COST
COST Action B 14
HYPERBARIC OXYGEN THERAPY
FINAL EVALUATION REPORT
Period: from December 1998 to March 2005
Overview
Action Identification Data
COST Action B14 Hyperbaric Oxygen Therapy
TC Recommendation: First MC meeting: 19 March 1999
CSO Approval: 25 June 1998 Last MC meeting: 4 December 2004
Start date: 9 December 1998 Final Report: 10 March 2006
Duration: 60 months Evaluation Report:
Extension: 15 months TC Evaluation:
End date: 8 March 2005
Number of signatories: 19
Signatories and date of signature:
Austria: 9 December 1998 Greece: 18 December 1998 Poland: 9 March 1999
Belgium: 9 December 1998 Hungary Portugal: 26 April 1999
Bulgaria Iceland Romania
Croatia Israel: 19 December 2000 Slovakia
Cyprus: 17 July 2001 Ireland Slovenia: 9 December 1998
Czech Rep: 12 May 2000 Italy: 5 May 1999 Spain: 13 January 1999
Denmark: 9 December 1998 Latvia Sweden: 24 February 1999
Estonia Lithuania Switzerland: 9 December 1998
Finnland : 9 June 1999 Luxembourg Turkey
France: 8 March 2000 Malta United Kingdom:
Germany: 9 December 1998 Netherlands: 10 February 1999 9 December 1998
Institutes of non-COST countries:
Area: Medicine and Health
Action Web site : http://www.oxynet.org
Chairperson : Professor Daniel MATHIEU
Professor D. MATHIEU Tel : 333 20 44 54 91
Centre Régional Hyperbare Fax : 333 20 44 43 17
CHRU de Lille E-Mail : dmathieu@chru-lille.fr
Bd du Pr. Leclercq
F-59307 Lille Cedex
TC Rapporteur :
External Evaluator :
External Evaluator :
‚ Objectives
Hyperbaric Oxygen Therapy (HBOT) is a treatment modality using oxygen breathed under high pressure. The expected therapeutic benefits are: increase in diffusion of oxygen into tissues adjacent to the microcirculation and thus, the survival of cells otherwise insufficiently oxygenated, generalised arteriolar vasoconstriction, anti-infectious effects, promotion of healing.
Introduced in the medical therapeutic armament in the early sixties, HBOT has been widely used before its development became restrained by an insufficient pathophysiological knowledge and some technical concerns.
The main objective of the Action is to improve the knowledge required for a rational use of HBOT, to a level making it possible to set out specific guidelines for the implementation and development of clinical HBOT centres and to provide scientifically sound recommendations for HBOT treatment of various diseases and conditions.
ƒ Technical description and implementation
The COST Action B14 « Hyperbaric Oxygen Therapy » is managed for all its official aspects by a Management Committee which is responsible for the determination of the overall strategy, approval of working group reports and decisions, attribution of short term scientific missions, official reports and meeting organisation.
As proposed in the MoU, the COST B14 Action has been implemented through 3 working groups (WG) devoted to the development of :
- a « Information Network », to be maintained throughout the duration of the Action. It consists in an Internet Website, allowing the easy retrieval of information, the participation to discussion groups and the consultation of a bibliographic database pertinent to HBOT (WG A). In this frame, a study was performed. The aim of the study was : “Collecting, indexing and analysis of all relevant publications at the European level on Hyperbaric Oxygen Therapy and setting up a database”.
- a « Research Guidance Document » specifying the quality criteria desired for any new and ongoing research projects on HBOT, based on the analysis of existing research data and of the weight of the available scientific data (WG B).
- a « Research Priority Report », defining areas needing further clarification urgently, that will serve as a basis for directed clinical and experimental research (WG C). After having completed its task, this working group has launched 5 specific research teams devoted to one of the selected topics:
- Working group 1 : Sudden deafness
- Working group 2 : Femoral head necrosis
- Working group 3 : Oncology
- Working group 4 : Diabetic foot lesions
- Working group 5 : Technical aspects of HBOT
Later on, this last one was reshaped in an other form as Working group on “Safety aspects of HBOT”
Due to the administrative and financial difficulties of the COST program, only 2 meetings with a limited number of participants could be organised in 2002 and no meeting at all for the first semester of 2003. If the clinical studies already launched have moderately suffered from this fact, the other activities of the COST action B14 have been slowed down. In order to achieve the goals assigned to the action B14 in the MoU, prolongation requests have been issued and agreed.
A reflection about the future cooperation in the field of Hyperbaric oxygen Therapy once the COST action B14 finished, has been initiated by the Management Committee. Two main topics emerged: education and hyperbaric oxygen therapy in intensive care patient. In order to pursue the reflection, 2 new working groups has been designed , the first one “ Education” with a project of an European educational network in hyperbaric medicine, the second “ HBO and Intensive Care” with a research project on the specificities in physiologic and pathophysiologic responses of intensive care patient in HBO.
„ Participation and co-ordination
4.1 Management Committee
Chairperson : Pr. D. MATHIEU
Professor in Intensive Care Medicine - Université de Lille II
Service d’Urgences Respiratoires, de Réanimation
Médicale et de Médecine Hyperbare
Hôpital Calmette
CHRU de Lille
F.59037 Lille Cedex
Tel : +33-3-20.44.54.91
Fax : +33-3-20.44.50.94
E-mail :dmathieu@chru-lille.fr
Vice chairperson : Dr. P. GERMONPRE
Center for Hyperbaric Oxygen Therapy
Military Hospital Queen Astrid
Bruynstraat 200
B-1120 Brussels
Tel : +33-2-264.48.68
Fax : +33-2-264.48.61
E-mail : peter.germonpre@smd.be
Secretary : Pr. M. PASCU
DG Research / B5 - COST Secretariat
Rue de la Loi 200 ; Office: SDME 9/76
B-1049 Brussels
Tel: +32-2-299 15 56
Fax: +32-2-296 42 89
E-mail: mihail.pascu@cec.eu.int
LIST OF NOMINATED MEMBERS AND OBSERVERS
AUSTRIA
Institut für medizinische Physiologie
Medizinischen Fakultät
Unversitât Wien
Universitätsklinik für Anästhesie und Intensivmedizin
Ludwig Boltzmann-Institut für Anästhesie und Intensivmedizin
Wien
BELGIUM
Dr. Peter GERMONPRE
Center of Hyperbaric Oxygen Therapy
Military Hospital Queen Astrid
Brussels
Center for Hyperbaric Oxygen Therapy
Military Hospital Queen Astrid
Brussels
Diving and Hyperbaric Department
Larnaca General Hospital
Larnaca
CZECH REPUBLIC
Dr Jiri RUZICKA
Charles University
Medical Faculty of Plzen
Pilsen
DENMARK
H.S Rigshospitalet
Anætesi-og operationsklinikken
København
H:S Rigshospitalet
Anætesi-og operationsklinikken
København
FINLAND
Head of Intensive Care Unit for Adults
Dept of Anesthesia and Intensive Care
University Central Hospital
Turku
Pr. Juha NIINIKOSKI
Professor of Surgery and Chairman
Department of Surgery
University Central Hospital
Turku
FRANCE
Pr. Daniel MATHIEU
Hôpital Calmette - CHRU
Service d’Urgence Respiratoire, de Réanimation Médicale
et de Médecine Hyperbare
Lille
Hôpital Salvator - AP-HP
Service de réanimation de médecine hyperbare
Marseille
GERMANY
Aerztlicher Direktor des HBO-Zentrums
Rhein-Neckar
Diakonissenkrankenhaus Mannheim
Mannheim
Diakoniekrankenhaus
Klinik für Strahlentherapie
Radioonkologie und Nuklearmedizin
Rotenburg / Wümme
GREECE
Hyperbaric Department Director
“ST. PAUL’S” General Hospital
Thessaloniki
Naval Hospital of Athens
Dept. of Hyperbaric Oxygen
Athens
ISRAEL
Dr. Yehuda MELAMED
Elrom Hacarmel Ltd Hyperbaric Medical Center
Haifa
ITALY
Dr. Pasquale LONGOBARDI
Centro iperbarico SRL
Ravenna
Dr. Monica ROCCO
Policlinico Umberto I
Istituto di Anestesiologia e Rianimazione
Roma
POLAND
Institute of Maritime and Tropical Medicine
National Center of Hyperbaric Medicine
Gdynia
Dr. Jacek KOT
Institute of Maritime and Tropical Medicine
National Center of Hyperbaric Medicine
Gdynia
PORTUGAL
Hyperbaric Medical Centre
NAVY Hospital
Lisboa
Dr. Antonio Cesar GATA SIMAO
Hyperbaric Medical Centre
NAVY Hospital
Lisboa
SLOVENIA
Baromedical Centre
Ljubljana
SPAIN
Dr. Jordi DESOLA
CRIS – Unitat de Terapeutica Hiperbarica
Hospital Cruz Roja
Barcelona
Dr. Francisco RIOS
CIMA
Arturo Soria 82
Madrid
SWEDEN
Div. of Hyperbaric Medicine
Dept. of Anesthesiology and Intensive Care
Karolinska Hospital
Stockholm
Pr. Dr. Gosta GRANSTRÖM
Dept. of Otolaryngology
Sahlgrenska University Hospital
Göteborg
SWITZERLAND
Foundation for Hyperbaric Medicine
Kleinhüningerstrasse 177
Basel
Dr Daniel BLICKENSTORFER
Segantinistr. 71
Zürich
THE NETHERLANDS
Afdeling Radiotherapie, sectie Radiobiologie
Faculteit der Geneeskunde - Vrije Universiteit Medisch Centrum
Amsterdam
Dr. A.J. VAN DER KLEIJ
Academic Medical Center
Department of Surgery
Amsterdam
UNITED KINGDOM
Chairman of Drugs and Therapeutic Committee
Whipps Cross University Hospital
London
4.2 Participating Institutions
4.3 Meetings of the Management Committee
1) 1999, March 19th : Brussels, Belgium
2) 1999, September 25th : Düsseldorf, Germany
3) 1999, December 10th : Amsterdam, The Netherlands
4) 2000, March 24th-25th : Copenhagen, Denmark
5) 2000, September 30th : Ravenna, Italy
6) 2001, April 19th -21st : Gdynia, Poland
7) 2001, December 13th-15th : Ljubjana, Slovenia
8) 2002, April 18th -20th : Thessaloniki, Greece
9) 2002, October 19th : Prague, Czech Republic
10) 2003, September 20th : Barcelona, Spain
11) 2004, May 8th : Turku, Finland
12) 2004, December 2nd,4th : Lille, France
4.4 Meetings of the Working Groups
- Meetings of Working Group A : « Information Network »
1) 1999, March 19th : Brussels, Belgium
2) 1999, September 25th : Düsseldorf, Germany
3) 1999, December 10th : Amsterdam, The Netherlands
4) 2000, March 24th-25th : Copenhagen, Denmark
5) 2000, June 17th : Gdynia, Poland
6) 2000, September 28th : Ravenna, Italy
7) 2001, April 19th : Gdynia, Poland
8) 2001, December 13th : Ljubjana, Slovenia
9) 2002, April 18th : Thessaloniki, Greece
10) 2002, October 17th : Prague, Czech Republic
11) 2003, September 18th : Barcelona, Spain
12) 2004, May 6th : Turku, Finland
13) 2004, December 2nd : Lille, France
Final Report approved by Management Committee, the 2nd of December, 2004.
- Meetings of Working Group B : « Research Guidance Document »
1) 1999, March 19th : Brussels, Belgium
2) 1999, September 25th : Düsseldorf, Germany
3) 1999, December 10th : Amsterdam, The Netherlands
Final Report approved by Management Committee, the 11th of December, 1999.
- Meetings of Working Group C : « Research Priority Report »
1) 1999, March 19th : Brussels, Belgium
2) 1999, September 25th : Düsseldorf, Germany
3) 1999, December 10th : Amsterdam, The Netherlands
4) 2000, March 24-25th : Copenhagen, Denmark
Final Report approved by Management Committee, the 25th of March, 2000.
- Meetings of Working Group 1 : « Sudden Deafness »
1) 2000, March 25th : Copenhagen, Denmark
2) 2000, June 13th : Marseille, France
3) 2000, September 29th : Ravenna, Italy
4) 2001, April 20th : Gdynia, Poland
5) 2001, October 18th : Lisbon, Portugal
6) 2001, December 14th : Ljubjana, Slovenia
7) 2002, April 19th : Thessaloniki, Greece
8) 2003, September 19th : Barcelona, Spain
9) 2004, May 7th : Turku, Finland
10) 2004, December 1st : Lille, France
Final Report approved by Management Committee, the 2nd of December, 2004.
- Meetings of Working Group 2 : « Femoral Head Necrosis »
1) 2000, September 9 th : Vicenza, Italy
2) 2000, December 16 th : Vicenza, Italy
3) 2002, April 19th : Thessaloniki, Greece
4) 2002, October 17th-18th: Prague, Czech Republic
5) 2003, September 19th: Barcelona, Spain
6) 2003 December 6th : Brussels, Belgium
7) 2004, May 7th : Turku, Finland
8) 2004, December 1st : Lille, France
Final Report approved by Management Committee, the 2nd of December, 2004.
- Meetings of Working Group 3 : « Oncology »
1) 2000, March 25th : Copenhagen, Denmark
2) 2000, September 2nd : Hamburg, Germany
3) 2000, September 29th : Ravenna, Italy
4) 2000, November 24th-25th : Lisbon, Portugal
5) 2001, April 20th : Gdynia, Poland
6) 2001, December 14th : Ljubjana, Slovenia
7) 2002, April 19th : Thessaloniki, Greece
8) 2002, October 17th-18th : Prague, Czech Republic
9) 2003, September 18th-19th: Barcelona, Spain
10) 2004, May 6th-7th : Turku, Finland
11) 2004, December 1st : Lille, France
Final Report approved by Management Committee, the 2nd of December, 2004.
- Meetings of Working Group 4 : « Diabetic foot lesions »
1) 2000, March 25th : Copenhagen, Denmark
2) 2000, June 3rd : Brussels, Belgium
3) 2000, September 29th : Ravenna, Italy
4) 2000, December 16th : Brussels, Belgium
5) 2001, April 20th : Gdynia, Poland
6) 2001, December 14th : Ljubjana, Slovenia
7) 2002, April 19th : Thessaloniki, Greece
8) 2002, October 18th : Prague: Czech Republic
9) 2003, September 19th : Barcelona, Spain
10) 2004, May 7th : Turku, Finland
11) 2004, December 1st : Lille, France
Final Report approved by Management Committee, the 2nd of December, 2004.
- Meetings of Working Group : « Technical Aspects of HBOT »
1) 2000, March 25th : Copenhagen, Denmark
2) 2000, April 11th : Brussels, Belgium
3) 2000, June 30th-July 1st : Barcelona, Spain
4) 2000, September 29th : Ravenna, Italy
5) 2000, November 17th-18th : Brussels, Belgium
6) 2001, February 2nd-3rd : Paris, France
7) 2001, April 19th-20th : Gdynia, Poland
Final Report approved by Management Committee, the 20th of April, 2001.
- Meetings of Working Group : « Safety aspects of HBOT »
1) 2001, April 20th : Gdynia, Poland
2) 2001, September 12th : Hamburg, Germany
3) 2001, December 14th : Ljubljana, Slovenia
4) 2002, March 22nd-23rd : Paris, France
5) 2001, April 19th : Thessaloniki, Greece
6) 2002, September 4th : Brugge, Belgium
7) 2002, October 17th-18th : Prague, Czech Republic
8) 2003, August 28th : Copenhagen, Denmark
9) 2003, September 18th-19th: Barcelona, Spain
10) 2003, December 5th-6th : Brussels, Belgium
11) 2004, May 6th-7th : Turku, Finland
12) 2004, December 1st : Lille, France
Final Report approved by Management Committee, the 2nd of December, 2004.
- Meetings of the Working Group : “ Education and training in Hyberbaric Medicine ”
1) 2004, May 5th : Turku, Finland
2) 2004, September 15th : Ajaccio, France
3) 2004, December 1st : Lille, France
Final Report approved by Management Committee, the 2nd of December, 2004.
- Meetings of the Working Group : “ Intensive Care in HBO ”
1) 2004, May 6th : Turku, Finland
2) 2004, September 16th : Ajaccio, France
3) 2004, December 2nd : Lille, France
Final Report approved by Management Committee, the 2nd of December, 2004.
4.5 Short-term scientific missions
Although a STSM was obtained, due to an ill-understanding, the COST B14 members did not use it in the due time. It was decided to introduce a new STSM request once applications would have been received. It was also decided to advertise about this possibility of mobility, especially on the website.
During the MC meeting of Deptember, 2nd 2004, STSM applications were approved in the frame of the WG “Intensive care in HBO” and Dr Ratzenhofer-Komeda from Graz, Austria spent 3 weeks in the Hyperbaric center of Lille, France to perform a study on the hemodynamic changes induced by HBO in patients under controlled ventilation. This study has been presented in part during the 2005 EUBS scientific meeting and is still on-going.
… Results
The COST Action B14 has been implemented and conducted according to the planning included in the MoU.
In the frame of the WG A, the implementation of an information network has been done through the building-up of a web site : www.oxynet.org. Actually, the Information Technology Framework had been fully designed, and set up as a dual Communication and Information system.
The OXYNET Website has been developed with the following functionalities :
- A comprehensive database of all HBO Centres in Europe, with the most relevant contact and functional information (accessible to the general medical public)
- A COST B14 information section, to be considered as an on-line information and communication tool in order to facilitate the work of the different COST B14 Working Groups. This section also contains (in a pass-word protected area) online discussion groups for each WG, as well as the Meeting Reports, relevant non-peer reviewed bibliographic information and other « sensitive » information.
- A « general medical public » discussion group area, with on-line monitoring of the discussions by members of WG A
- A « links section » providing easy access to other HBO-related organisations and institutions.
The design, modularity and content of the OXYNET HBO Information Dissemination Network makes it an ideal tool for the facilitation of the further course of COST Action B14, as well as a comprehensive information database for the HBO Medical Community.
The Database and Internet Website Hosting were performed at the National Hyperbaric Centre at the Institute for Maritime and Tropical Medicine in Gdynia, Poland. A permanent internet access has been provided by the Informatics Department of this Institute, on a dedicated server with the necessary redundancy and maintenance. Remote administration was installed, with secure login and FTP-access, in order to allow changes to the database to be made from a remote location by all authorised members of WGA. This has permitted the continuous update of the server and gradual development of the system.
As planning in the MoU, the working group A has continued to update and to monitor this information network. The website was further completed with information as it became available. A new design and functional layout was proposed in order to facilitate information retrieval and site browsing.
An evaluation of the oxynet web site was performed. The site was well and regularly visited ( between 10 000 and 16 000 visits per month). Users came for a half from Europe and for the other half from the rest of the world. The statistics of website usage showed the most accessed information was regarding general information about HBO, list of registered centres, and the COST B14 Action. ( See annex 1 ).
The working group B was devoted to produce guidelines concerning research studies in the HBOT field. It completed its task for the end of 1999 in producing a document « Research quality Guidelines ». This document stresses the points to be taken into account in research due to the specificity of HBOT.
The working group C has the difficult task of making an inventory of the on-going research protocols in the European HBOT Community and to set-up a priority list for those where a European support was most indicated. Four topics were thought to fulfil both the need of an European co-operative study design and the requirement edited by the working group B.
Specific working groups were established (called Research team in the MoU) and have been working in order to design or adapt research protocols suitable for European co-operative studies. Six protocols are actually implemented and in the patient inclusion phase :
l Hyperbaric Oxygen in the acute treatment of sudden idiopathic sensorineural hearing loss (study co-ordinator : A. Barthelemy, Marseille, France). Study has started in September 2002; 7 centers are participating and 56 patients have been included. To speed on the inclusion process, a randomisation procedure has been implemented through the Internet. The WG agreed to have meetings during the EUBS annual congress in order to continue to monitor the on-going study even after the end of the B14 action.
l Re-irradiation of recurrent squamous cell carcinoma of the head and neck after HBOT sensitisation (study co-ordinator : K. A. Hartmann, Düsseldorf, Germany). Study has started in January 2002.
l Role of hyperbaric oxygen in enhancing radio sensitivity of glioblastoma multiforme : a clinical study (study co-ordinator : F. Fehlauer, Hamburg, Germany). Study has started in January 2002
l Osteo integration in irradiated patients. Adjunctive HBOT to prevent implant failures (study co-ordinator : C. Granstrom, Stockholm, Sweden).Study has started in October 2001.
l Hyperbaric Oxygen in the treatment of foot lesions in diabetic patients (study co-ordinator : D. Mathieu, Lille, France). Study has started in May 2002. 10 centres are participating and 56 patients have been included. Two centers will start to include patients in 2006. Two more centres are still waiting to receive agreement from their Ethic Committee .
l Hyperbaric Oxygen in the treatment of patients with mild to moderate femoral head necrosis (study co-ordinator : L. Ditri, Vincenza, Italy). Protocol has been finalised and patient inclusion has started in 2005.
One other study is in its finalisation phase.
l The role of HBOT in the treatment of late irradiation sequelae in the Pelvic region (study co-ordinator : A. Van der Kleij, Amsterdam, The Netherlands). Protocol will be finalised in 2005 and call for participation launched.
All these protocols are accessible on the Oxynet web site and a discussion forum is opened for each topic.
Even if not research-oriented, a working group, focused on technical and safety aspects of HBOT was also established in order to guarantee that the eventual increase in HBOT use in clinical practice, would not induce an increase in the occurrence of adverse events. The Management Committee decided during its 4th meeting (Copenhagen, February 2000) that the first objective of this working group should be the production of a harmonised European Standard for hyperbaric chambers, and a second, the elaboration of safety guidelines for Hyperbaric Medicine practice.
A risk analysis was elaborated following the EN 1441 document to identify critical areas. In parallel, due to action of participants at their national level, a request, issued by the German Institute for Normalisation (DIN), was introduced and accepted by the CEN which established a specific task force (CEN BT/TF 127) on this topic. Many of the COST participants have been invited to participate in this task force and COST Action B14 has been officially accepted as an external liaison to the BT/TF 127. Documents produced by the working group T were included in the working documentation of this BT/TF. Since the first objective of the working group « T » has been achieved, this working group has been reshaped to undertake its second objective as working group « Safety aspects of HBOT ».
The Working Group Safety (WG-S) was designed in order to summarize expertise of hyperbaric oxygen practitioners in the form of a document “ An European Code of Good Practice in Hyperbaric Oxygen Therapy”. This document has been finalized and approved by the MC during its Turku meeting ( May 2004). Dissemination of this document has included publication on the Oxynet web site for free down-loading and publication in the European Journal of Underwater and Hyperbaric Medicine. The COST program has supported the dissemination in ordering 1100 copies of that journal issue which will be sent to each hyperbaric centre in Europe and to selected opinion leaders in that field.
Most participants from WG Technical Aspects (WG-T) joined the WG-S. This document uses the r