FIRST EUROPEAN CONSENSUS CONFERENCE ON HYPERBARIC MEDICINE

LILLE , 19 - 21 September 1994

RECOMMENDATIONS OF THE JURY*

The scope of this first European Consensus Conference was to establish an agreement on the situation of Hyperbaric Medicine in Europe in 1994 with regard to the different aspects that characterize a medical discipline: field of application, operational rules and procedures, training of dedicated personnel, effectiveness evaluation, research.

Starting from these points the Jury, with the support of the Conference experts and rapporteurs, was called to formulate recommendations that could answer to the 6 following questions, after each one of them had been discussed and debated during monothematic workshops:

QUESTION 1 :

Which Treatment for Decompression Illness?

QUESTION 2 :

Which Acute Indications for Hyperbaric Oxygen Therapy?

QUESTION 3 :

Which Chronic Indications need Hyperbaric Therapy as an adjunctive treatment?

QUESTION 4 :

Which Safety Regulations for the design and use of medical hyperbaric chambers and of medical equipment for hyperbaric use?

QUESTION 5 :

Which initial Training and which Continuing Education for personnel employed in Clinical Hyperbaric Medicine?

QUESTION 6 :

Which Research to expect and plan for the next five year period?


Members of the Jury : E.M. Camporesi, New York (USA), A. Gasparetto, Rome (Italy), M. Goulon, Paris (France), L.J. Greenbaum, Bethesda (USA), E.P. Kindwall, Milwaukee (USA), M.Lamy, Liege (Belgium), D. Linnarsson, Stockholm (Sweden), J.M. Mantz, Starsbourg (France), C. Perret, Lausanne (Switzerland), P. Pietropaoli, Ancona (Italy), H. Takahashi, Nagoya (Japan), C. Voisin, Lille (France).

INTRODUCTION

The use of hyperbaric chambers in intensive care started in Europe more than 30 years ago; the present experience is sufficient to identify those clinical conditions where hyperbaric oxygen (HBO) has a therapeutic interest. Therefore the first scope of the Conference is to confront the obtained clinical results in order to search a consensus in the definition of recognized indications for HBO, according to three levels of priority:

a) Situations where the transport to a hyperbaric facility is strongly recommended because it is recognized that HBO positively affects the prognosis for survival. This implies that the patient is transferred to the nearest hyperbaric facility as soon as possible (type 1 recommendation).

b) Situations where the transport to a hyperbaric facility is recommended because it is recognized that HBO constitutes an important part of the treatment of that given condition, which, even if it may not influence the prognosis for patient's survival, it is nevertheless important for the prevention of serious disorders. This implies that the transfer to a hyperbaric facility is made, unless this represents a danger to the patient's life (type 2 recommendation).

c) Situations where the transfer to a hyperbaric facility is optional, because HBO is regarded as a additional treatment modality which can improve clinical results (type 3 recommendation)

Establishing a similar list is not an easy task, as in almost the totality of cases, the choice of an indication for treatment is based on clinical experience and not on controlled studies. Is it necessary, in similar conditions, that the validity of a given indication is again put under discussion and that the results of controlled prospective studies are awaited before defining lists of indications for Hyperbaric Oxygen therapy? This Jury does not think that this is appropriate. Clinical experience has an unquestionable value when it is the result of multiple agreeing observations, collected during many years and independently confirmed by different groups. In other words, it seems justified that indications for which there is unanimous consensus of the leading experts are accepted without further evidence.

A criticism to a similar attitude, which can lead to accept a treatment without any formal evidence of its efficacy, is that it can expose the patient to unknown potential damage. But we can answer that the choice of any treatment modality, be it medical or surgical, is always based on a careful evaluation of its risk / benefit ratio as compared to the patient's specific conditions . There are circumstances where clinical experience shows that the benefits of treatment are of such magnitude that the potential side-effects can be considered negligible. Serious carbon monoxide intoxication, for instance, is a condition where it would seem unreasonable to withdraw HBO because of the potential pulmonary oxygen toxicity effects. In situations such as the latter, the choice is simple; but it may be more complicated when the expected advantage is not as evident. In these situations the issue is the objective evaluation of the real interest and usefulness of the treatment modality.

The Jury has attempted to identify those clinical situations for which the efficacy of Hyperbaric Oxygen Therapy is unanimously recognized and where the evidence of beneficial effects of the treatment is such that the treatment should not be ethically denied. In other situations, where sufficient evidence in favour of HBO is not available, it is necessary to start evaluation procedures based on multicentre studies and on clearly defined protocol, as approved by a suitable ethical committee. Only after the completion of such studies will it be possible to accept a new indication.

Professor Claude PERRET - President of the Conference Jury

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QUESTION 1: WHICH TREATMENT FOR DIVING DECOMPRESSION ACCIDENTS ?

The primary cause of DCI is the separation of gas in the body tissues (bubbles).

Adjunctive pharmacological treatment is controversial but :

The continuation of a combined Hyperbaric Oxygen Therapy and rehabilitation treatment is recommended until clinical stabilisation or no further improvement is achieved (Type 2 recommendation)

Comments:

The minimal consensus obtained reflects the heterogeneous nature of the different conditions grouped under the definition "Decompression Illness", even if they share the same pathophysiological basis.
It must be remembered that the majority of the scientific papers on the subject refers to military or commercial diving. Considering the treatment results of these accidents, the role of pressure and the importance of the time factor in limiting the delay to recompression are unquestionable and consequently justify the need for hyperbaric chambers on the very site where commercial or military diving is performed.
The recent significant development of recreational diving, notwithstanding the stringent safety rules and procedures, is similarly accompanied by the occurrence of decompression accidents, based on the same pathophysiological mechanisms, but the situation is entirely different with regard to the start of therapeutic recompression procedures, as the interval to recompression is consistently longer, with the consequence that the efficacy of recompression may be compromised and impaired.
As a further consequence the therapeutic procedures are applied at different stages of the same illness, characterized by a multi-factorial evolution.
Thus, a reliable comparative analysis of the therapeutic results become delicate and risky, as it deals with different procedures applied to heterogeneous conditions. Answering these pending questions will only be possible after further studies conducted with adequately modified approaches

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QUESTION 2 : WHICH ACUTE INDICATIONS FOR HYPERBARIC OXYGEN THERAPY ?

1 - General:


II - Carbon Monoxide (CO) Intoxication

III - Gas Embolism

IV - Anaerobic or mixed bacterial Necrotizing Soft Tissue Infections

V - Acute Soft Tissue Ischemia

VI - Post-anoxic encephalopathy

VII - Burns

VIII - Sudden Deafness

IX - Ophthalmological Disorders

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QUESTION 3 : WHICH CHRONIC INDICATIONS NEED HYPERBARIC OXYGEN AS AN ADJUNCTIVE TREATMENT ?

I - Ischemic lesions (ulcers or gangene) without surgically treatable arterial lesions or after vascular surgery: II - Radionecrotic lesions:
III
- Osteomvelitis

IV - Other indications

Comments:

Only the indications generally accepted by the leading representatives of the discipline have been discussed.

Other Consensus Conferences, dedicated to the evaluation of certain particular aspects of the treatment of a disease for which HBO is aiready used or to new indications, seem aiready necessary. In fact the present recommendations should not prejudice the possible extension of the indications for Hyperbaric Oxygen Therapy. For example, chronic ophtalmological disorders, foeto-placentar insufficiencies, certain mycotic and parasital infections, peripheral arteriopathies, certain dermatological disorders, spinal and cerebral contusions are part of the HBO indications for which the evaluation is being currently conducted.

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QUESTION 4 : WHICH SAFETY REGULATIONS FOR THE DESIGN AND USE OF MEDICAL HYPERBARIC CHAMBERS AND OF MEDICAL EQUIPMENT FOR HYPERBARIC USE?


I - Minimal Prerequisites for the design of medical hyperbaric chambers and for medical equipment aimed at the emergency or intensive treatment of a patient under hyperbaric conditions :
II - Minimal Prerequisites for the design of medical hyperbaric chambers and for medical equipment for the treatment of chronic patients under hyperbaric conditions : III - Use of Oxygen-pressurized hyperbaric chambers IV - Safety Recommendations to be foreseen at European Union level V - Safety Regulations must be respected upon designing and using hyperbaric chambers and all medical instrumentation used in hyperbaric chambers :

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QUESTION 5 : WHICH INITIAL TRAINING AND WHICH CONTINUING EDUCATION FOR PERSONNEL EMPLOYED IN CLINICAL HYPERBARIC MEDICINE?

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QUESTION 6 : WHICH RESEARCH TO EXPECT AND PLAN FOR THE NEXT FIVE YEAR PERIOD ?

Comments:

The implementation of these recommendations suggest the need to create a European Ethical and Research Commission as well as of a Coordination and Information Structure with the following primary goals:

  1. establishment of a directory of centers and teams involved in Hyperbaric Medicine Research
  2. establishment of a network of consultants (epidemiologists, methodologists, engineers, etc..)
  3. organisation of seminars and workshops dedicated to clinical research training
  4. coordination of Reference Centers, after approval of the same by the European Ethical and Research commission (EERC)
  5. monitoring and assuring the achievement of the planned goals, as defined by the EERC

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