10/2018
Date of last data collection
Anticipated
Actual
10/10/2018
Sample size
Target
50
Accrual to date
Final
49
Recruitment outside Australia
Country [1] 8338 0
Sweden
State/province [1] 8338 0
Stockholm

Funding & Sponsors
Funding source category [1] 294749 0
Government body
Name [1] 294749 0
Regional Agreement on Medical Training and Clinical Research (ALF) between Stockholm County Council and Karolinska Institutet
Country [1] 294749 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] 293601 0
None
Name [1] 293601 0
Address [1] 293601 0
Country [1] 293601 0
Other collaborator category [1] 279270 0
Commercial sector/Industry
Name [1] 279270 0
Mermaid Care A/S
Address [1] 279270 0
Hedelund 1
DK-9400 Nr. Sundby
Denmark
Country [1] 279270 0
Denmark

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296166 0
Regionala etikprovningsnamnden i Stockholm
Ethics committee address [1] 296166 0
Ethics committee country [1] 296166 0
Sweden
Date submitted for ethics approval [1] 296166 0
30/09/2016
Approval date [1] 296166 0
26/10/2016
Ethics approval number [1] 296166 0

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

Contacts
Principal investigator
Name 69826 0
Prof Jan Wernerman
Address 69826 0
Karolinska Institutet Inst. for klinisk vetenskap, intervention och teknik Enheten for anestesi Karolinska Universitetssjukhuset, Huddinge, K32 141 86 Stockholm
Country 69826 0
Sweden
Phone 69826 0
+46 8-58586395
Fax 69826 0
Email 69826 0
jan.wernerman@karolinska.se
Contact person for public queries
Name 69827 0
Martin Sundstrom Rehal
Address 69827 0
Karolinska Institutet Inst. for klinisk vetenskap, intervention och teknik Enheten for anestesi Karolinska Universitetssjukhuset, Huddinge, K32 141 86 Stockholm
Country 69827 0
Sweden
Phone 69827 0
+46737164623
Fax 69827 0
Email 69827 0
martin.sundstrom@gmail.com
Contact person for scientific queries
Name 69828 0
Martin Sundstrom Rehal
Address 69828 0
Karolinska Institutet Inst. for klinisk vetenskap, intervention och teknik Enheten for anestesi Karolinska Universitetssjukhuset, Huddinge, K32 141 86 Stockholm
Country 69828 0
Sweden
Phone 69828 0
+46737164623
Fax 69828 0
Email 69828 0
martin.sundstrom@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All de-identified patient data collected within the frame of this study will be available on request.
When will data be available (start and end dates)?
Start date after publication (to be determined), no end date determined.
Available to whom?
IPD will be made available to any non-commercial interests on reasonable request to the corresponding author Panuwat Promsin by e-mail (artpnw@gmail.com).
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
IPD will be made available to any non-commercial interests on reasonable request to the corresponding author Panuwat Promsin by e-mail (artpnw@gmail.com).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5150Ethical approval  artpnw@gmail.com
5368Study protocol  artpnw@gmail.com
5369Informed consent form  artpnw@gmail.com



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.