PROJECT REVIEW

 

COST Action B 14

 

HYPERBARIC OXYGEN THERAPY

 

 

Chairperson : Professor Daniel MATHIEU

 

 

Objectives

 

     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.

 

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 J. LECLERC

F-59307 Lille Cedex

 

Technical description and implementation

 

     The COST Action B14 "Hyperbaric Oxygen Therapy" MoU has been signed by 19 countries (A, B ,CH, CY, CZ, D, DK, E, F, FIN, GR, I, IL, NL, P, PL, S, SI, UK). It started on the 9th of December 1998 and is planned to end the 8th of March 2005.

     The action 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:

     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. 

 

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.

 

     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 and have been working in order to design or adapt research protocols suitable for European co-operative studies. Five protocols are actually implemented and in the patient inclusion phase :

 

• 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; 4 centers are participating and 34 patients have been included. One centre will shortly join the study. To speed on the inclusion process, a randomisation procedure will be implemented through the Internet.
• 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.
• Role of hyperbaric oxygen in enhancing radio sensitivity on glioblastoma multiforme : a clinical study (study co-ordinator : F. Fehlauer, Hamburg, Germany). Study has started in January 2002
• Osteo integration in irradiated patients. Adjunctive HBOT to prevent implant failures (study co-ordinator : C. Granstrom, Stockholm, Sweden).Study has started in October 2001.
• Hyperbaric Oxygen in the treatment of foot lesions in diabetic patients (study co-ordinator : D. Mathieu, Lille, France). Study has started in May 2002. 8 centres are participating and 29 patients have been included. Two more centres are actually waiting to receive agreement from their Ethic Committee  to join.

 

      Two others studies are in their finalisation phase.

 

 

     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 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 "Rules of Good Clinical Practice in the Hyperbaric Oxygen Therapy". Most participants from WG Technical Aspects (WG-T) joined the WG-S. This document uses the risk analysis prepared by WG-T and is linked to the project of the European norm concerning construction of multiplace pressure chambers which is being prepared by CEN/BT/TF127. The document is intended to be a reference document for European countries wanting to issue or update their own Guidelines, Regulations, Standards, or Codes of Practice in hyperbaric medicine. In 2003, the chapter concerning safety management and risk analysis was updated to reflect new norm EN ISO 14971 "Medical devices – Application of risk management to medical devices".

 

     The chairman of the WG-S is officially appointed as an external liaison officer to the CEN/BT/TF127 to ensure that results of both groups will be complementary to each other and regularly participate in TF127 meetings. The close cooperation with CEN/BT/TF127 led to the implementation of results of WGT (Final Report).

 

Dissemination of results

 

     Dissemination of results have been made by publications (189 articles), reports elaborated in the Working Groups, organisation of meetings and conferences (Consensus Conference on HBOT in the treatment of diabetic foot lesions, December 4th-5th, 1998, London, United Kingdom; Consensus Conference on HBOT and radiation-induced lesions in normal tissues, October 19th-20th, 2001, Lisbon, Portugal; next planned : Consensus Conference on Hyperbaric Oxygen Therapy indication and practice, Decemb

er 3th-4th, Lille France) and information in the web site (www.oxynet.org).

     A close scientific cooperation have been established with the European scientific society (European Underwater and BaroMedical Society) and the professional organisation (European Committee for Hyperbaric Medicine).

     A direct transfer of results acquired by the action has been the elaboration of an harmonised European norm on hyperbaric therapeutic chamber (Comité Européen de Normalisation BT/TF 127).