7th EUROPEAN CONSENSUS CONFERENCE
ON HYPERBARIC MEDICINELILLE, DECEMBER 3rd – 4th 2004

Correspondance to be addressed to:

Pr D. Mathieu
Service d’Urgence Respiratoirede Réanimation Médicale et de Médecine Hyperbare
Hôpital Calmette
CHRU LILLE
59037 LILLE Cedex
FRANCE-1-

Honorary Président : M. GOULON

Scientific Committee : D. BAKKER, A.. MARRONI, D. MATHIEU

Consensus Jury
F. WATTEL, ( France), Président
N. BITTERMAN (Israel, EUBS)

L. DITRI (Italy)

M. HAMILTON-FARELL (United Kingdom)

A. KEMMER (Germany)

F. LIND (Sweden)

JM. MÉLIET (France)

T. MESSIMERIS (Greece)

J. NIINIKOSKI (Finland)

F. ROQUE (Portugal)

Z. SICKO (Poland)

A. VAN DER KLEIJ (The Netherlands)

QUESTIONSn

What are the levels of evidence presently supporting the accepted indications of HBO2?

oWhat are presently the recommendations concerning the preventive measures and thetreatment of the accidents induced by hyperbaric pressure?

p

What are presently the recommendations concerning the organization and the practice in atherapeutic hyperbaric centre?

qWhat are presently the requirements concerning the design and the safety of therapeutic
hyperbaric chambers and the related medical devices?

r

What are presently the requirements concerning the management of patients treated by
HBO2?

s

What are presently the requirements concerning the initial and continuous education oftherapeutic hyperbaric centre staff?

tWhat may be presently recommended concerning the research in hyperbaric medicine for the
next future?

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PRESIDENTIAL ADDRESS :The first ECHM European Consensus Conference for Hyperbaric Medicine (HBO) was heldin Lille, 19th-21st of September, 1994. It was attended by more than 300 participants andafter 2 days of intense debates, recommendations were issued concerning the clinicalindications accepted for HBO, the organisational aspects of HBO centres, the education andtraining of HBO personnel, the clinical and fundamental research to be done in that field.
Ten years elapsed since this 1st Conference and a tremendous amount of works has been
done not only through the organisation of Consensus Conferences and Workshops but also
by launching actions in the field of cooperation in research, education, safety at theEuropean level.
Time has come for a new synthesis of all these actions and studies in order to update the
ECHM recommendations and determine the new axes of progress for the future.
Professor D. J. BAKKER
President of the European Committee for Hyperbaric Medicine

RECOMMENDATIONS OF THE JURY :Introduction

The aim of the Consensus Conferences organized by the European Committee forHyperbaric Medicine (ECHM) is to reach an agreement on how Hyperbaric Medicine should
be delivered with regard to its different aspects: indications, organisational aspects,
education and training of personnel, operational rules and procedures, evaluation and quality
assurance, research.

The first ECHM Consensus Conference was held in Lille in 1994 and, after 2 days ofintense debates, recommendations were issued. At that time, it was found that not many ofthese recommendations were supported by a high level of evidence according to themethodology of Evidence-Based Medicine, but as these recommendations wereconsensually agreed by a large number of experts, they were regarded as a good starting
point for further research and experience.

Ten years have elapsed since this first Conference and a tremendous amount of work
has been done in Europe and elsewhere. The time has come to review these 1994
recommendations and to elaborate a new synthesis.

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The method of Evidence-Based Medicine (EBM) has gained a large agreement and ispresently an integral part of modern medical practice. It is typically based on 3 axes : (1) thelevel of evidence (i.e. quality of available data), (2) interpretation of the evidence (i.e. what
the data suggest and how concordant these data are regarding a particular problem), and (3)the type or strength of the recommended practice (i.e. the extent to which a physician is able
to recommend a particular intervention on the basis of the first two considerations). Thismethod may be used either by an individual physician or by a group of experts who could be
expected to arrive at the same conclusion.

Unfortunately, this method is only applicable when high quality randomized controlled
clinical studies exist. When there is a lack of data, the search for a consensus of experts isthe method the most widely adopted. This method is regarded as the best surrogate to EBM
method to evaluate interventions under the following circumstances. (1) Where a particularintervention, unsupported by a high level of evidence, has become universally accepted tosuch an extent that it would be considered a violation of accepted standards of care to denya patient the benefit of the therapy for the purpose of a study. (2) Where the disease orcondition of interest is so complex or where there are so many variables that it would be
impossible to design a study sufficiently powerful to evaluate any single intervention. (3)Where the application of the therapy is so logical that it would be grossly inappropriate toconsider omitting it to establish proof of efficacy. (4) Where no current higher level ofevidence exists, but experts are able to report, not only from their own experiences but also
by producing comprehensive literature reviews from which consensus can provisionally bereached, pending the outcome of future studies.

Even if an enormous effort has been made by the hyperbaric medicine community inorder to acheive high quality clinical studies, we are forced to recognize that in our field,
many questions remain without sufficient evidence to give a definite answer. During its
debates, the jury was faced with a number of conditions where the evidence was evaluatedas insufficient to put them on the list of accepted indications for Hyperbaric Oxygen Therapy(HBO2). With other conditions, recent data did not convince the Jury of the efficacy of HBO2.
In these cases, the Jury adopted a “conservative” attitude while awaiting future studies.
However, far from discouraging us, this must be a strong stimulant to increase our research
effort and improve the quality of our practice.

As for the recommendations of the first ECHM Consensus Conference, those issued
by the Jury of this 7th ECHM Consensus Conference have to be looked at a new step forward
and a new starting point for the next 10 years.

Professor Francis WATTEL
President of the Jury
7th ECHM Consensus Conference-4-Methodology of 7th ECHM Consensus Conference

Consensus Conferences aim to create an objective and complete review of current
literature and knowledge on a particular topic or field. This method has the advantage of
involving a diverse group of experts, thus increasing objectivity. Participants in Consensus
Conferences are selected from a broad range of relevant backgrounds to provide
consideration of all aspects of the chosen topic and maximum objectivity. The opportunity tomeet with other experts in the same field and share comments and information is also avaluable aspect of Consensus meetings.
In a Consensus Conference, experts present their review of the literature relating to a
specific topic in front of a jury and an audience. Thereafter, the jury gathers in a secluded
place to discuss the presentations, and presents its finding in a Consensus Statement that
includes recommendations for clinical practice based on the evidence that was presented.
These recommendations are published in the medical literature.
The application of Evidence-Based Medicine methodology to the consensus
conference process helps the jury members to reach a consensus and strengthens therecommendation made. Thus, it is proposed each jury member assesses the literature andthe evidence presented by the experts, and grades those according to their quality.
We propose each jury member uses the same grading scale, which has been
extensively validated.
Basic studies (tissular, cellular or subcellular level)
1. Strong evidence of beneficial action
2. Evidence of beneficial action
3. Weak evidence of beneficial action
4. No evidence of beneficial action, or methodological or interpretation bias precluding
any conclusion.
Animal studies with control group
1. Strong evidence of beneficial action
2. Evidence of beneficial action
3. Weak evidence of beneficial action
4. No evidence of beneficial action, or methodological or interpretation bias precluding
any conclusion

Human studies
1. Strong evidence of beneficial action based on at least two concordant, large,
double-blind, controlled randomised studies with no or only weak methodologicalbias.
2. Evidence of beneficial action based on double-blind controlled, randomised studies
but with methodological bias, or concerning only small samples, or only a single
study.
3. Weak evidence of beneficial action based only on expert consensus or
uncontrolled studies (historic control group, cohort study,...)
4. No evidence of beneficial action (case report only), or methodological orinterpretation bias precluding any conclusion.

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ECHM Recommendations
The Jury will issue its recommendations using a 3 grade scale according to thestrength each recommendation has been evaluated.
Type 1 : Strongly Recommended. The Jury considers the implementation of therecommendation of critical importance for final outcome of thepatient/quality of practice/future specific knowledge.
Type 2 : Recommended. The Jury considers the implementation of therecommendation as positively affecting final outcome of the patient/qualityof practice/future specific knowledge.
Type 3 : Optional. The Jury considers the implementation of the recommendation
as an option.
The Jury will also report the level of evidence which supports, in its view, therecommendation.
Level A : Recommendation supported by level 1 evidence.
Level B : Recommendation supported by level 2 evidence
Level C : Recommendation supported only by level 3 evidence.
In using such a methodology, we expect every physician reading the jury conclusions
will be immediately able to assess the strength of evidence supporting each statement andhow it has to be applied in clinical practice.

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QUESTION 1
WHAT ARE THE LEVELS OF EVIDENCE PRESENTLY SUPPORTING THE ACCEPTED INDICATIONS OF
HBO2?

* Recommendations for HBO2 indication have been issued on the understanding that no
personal skill nor technical limitation interferes with the decision to treat with HBO2.
* Hyperbaric Oxygen Therapy implies the administration of oxygen under pressures not lower
than 2 ATA and for durations not less than 60 minutes.
* Hyperbaric Oxygen Therapy must be seen as part of a therapeutic continuum, without any
interruption of the chain of treatment. It cannot be considered as an isolated treatment
modality.
* Technical competence and personal skills at the hyperbaric facility must be adequate andsuch that no potential accident, adverse event or problem occuring during the patient’s stayin the facility will be likely to worsen the outcome of the patient.
* Hyperbaric facilities accepting emergency indications in patients potentially requiring
Intensive Care should be hospital based and located in or immediately near-by a hospital
Intensive or Emergency Care Department.

I - Carbon Monoxide (CO) Intoxication* Carbon monoxide intoxications must be treated with normobaric oxygen as a first aid
treatment (Type 1 recommendation, level C)* Hyperbaric Oxygen Therapy is recommended in patients with diagnosed carbon monoxide
poisoning when at high risk of immediate or long term complications. (Type 1
recommendation)
High risk includes :- Unconsciousness at or before admission (level B)- Clinical neurological, cardiac, respiratory or psychological symptoms or signs(level B)- Pregnant women (level C)* Treatment delayed beyond 24 hours after the last exposure to poison is not recommended
if the patient has become symptom-free. (Type 3 recommendation, level C)* In carbon monoxide poisoned patients not at high risk, there is a choice between
normobaric oxygen therapy for 12 hours and HBO2. Until the results of further randomized
studies are available, HBO2 remains optional in these patients (Type 3 recommendation,level C).

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II - Decompression Accident (see answer question 2)

III - Gas Embolism* Hyperbaric Oxygen Therapy is strongly recommended, whatever the presentation of air
embolism. (Type 1 recommendation, level C)

IV - Anaerobic or mixed anaero-aerobic bacterial infections
1- Necrotizing soft tissue infections :Hyperbaric Oxygen Therapy is strongly recommended in the treatment of anaerobic
or mixed bacterial necrotizing soft tissue infections (myonecrosis, necrotizing fasciitis, etc…).
HBO2 therapy should be integrated in a treatment protocol comprising adequate surgical andantibiotic therapy (Type 1 recommendation, level C).
The sequential order for HBO2, antibiotics and surgery is a function of the conditionof the patient, the surgical possibilities and hyperbaric oxygen availability. (Type 1
recommendation, level C)
2- Selected cases of organ abscess including intracranial, pleuro-pulmonary,and liver abscess :Selection criteria may include failure of an appropriate conventional initial therapy, highsurgical risk, compromised general condition of the patient. (Type 1 recommendation, levelC)

V - Acute Soft Tissue Ischemia* HBO2 is recommended in post traumatic crush injury following open fracture Gustilo type III
B and C (Type 1 recommendation, level B)* HBO2 is optional in reperfusion syndromes following invasive vascular procedure (Type 3
recommendation, level C)* HBO2 is recommended in compromised skin grafts and myo-cutaneous flaps (Type 2
recommendation, level C)* HBO2 is optional in the re-implantation of traumatically amputated limb segment (Type 3
recommendation, level C)* In every case, the measurement of transcutaneous oxygen pressure is recommended as
an index for the definition of the indication and of the evolution of treatment (Type 1
recommendation, level B)-8-VI - Radio-induced Lesions
The jury felt the data published since the 5th ECHM Consensus Conference in Lisbon,
focused on the role of HBO2 in the treatement of radio-induced lesions in normal tissues,
have not changed the overall evaluation made by the Jury of that Conference. Therefore, it
endorses the recommendations issued at that time.
HBO2 is indicated in :* Radionecrosis of the mandible* Radio-induced cystitis resistant to conservative treatment* Tooth extraction in irradiated tissues (preventive action)(Type 1 recommendation, level B)* Radionecrosis of other bones* Radio-induced proctitis/enteritis* Radio-induced lesions of soft-tissues* Surgery and implants in heavily irradiated tissues (preventive action)(Type 2 recommendation, level C)* Laryngeal radionecrosis* Central nervous system radionecrosis(Type 3 recommendation, level C)

VII – Delayed wound healing
1- Ischemic lesions (ulcer or gangrene) without the possibility
revascularization, or lesions persisting after optimal revascularization:of* In the diabetic patient, the use of HBO2 is recommended in the presence of a Chronic
Critical Ischemia as defined by the European Consensus Conference on Critical Ischemia(note 1), if perilesional transcutaneous oxygen pressures measured under hyperbaric
conditions (2.5 ATA, 100% Oxygen) are higher than 100 mmHg (Type 2 recommendation,level B)
* In the arteriosclerotic patient, the use of HBO2 is recommended in case of a Chronic Critical
Ischemia (note 1), if perilesional transcutaneous oxygen pressures measured under
hyperbaric conditions (2.5 ATA, 100% Oxygen) are higher than 50 mmHg (Type 2
recommendation, level C)
note 1 : Chronic Critical Ischemia:
periodical pain, persistent at rest, needing regular analgesic treatment for more than two
weeks, or ulceration or gangrene of foot or toes with ankle systolic pressure <50 mmHg in
the non-diabetic or toe systolic pressure <30 mmHg in the diabetic ( Second European
Consensus on Critical Ischemia: Circulation 1991, 84, IV, 1-26)

2- Selected non-healing wounds secondary to inflammatory processes:* HBO2 may be used in selected non-healing wounds secondary to inflammatory processes,
but only in association with optimized conventional treatment.
(Type 3 recommendation, level C).

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VIII - Osteomyelitis* HBO2 is recommended in chronic refractory osteomyelitis defined as osteomyelitic lesions
persisting for more than six weeks after adequate antibiotic treatment and at least one
operative procedure (Type 2 recommendation, level C).
* In cranial (excluding mandible) and sternal osteomyelitis, HBO2 should be started
simultaneously with antibiotics and surgical treatment (Type 2 recommendation, level C).

IX - Post-anoxic encephalopathy* HBO2 is optional for the treatment of cerebral anoxia (Type 3 recommendation, level C)

X - Burns* HBO2 is optional when burns exceed 20% of body surface and are of second degree ormore (Type 3 recommendation, level C)* If burned areas (excepted for head, hands, perineum) are less than 20% of body surface,
HBO2 is not recommended (Type 1 recommendation, Level C)

XI - Sudden Deafness* Multiple treatment modalities have been proposed for sudden deafness with no high level
evidence for any of those. HBO2 remains recommended in sudden deafness (Type 2
recommendation, level C) until the results of the on-going European randomized controlled
study are published.

XII - Ophthalmological Disorders* HBO2 is optional in acute ophthalmological ischemia (type 3 recommendation, level C)
XIII – Neuroblastoma Stage IV
Although there has been no randomized controlled study published, there is convincing
accumulation of data showing a beneficial action of HBO2 combined with conventional
therapy. HBO2 should be considered in combination with other accepted treatment forpatients with neuroblastoma stage IV (Type 2 recommendation, level C)
XIV – Pneumatosis Cystoides Intestinalis.
HBO2 treatment may be used in selected cases of pneumatosis cystoides intestinalis as analternative to surgery when there is no signs of acute complications, such as perforation,
peritonitis and bowel necrosis. (Type 3 recommendation, level C)- 10 -

XV - Other indications* Many other indications accepted by other scientific societies or leading representatives
have been reviewed but are not currently recognized indications for Hyperbaric Therapy(Table 1). Various research protocols are currently in progress; and results need to be
awaited before issuing definite recommendations.

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Table 1 : List of potential and proposed indications for Hyperbaric Oxygen Therapy.
After having listened the experts and with the assistance of literature reviewers, the Jury has graded the existing
evidence using the scale used in ECHM Consensus Conferences.
Conditions where the use of HBO2 was supported by level A, B or C evidence were considered as
accepted indications.
Level A :Level B :Level C :At least 2 concordant, large, double-blind, controlled randomized studies with no or little
methodological bias.
Double-blind controlled, randomized studies but with methodological flaws; studies with
only small samples, or only a single study.
Consensus opinion of experts.

In order to make more transparent the jury discussion and decision, conditions which were notconsidered as accepted indications for HBO2 are also reported with the Jury’s evaluation of the existing
evidence. The scale used in this table is an extension of that used for accepted indications.
Level D :Level E :Level F :Only uncontrolled studies with no consensus opinion of expert.
No evidence of beneficial action, or methodological or interpretation bias preclude any
conclusion.
Existing evidence favors not to use HBO2.

CONDITIONACCEPTED
Level of Evidence
A
B
C

Type I
CO poisoning
Crush syndrome
Prevention of osteoradionecrosis after dental extraction
Osteoradionecrosis (mandible)
Soft tissue radionecrosis (cystitis)
Decompression accident
Gas embolism
Anaerobic or mixed bacterial anaerobic infections
Type II
Diabetic foot lesion
Compromised skin graft and musculocutaneous flap
Osteoradionecrosis (other bones)
Radio-induced proctitis / enteritis
Radio-induced lesions of soft tissues
Surgery and implant in irradiated tissue (preventive action)
Sudden deafness
Ischemic ulcer
Refractory chronic osteomyelitis
Neuroblastoma Stage IV- 12 -

X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X

NON ACCEPTED
Level of Evidence
DEFCONDITIONACCEPTED
Level of Evidence
A
B
C

Type III
Post anoxic encephalopathy
Larynx radionecrosis
Radio-induced CNS lesion
Post-vascular procedure reperfusion syndrome
Limb replantation
Burns >20 % of surface area and 2nd degree
Acute ischemic ophthalmological disorders
Selected non healing wounds secondary to inflammatory
processes
Pneumatosis cystoides intestinalis
Others indications
Post sternotomy mediastinitis
StrokeSickle cell disease
Malignant otitis externa
Acute myocardial infarction
Femoral head necrosis
Retinitis pigmentosa
TinnitiusInterstitial cystitis
Facial (Bell's) palsy
Cerebral palsy
Multiple sclerosis
Fetoplacental insufficiency- 13 -NON ACCEPTED
Level of Evidence
D
E
F

X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X

QUESTION 2
WHAT ARE PRESENTLY THE RECOMMENDATIONS CONCERNING THE PREVENTIVE MEASURES AND
THE TREATMENT OF THE ACCIDENTS INDUCED BY HYPERBARIC PRESSURE?

I - Primary prevention: preventing onset of disease
In that field, common sense, existing legislation, and accepted standards of practice have topalliate the lack of studies following the Evidence-Based Medicine criteria. It is felt that therole of this Jury lies primarily in recommending the harmonization of standards andguidelines for both working and recreational divers, as well as hyperbaric workers, as
promulgated by bodies such as ECHM, EDTC, etc.
This applies to: Fitness to Dive Assessment and Re-assessment, Risk Assessment, Safety
and Emergency Procedures, and Diving Procedures in general.

1- Fitness-to-dive and Medical re-assessment :* The joint ECHM-EDTC fitness-to-dive criteria are an agreed standard for all categories of
diving and hyperbaric work, and should be periodically reviewed for currency. National
standards may require modifications.
* Medical re-assessment includes periodic and post illness/accident assessments.
* Assessment outcomes may include: unfitness, fitness or conditional
Diving/hyperbaric workers have the right to appeal against these decisions.

fitness.

2- Risk Assessment, Safety and Emergency Procedures :* EN ISO 14971 defines the risk management process as being made up of three steps: risk
analysis; risk evaluation; and risk control. These are to be applied to all diving and hyperbaric
activities.
* No single failure should result in a serious accident and this has to be implemented throughappropriate safety plans.
* All responsibilities should be clearly defined and properly assigned or delegated before any
operation.
* For all activities, written current Emergency Procedures (EPs) as well as Standard
Operating Procedures (SOPs) should be prepared in advance in order to minimize theconsequences of failure/accidents; they should be readily available and practiced regularly.
* Both the Regulations and their intent should be observed through education, developmentof a safety-oriented culture, reporting, and obtaining informed consent from participants.

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3- Diving Procedures :Current statements on safety of Diving/hyperbaric exposure are based on the incidence ofclinical DCI; sub-clinical, unreported events, or the biological effects of bubble production
remain unexamined.
The Jury recommends that these parameters/markers are considered in the evaluation of
future diving procedures as by field bubble detection, bubble-induced biological effects,
prospective epidemiological surveys and data collection.
4- Medical Hyperbaric Workers :Medical hyperbaric workers have unique occupational safety issues - DCI incidence is low,
particularly with routine HBO2, and unrelated to gender. With increasing depth, DCI riskincreases. Oxygen breathing and staff rotation are useful preventive measures.
This Jury recommends customized tables to account for these differences, appropriate
fitness standards, and provision of oxygen/enriched oxygen breathing mixtures.
II – Secondary prevention : Shortening duration of disease / Improving outcome
Decompression Accidents are true medical emergencies that should receive the benefit of
specialised treatment in dedicated centres as soon as possible. A specialized centre isconsidered a hospital-based recompression facility with permanent and adequately trained
medical and paramedical staff.
• On-site 100% oxygen first aid treatment (Type 1 recommendation, level C)• On-site fluid administration (Type 1 recommendation, level C)• After immediate stabilization and medical evaluation, the victims of adecompression accident should be immediately directed to the closest specialized
centre (Type 1 recommendation, level C)• In water recompression should never be performed as the initial recompression(Type 1 recommendation, level C)• Major accidents should be treated with hyperoxygenated tables either at moderatepressure ( USN T6) or at high pressure ( Cx 30 HeOx). Minor decompression
accidents (pain only) can be treated with only oxygen recompression tables at 2.8
ATA maximum. (note: this is based on the experience and the good results
observed in commercial diving). (Type 1 recommendation, level C)
As an extension of these general principles the following specific recommendations arepresented by the Jury (Table 2)
III – Tertiary prevention : Reducing long-term morbidity
Treatment of Persistent or Residual Symptoms :At this time a maximum of 10 additional hyperbaric treatment sessions are recommended,based on clinical response, after the initial recompression.
If a clinical plateau has not been achieved by 10 treatments, and there is objective evidenceof ongoing improvement, HBO2 may be continued.
(Type 3 recommendation, level C)
Regarding neurological DCI, as with any neurological injury, conventional rehabilitation
should be started as soon as possible.
(Type 1 recommendation, level C)
However, there are no scientifically valid data on which to base firm recommendations as tothe best modalities/procedures to be adopted. Further research is required using
standardised disability recording systems.

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Table 2 : Management of Dysbaric Diseases:
On SiteFirst Aid
On Site First Aid – Oxygen 100%
On Site First Aid – Fluids (oral)
On Site First Aid – Fluids (IV)No In-Water Recompression

Recommendation
Type 1
Type 1
Type 1
Type 1

Evidence level
C
C
CC

Hospital-based Therapy
HBO
Recommendation
Evidence level
Hyperbaric Tx Hyperoxygenated Tables
Type 1C
Recompression with other Tables (USN 6A, Sat) for
Type 3C
CAGE** or recalcitrant cases
FluidsFluid Therapy in General (Hospital Based)Type 2C
No Fluid Therapy D5W
Type 1
C
Fluid Therapy LR/crystalloids(Pain only/mild)
Type 2
C
Fluid Therapy LR/crystalloids (Chokes)
Type 2
B
Fluid Therapy LR/crystalloids (Neuro DCI)
Type 1
C
Fluid Therapy LR/crystalloids (AGE)
Type 2
B
Fluid Therapy Colloids (Pain)
Type 1
C
Fluid Therapy Colloids (Chokes)
Type 2
C
Fluid Therapy Colloids (Neuro)Type 1
C
Fluid Therapy Colloids (AGE)
Type 2C
Drug Therapy
Recommendation
Evidence Level
Life Support Drug Therapy
Type 1C
Drug Therapy in General
Type 3C
AspirinType 3C
NSAIDs (AGE and Chokes)
Type 3C
NSAIDs (pain only & neurological)
Type 3C
Anti-coagulants(AGE,Neurological)* Chokes)
Type 3C
No Anticoagulants (pain only)
Type 1C
Anticoagulants (DVT prevention leg immobility)*Type 1A
No Corticosteroids
Type 1C
Lidocaine (AGE)
Type 2B
Lidocaine (neuro DCS)
Type 3
C
No Lidocaine (pain only, chokes)
Type 1C* avoid complete decoagulation** The use of USN 6A table should be limited to cases of CAGE caused by emergency ascent procedure without
any previous compressed gas exposure leading to gas tissue supersaturation.

- 16 -QUESTION 3
WHAT ARE PRESENTLY THE RECOMMENDATIONS CONCERNING THE ORGANIZATION AND PRACTICE
IN A THERAPEUTIC CHAMBER?

* The Jury strongly recommends that the European Code of Good Practice for Hyperbaric
Oxygen Therapy (ECGP) be the minimum requirement to be fulfilled by European hyperbaric
centres, as it was established by a large consensus between internationally recognizedEuropean experts. (Type 1 recommendation, level C)* The hyperbaric therapeutic facilities enter one of the following categories:- hospital based or hospital connected.
- stand-alone.
Stand-alone facilities can treat patients not critically ill, but must be capable of providing carein case of clinical complications. Facilities standing on diving sites can treat patients sufferingfrom acute decompression illness, provided their staff and equipment comply with minimum
education and safety levels according to ECGP. (Type 2 recommendation, level C)* The operations must be conducted under Standard Operation Procedures described in a
specific manual. Each hyperbaric centres must develop emergency procedures on the sameway. The staff must review these regularly, and should be trained in these procedures. (Type
2 recommendation, level C)* There is a large consensus to state the minimum team size for a hyperbaric session:- 3 persons for a multiplace chamber:- physician- attendant- operator- 2 persons for a monoplace chamber:- physician- operator.
(Type 1 recommendation, level C)
Furthermore, a person for emergency assistance must be available in the vicinity.
(Type 2 recommendation, level C)* It is the duty of a hyperbaric centres to actively participate in continuous education andtraining of personnel. (Type 1 recommendation, level C)* Hyperbaric centres should cooperate in research in hyperbaric and/or diving medicine.
(Type 3 recommendation, level C)* Hyperbaric centres should participate in education and examination of hyperbaric workers
and divers (preventive medicine) and act as a referral for employees and contractors as
centres of competencies, in respect of their national regulations. (Type 3 recommendation,level C)* Every hyperbaric centre must develop and maintain a high level of safety for patients, staff
and environment, based on risk prevention, education and appropriate procedures. (Type 1
recommendation, level C)- 17 -QUESTION 4
WHAT ARE PRESENTLY THE REQUIREMENTS CONCERNING THE DESIGN AND THE SAFETY OF
THERAPEUTIC HYPERBARIC CHAMBERS AND THEIR RELATED MEDICAL DEVICES?

* A therapeutic hyperbaric chamber shall be considered a medical device according to theEuropean Council Directive 93/42 “medical products”.
* The performance, testing and safety requirements of new therapeutic multiplace chambersystems shall conform with the new European norm prEN 14931 CEN TF 127 . All newchambers will be CE marked. Existing chambers should strive to reach the same safetylevels as required by that norm. (Type 1 recommendation, level C).
* Quality assurance should be implemented in hyperbaric centers. (Type 1 recommendation,level C)* Approval of medical devices for hyperbaric use is a worldwide problem. With a few
exceptions, there is a lack of CE marked medical devices for use in the hyperbaric chamber.
A risk evaluation according to the European norm ISO 14971 should be performed before
bringing medical equipment into the chamber. Publishing and sharing experience andinformation on risk analyses between European HBO2 centres is recommended. The
manufacturers shall be encouraged to extend the CE approval of their medical devices for
hyperbaric use. (Type 1 recommendation, level C)* Oxygen filled “monoplace chambers” may be accepted and used according tointernationally accepted guidelines. (Type 3 recommendation, level C)

QUESTION 5
WHAT ARE PRESENTLY THE REQUIREMENTS CONCERNING THE MANAGEMENT OF PATIENTSTREATED WITH HBO2?

* A hyperbaric facility should be hospital based or functionally linked to a hospital. (Type 1
recommendation, level C)* Standard operating procedures for the management of patients treated in hyperbaric
facilities should follow the European Code of good practice for HBO2 therapy. (Type 1
recommendation, level C)* Appropriate monitoring equipment for selecting, supervising and follow-up of patients andtheir clinical response to HBO2 treatment is required. (Type 1 recommendation, level C)* HBO2 treatment of intensive-care patients (with one or more organ failures that threaten
vital functions) requires continuing monitoring and management according to standard
European intensive care recommendations. The hyperbaric facility shall be located as close
as possible to the Intensive Care Unit to minimize risks. (Type 1 recommendation, level C)- 18 -QUESTION 6
WHAT ARE PRESENTLY THE REQUIREMENTS CONCERNING THE INITIAL AND CONTINUOUSEDUCATION OF THERAPEUTIC HYPERBARIC CENTRE STAFF?

* Co-operation between the ECHM and the EDTC has been fruitful.
* A curriculum drawn up for different categories of hyperbaric personnel, describing the levelsof competence according to the professional job, is strongly recommended. (note 1). (Type 1
recommendation, level C)* A core curriculum of modular teaching, applicable to all hyperbaric personnel (medical andnon-medical) is strongly recommended. (note 2). (Type 1 recommendation, level C)* Education based on a modular system should be obtainable in different teaching institutions
throughout Europe, with mutual recognition to the core standard. A system of credits, basedon the minimal duration and emphasis of teaching elements, is strongly recommended. Entry
criteria for the education of hyperbaric medical personnel will depend on the competency
ultimately required for the category of the job. (note 3). (Type 1 recommendation, level C)* For the education of a hyperbaric medical expert, an in-depth study of particular aspects ofhyperbaric medicine (ie a dissertation) is strongly recommended. (Type 1 recommendation,level C)* The European College of Baromedicine, as supported by the ECHM, should provide
validation and accreditation for education and training in European countries. (note 4). (Type
1 recommendation, level C)* A programme for the education and training of non-medical hyperbaric personnel should be
developed by an association of non-medical professionals (for example EBASS) in
collaboration with the ECHM. (Type 1 recommendation, level C)* Continuing professional development using a format such as Continuing Medical Education(CME) is essential. (Type 1 recommendation, level C)

note 1. A curriculum has been drawn up by the COST Action B14 Education Working Group,
based on the ECHM/EDTC proposals.
note 2. The core curriculum will be the result of the current work arising from COST Action
B14 Education Working Group, due to be published through the ECHM.
note 3. Precise entry criteria for all hyperbaric personnel are being developed through the
COST Action B14 Education Working Group, based on the recommendations of the
ECHM/EDTC.
note 4. The accreditation body should work according to robust and transparent principles,with representation from the participating countries.

- 19 -QUESTION 7
WHAT MAY BE PRESENTLY RECOMMENDED CONCERNING THE RESEARCH IN HYPERBARIC
MEDICINE FOR THE NEXT FUTURE?

* It is strongly recommended that personnel (member) of hyperbaric facilities will associate
into multi-disciplinary teams with specialist in other fields and basic scientists (Type 1
recommendation, level C)* It is strongly recommended that medical staff involved in Hyperbaric Medicine receive
training in basic and clinical research methods on a continously regular base (e.g. CME).
(Type 1 recommendation, level C)* It is strongly recommended that a network of multicentric basic and clinical research is
implemented. (Type 1 recommendation, level C)* It is strongly recommended that European Ethical and Research Committees have to becontinued within the European Committee for Hyperbaric Medicine with 2 priorities :- establishment of a directory of centers and teams involved in clinical and basic
research related to hyperbaric medicine.
- organization of seminars and workshops dedicated to clinical and basic researchtraining.
(Type 1 recommendation, level C)* It is strongly recommended that information and personnel exchange policies between
hyperbaric facilities are implemented (Type 1 recommendation, level C)- 20 -