Condition category
Not Applicable
Date applied
10/07/2019
Date assigned
11/07/2019
Last edited
11/07/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Wolfgang Huber

ORCID ID

http://orcid.org/0000-0001-9086-7908

Contact details

Medizinische Klinik und Poliklinik II
Klinikum rechts der Isar
Technische Universität München
Munich
D-81675
Ghana
+49 (0)16097528262
wolfgang.huber@tum.de

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Body surface and core temperatures to assess haemodynamics in critically ill patients

Acronym

BOSTON

Study hypothesis

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

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

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

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Condition

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

Phase

Drug names

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 trial start date

01/07/2009

Overall trial end date

21/12/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Haemodynamic monitoring with transpulmonary thermodilution (PiCCO) according to the local standard and irrespective of the study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Cumulative number: n=500; per sub-study n=30 to n=80

Participant exclusion criteria

Contra-indications for PiCCO-monitoring

Recruitment start date

25/08/2009

Recruitment end date

30/09/2021

Locations

Countries of recruitment

Germany

Trial participating centre

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

Sponsor information

Organisation

Technische Universität München

Sponsor details

Medizinische Klinik und Poliklinik II
Klinikum rechts der Isar
Munich
D-81675
Germany
+49 (0)16097528262
wolfgang.huber@tum.de

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Technische Universität München

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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 statement
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.

Intention to publish date

30/09/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

11/07/2019: Trial's existence confirmed by ethics committee.