Body surface and core temperatures and their association with cardiac function
| ISRCTN | ISRCTN17182512 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17182512 |
- 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
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
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 |
| wolfgang.huber@tum.de |
Study information
| 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). |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| 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 | 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). |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/07/2009 |
| Completion date | 21/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Cumulative number: n=500; per sub-study n=30 to n=80 |
| 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
Klinikum rechts der Isar
Munich
D-81675
Germany
Sponsor information
University/education
Medizinische Klinik und Poliklinik II
Klinikum rechts der Isar
Munich
D-81675
Germany
| Phone | +49 (0)16097528262 |
|---|---|
| wolfgang.huber@tum.de | |
"ROR" |
https://ror.org/02kkvpp62 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 30/09/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | 1. All results will be submitted to peer-reviewed journals 2 The results of BOSTON-I and BOSTON-II will be submitted in July 2019 3. Preliminary results of BOSTON-III to BOSTON-VII have been presented on international critical care congresses (ESICM; SCCM; ISICEM) |
| 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.
