Body surface and core temperatures and their association with cardiac function

ISRCTN	ISRCTN17182512
DOI	https://doi.org/10.1186/ISRCTN17182512
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Nil known
Sponsor	Technische Universität München
Funder	Technische Universität München

Submission date: 10/07/2019
Registration date: 11/07/2019
Last edited: 21/02/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Assessment of peripheral perfusion (blood flow) and comparison of surface and body core temperature (BST; BCT) are diagnostic cornerstones of critical care. Infrared non-contact thermometers provide easy and accurate measurement of BST. In clinical routine BCT is most frequently measured with ear thermometers in an intermittent way. The PiCCO device provides accurate measurement of Cardiac Index using an arterial line with a thermistor tip which is introduced into the distal aorta. Irrespectively of intermittent CI measurement, the PiCCO catheter provides continuous measurement of BCT.

Who can participate?
Patients in the intensive care unit undergoing transpulmonary thermodilution (PiCCO) monitoring

What does the study involve?
Repeated measurement of body surface and core temperatures as well as repeated measurement of cardiac index.

What are the possible benefits and risks of participating?
Patients may benefit from more intense monitoring during the study period. All methods are routine techniques with limited risks. Non-contact infrared thermometers are considered safe even when used by lays.

Where is the study run from?
Intensive Care Unit of Klinikum rechts der Isar; Technische Universität München (Germany)

When is the study starting and how long is it expected to run for?
July 2009 to December 2021

Who is funding the study?
Technische Universität München (Germany)

Who is the main contact?
Prof. Dr. Wolfgang Huber
wolfgang.huber@tum.de

Contact information

Prof Wolfgang Huber
Scientific

Medizinische Klinik und Poliklinik II
Klinikum rechts der Isar
Technische Universität München
Munich
D-81675
Ghana

ORCID ID	0000-0001-9086-7908
Phone	+49 (0)16097528262
Email	wolfgang.huber@tum.de

Study information

Primary study design	Observational
Study design	Study bundle with more than 10 sub-studies (BOSTON-I; BOSTON-II; BOSTON-III etc.). All studies have in common that Goldstandard Cardiac Index and Body core temperature (BCT) is measured with transpulmonary thermodilution (PiCCO; Pulsion Medical Systems SE; Feldkirchen; Germany), and Body Surface temperature is measured with a non-contact infrared Thermometer (Thermofocus or Visoofocus; Tecnimed; Varese; Italy). In Addition other less or non-invasive devices to assess CI (e.g. FloTrac; Edwards Lifesciences; Irvine; USA; ProAqt; Pulsion Medical Systems SE; Feldkirchen, Germany; ClearSight; Edwards Lifesciences; Irvine; USA); are compared with CI derived from thermodilution (PiCCO: CI_TD) and CI derived from BST (CI_BST).
Secondary study design	Cohort study
Scientific title	Body surface and core temperatures to assess haemodynamics in critically ill patients
Study acronym	BOSTON
Study objectives	Body surface temperatures, body core temperatures, structured clinical examination and biochemical markers such as ScvO2 and Lactate - alone and in combination - might be useful to estimate Cardiac Index (CI).
Ethics approval(s)	Approved 19/06/2012 (Project 5384/12), 30/12/2011 (Project 501/11), 18/04/2017 (Project 3049/11s), Ethikkommission der Technischen Universität München (Fakultät für Medizin. Ismaningerstrasse 22. D-81675 München, Tel: +49 (0)89 4140 7737; Email: ethikkommission@mri.tum.de), ref: 3049/11s; 5101/11; 5384/12
Health condition(s) or problem(s) studied	Critical care patients at risk of shock
Intervention	The main intervention is to observe the association of body surface temperatures measured with a non-contact infrared Thermometer (Thermofocus) with body core temperatures measured with a Thermistor-equipped arterial catheter (PiCCO; Pulsion Medical Systems SE; Feldkirchen; Germany), with a Thermistor-tipped urinary catheter (Urosid Sensor 400; ASID BONZ; Herrenberg; Germany) and an ear Thermometer (ThermoScan; Braun; Melsungen; Germany) and with cardiac index derived from transpulmonary thermodilution (PiCCO; Pulsion Medical Systems SE; Feldkirchen; Germany) and less invasive devices to estimate cardiac index. Measurements and comparisons are performed between 2 and 8 times within one and five days.
Intervention type	Other
Primary outcome measure(s)	1. Body surface temperatures measured with a non-contact infrared Thermometer (Thermofocus) 2. Body core temperatures measured with a Thermistor-equipped arterial catheter (PiCCO; Pulsion Medical Systems SE; Feldkirchen; Germany), with a Thermistor-tipped urinary catheter (Urosid Sensor 400; ASID BONZ; Herrenberg; Germany) and an ear Thermometer (ThermoScan; Braun; Melsungen; Germany) 3. Cardiac index derived from transpulmonary thermodilution (PiCCO; Pulsion Medical Systems SE; Feldkirchen; Germany) and less invasive devices (e.g. FloTrac, ProAqt, ClearSight) Body surface temperatures, body core temperatures and cardiac index are measured between 2 and 8 times within one and five days. The typical schedule for comparisons of estimates of cardiac index based on body surface temperatures or less invasive devices with gold standard measurement of cardiac index with the PiCCO device is based on eight measurements within 24 h (0:00 h; 0:30 h; 2:00 h; 4:30 h; 8:00 h; 20:00 h; 23:30 h; 24:00 h).
Key secondary outcome measure(s)	There are no secondary outcome measures
Completion date	21/12/2021

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	500
Key inclusion criteria	Haemodynamic monitoring with transpulmonary thermodilution (PiCCO) according to the local standard and irrespective of the study
Key exclusion criteria	Contra-indications for PiCCO-monitoring
Date of first enrolment	25/08/2009
Date of final enrolment	30/09/2021

Locations

Countries of recruitment

Germany

Study participating centre

Technische Universität München

Medizinische Klinik und Poliklinik II
Klinikum rechts der Isar
Munich
D-81675
Germany

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	Due to ethical and legal restrictions imposed by Ethikkommission der Fakultät für Medizin der Technischen Universität München, confidential data are available upon request. To receive anonymized data readers are welcome to contact the corresponding author (Prof. Dr. Wolfgang Huber, II. Medizinische Klinik und Poliklinik, Klinikum rechts der Isar der Technischen Universität München, Ismaninger Strasse 22, D-81675 München, Germany; Wolfgang.Huber@tum.de). Data will be available after final publication for up to 5 years.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Interim results article	BOSTON-I-study	14/11/2019	21/02/2024	Yes	No

Editorial Notes

21/02/2024: Publication reference added.
11/07/2019: Trial's existence confirmed by ethics committee.