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Eur Respir J 1989, 2, 160-164
Report of a SEP (European Society of Pneumology) Task Group
Recommendations for long term oxygen therapy (LTOT)
This statement was. developed and modified in a meeting of the task group held on 7th S~ptem_ber 198~ 1n Bu~apes~. (VII Congress of Societas Europaea Pneumologica)
Cha1rman. P. Lev1 Valens1 (Am1ens, France) Members: P. Aubry (Amiens, France) C.F. Donne~ (Veruno, Italy}, D. Robert (Lyon, France}, K.H. Ruhle (Hagen, FRG},'
E. We1tzenblum (Strasbourg, France), R.Wurtemberger (Freiburg, FRG)
The aims of L TOT are the following: - Correction of hypoxaemia without inducing danger-
ous hypercapnic acidosis - Improvement of survival - Reduction of polycythaemia - Improvement of neuropsychological status - Improvement of sleep quality and prevention of
nocturnal hypoxaemic dips - Prevention of right heart failure - Improvement of quality of life - Reduction in health costs (frequency and days of
hospitalization)
Facts - some reminders
The MRC [1] and NOTT [2] studies are the only controlled investigations using L TOT in chronic obstructive pulmonary disease patients (COPD). These studies have clearly demonstrated a significant survival difference between treated and untreated groups. The daily requirement of oxygen therapy has been stated to be at least 15 hours. Greater clinical benefit can be expected if the treatment is applied for at least 18 h per day. No randomized or controlled studies have been made in patients with disease other than COPD, in particular restrictive lung disease (fibrosis, pneumoconiosis etc.) where LTOT is commonly used by some groups.
The effect of LTOT on haemodynamic parameters has been studied by TIMMS [3], WEITZENBLUM [4] and AsmrrosH [5, 6]. WEITZENBLUM [4, 7] demonstrated that LTOT can reverse the progression of pulmonary hypertension in COPD patients and TIMMS [3] using NOTT study observations, confirmed the value of continuous LTOT.
More recently, SLINGER [8] demonstrated the effect of removing oxygen in obstructive pulmonary disease. AsmrrosH [6] confirmed his first study [5] on haemodynamic effects of oxygen administration and its application to long term prognosis and suggested a non invasive test of responsiveness of pulmonary hypertension to oxygen.
The group are grateful to P. Howard (Sheffield UK) for constructive criticsm and help in preparing the final version.
It is well known that hypoxaemia plays a different ~ale during the day from that during sleep, especially m blue and bloated patients with day time Pao <8kPa (60 mmHg) [9, 10]. The improvement of n~tumal hypoxaemia and its haemodynamic consequences have been reported by many authors [7, 11, 12, 13]. FLETCHER and LEVIN [14] who studied the acute and three week effects of oxygen breathing showed oxygen administration to prevent desaturation episodes and paroxysmal pulmonary hypertension. Recently, FLETCHER
[15] demonstrated that patients with day time Pao above 8 kPa (60 mmHg) can still have nocturnal hypoxaemia. The risk is higher for patients with day time Pao
2 between 8 and 8.7 kPa (60 and 65 mmHg)
who are on the steepest part of the oxyhaemoglobin dissociation curve. The mechanism of desaturation during sleep in COPD patients is related to two causes, REM sleep and the overlap syndrome [FENLEY 13, 16]. In the overlap syndrome, desaturations are either related to REM sleep or associated with obstructive sleep apnoea in non REM sleep. In some of these patients oxygen reduces desaturation but increases the number of sleep apnoea episodes.
The role of respiratory stimulants in the management of hypoxic patients is unclear. Almitrine improves Pao [17] but its effects on haemodynamic parameters ar~ controversial [18]. Different authors question the feasibility of combining LTOT with drugs [19, 20].
It is not therefore possible to standardize every aspect of LTOT and these difficulties have led to a wide variability in indications and operating conditions among prescribing Physicians.
In this short report we will deal with some of the recommendations for selection of patients, choice of oxygen supply and methods of administration.
Selection of patients
Selection of criteria
Pao2
is an important criterion for the selection of patients but an occasional single measurement of Pao is not a definitive indication for LTOT. Selectio~ criteria must include determination of a steady state [1, 2, 21, 22, 23], the use of suitable pharmacological
TASK GROUP REPORT 161
Table 1. - Choice of investigations before considering L TOT
Test Always nw.my
According to clinical circumstances and Pao2 levels
Clinical and radiological · Spirometry Daytime blood gas at rest Hb, Het Exercise testing Haemodynamics
Polysomnography (including EEG, EOG, EMG, Sao2,
airflow, rib cage and abdominal movements)
Hb: haemoglobin, Het: haematocrit
therapy (ATS guidelines, November, 1986), chest physiotherapy and preventive measures such as the stopping of tobacco. The need for a probationary period is clearly shown by follow up studies. Blood gas measurements in patients after an acute exacerbation Pao2<7.3kPa (55 mmHg), may improve even after demonstration of an apparent steady state [21, 22, 23, 24]. The circumstances are different after an acute exacerbation than during long term management of COPD. For Pao2 levels between 6. 7 and 7 .3kPa (50 and 55 mmHg) a delay from one to three months is recommended.
Methods of investigation
Investigations to be considered before LTOT are: clinical and radiological examination, blood gas measurement, haematocrit, exercise testing, haemodynamic investigation and sleep recording. Not all of these investigations are necessary in every case but should be chosen according to th.e clinical circumstances and Pao2 level (table 1).
Assessment of oxygen efficiency and tolerance: Oxygen tests
The patients should receive continuous LTOT and the dose should be sufficient to raise resting Pao2 to 8.7-10.7kPa (65-80 mmHg) by, selecting the most appropriate flow rate. In patients with hypoxaemic episodes during sleep or exercise the flow selection tests should be made according to the clinical picture and the response to the administered 0 2 dosage reassessed periodically (table 2).
Indications for L TOT
Indications usually admitted:
After a probationary period with chest physiotherapy, stopping tobacco and drug treatment steady state COPD
+ + + + + Pao
2 7.3- 8.7kPa (55-65 mmHg)
Pao ;?: 7.3kPa (55 mmHg) during The day with polycythaemia, sleep desaturation or exercise desaturation (when possible)
Pao2
7.4-8.7kPa (56-65 mmHg) wit.li polycythaemia or chronic cor pulmonale. Snoring obese COPD patients (when possible)
patients with Pao2<7.3kPa (55 mmHg) according to MRC and NOTI criteria.
Questionable indications
a) Currently accepted - COPD with Pao2 7.3-8.7kPa (55--65 mmHg) with:
- polycythaemia or - clinical evidence of cor pulmonale or - pulmonary hypertension
In this group of patients other investigations are necessary: haemodynamics, sleep recording, exercise testing
Controversial
b) Restrictive lung disease (interstitial pulmonary fibrosis, pneumoconiosis) with Pao2<7.3k.Pa (55 mmHg)
Choice of 0 2 supply
The choice of source depends on the duration of utilisation, the oxygen flow rate required, the possibility of ambulatory use, the geographical area of residence and the patient's interest in both physical and social activities (table 3).
Methods of administration
Conventional methods
Nasal prongs. This method is simple and inexpensive and the most commonly used delivery system for 0 2 at flow rates up to 4 l·min·1•
The continuous 0 2 flow is usually related to the instantaneous inspiratory flow, consequently the tracheal F10
2 varies during the inspiratory phase.
Under a flow rate of 3 l·min·1 this method is usually
162 P. LEVI V ALENSI
Table 2. - Oxygen tests
Test available
Blood gases at rest, breathing room air and oxygen Determination of flow rate
Sleep recording during room air and oxygen breathing Sao2, Ptcco2 or blood gases by arterial puncture 4 h after the onset of sleep, as quickly as possible with apnoea detection
Tolerance and efficacy
Exercise, 12 min walking test (McGavin) with determination of 0 2 flow rate and carrying capacity
Exercise test in steady state
Haemodynamics and/or Vo2
symptom limited to distinguish responders and indicate prognosis. ~PAP> 5 mmHg Vo
2 <6.5 ml·min-1-Kg-1
(New selection criteria suggested by AsHUTOSH) [6]
well tolerated and the gas does not require humidification. Higher flows may be uncomfortable due to dryness of the nasal mucosa and may be responsible for local irritation and sometimes bleeding.
Aesthetic qualities are poor. Efficacy is disrupted either when prongs are displaced (during sleep) or during oral breathing (exercising, speaking, sleeping).
Naso-pharyngeal chatheters. These devices may improve the efficiency of oxygenation in case of oral breathing but are seldom used at home. Oxygen humidification and periodic changes are necessary and aesthetic appearance is poor.
Simple masks. They are seldom used at home. The dead space of the mask may increase Paco2 and require higher 0 2 flow rates (above 5 l·min-1) . They do not permit eating or speaking, are usually not well tolerated and appearance is obstrusive.
Non conventional methods
Trans-tracheal catheter. Trans-tracheal oxygen therapy was first proposed by HEMUcH in 1982 [25]. Since that time more than 3,000 patients have been treated. The principle of the method is to deliver 0 2 into the trachea 2 cm above the carina through a small catheter (1 to 2 mm of internal diameter) inserted percutaneously at the level of the first tracheal ring.
Always necessary
+
+?
According to clinical diagnosis and Pao
2 level
Snoring obese patients, Pao2>8.7kPa (65 mmHg), morning headache
Patients who develop hypoxaemia during exercise
Pao2 7.3-f>.7 kPa (55-65 mmHg)
Trans-tracheal catheters have a number of advantages: The reduction of the 0 2 flow by approximately 50% compared with the conventional nasal route.
Oxygenation does not vary with the pattern of breathing
Enables 24 h·day of use and consequently maximum efficacy is obtained at all times
A major advantage is the cosmetic quality of the method since the catheter insert at the level of the neck can be totally concealed
Conversely the method has some disadvantages: - it is invasive, needing a procedure to insert the catheter into the trachea (30 min), - requires close supervision during the first weeks and education of the patient to enable him to take care of his own treatment, and - a big problem and sometimes a real hazard, is the fonnation of mucous balls made of dried secretions attached to the catheter. They may decrease the efficiency of oxygenation or hinder ventilatory flow.
They are suitable for patients requiring high 0 2 flow rates (>3 1-min-1) or for the very anxious who wish to appear as normal as possible without 0 2 lines on the face.
Oxymiser. This device uses a small reservoir (20 ml) inserted in the 0 2 line which fills with pure 0 2 during the expiratory period to be inhaled at the very beginning of the following inspiration [23, 26]. Tbe
TASK GROUP REPORT
Table 3. - Choice of criteria for supply source of LTOT
Supply source
Gaseous oxygen
Fixed cylinders
Portable cylinders
Liquid oxygen
Fixed system
Portable system
Oxygen concentrators
Advantages
Tried and tested system Operating delivery circuits
Operating delivery circuits
May be used in conjunction with a concentrator
Useful in rehabilitation programmes
Great reserve supply Refilling less frequent
Reserve supply greater than gaseous source Useful in rehabilitation programmes
No delivery circuits The least onerous solution
Disadvantages
Fixed supply Frequent replacements or large storage area
Refilling difficulties (changing manometers) Limited period of use
Possible psychological reticence in outside use
Evaporation losses Necessity to organise delivery circuits Necessity to treat at least 20 patients to minimise costs
The same for fixed system Possible psychological reticence in outside use
Fixed installation or only partially mobile No possibility of use for physical activity Needs regular maintenance using technical assistance Not useful in rehabilitation programmes
Preferential indication for use
Technique used less and less Possible renewal of interest with oxygen conserving device
Patients with a limited
l63
capability of perambulation Complementary use with concentrator
Patients unable to leave home
Patients with reasonable possibility of perambulation Rehabilitation programmes When patient is strongly motivated towards his treatment and his normal social life
Patients unable to leave home Oxygen therapy 15-18 h maximum Unfavourable geographical areas (difficult access mountain regions etc)
reservoir may be positioned either under the nose like a moustache or in a pendant at the level of the thorax. 0 2 is delivered with nasal prongs. This system may save from 30% to 50% of the 0 2 supply dependent on the flow rate. Used during ambulation the portable 0 2 source may last longer. ARLA11 [27] demonstrated that reservoir nasal prongs improve protection against desaturation during exercise in COPD.
- Exercise hypoxaemia with day time normoxia
Pulsed demand valve. The principle is to deliver 0 2 only at the beginning of the inspiratory phase avoiding 0
2 wastage. The valve is triggered either by tempera
ture or more recently by the negative pressure of early inspiration [18]. Oxygen savings may reach more than 50%. A demand valve may be incorporated in all supply sources. It may be used either in a sedentary position or during ambulation [22].
The future. We need further investigations into the following fields: - Sleep related disorders causing hypoxaemia but with
out day time hypoxaemia
- Patients with fibrosis and pneumoconiosis
References
1. MRC Working Party. - Long-term domiciliary oxygen therapy in chronic hypoxic cor pulmonale complicating chronic bronchitis and emphysema. Lancet, 1981, 1, 681-186. 2. Nocturnal oxygen therapy trial group. - Continuous or nocturnal oxygen therapy in hypoxemic chrof!ic obstructive lung disease. A clinical trial. Ann Intern Med, 1980, 93, 391-398. 3. Timms RM, Khaja FU, Williams GW. - Hemodynamic response to oxygen therapy in chronic pulmonary disease. Ann Intern Med, 1985, 102, 29-36. 4. Weitzenblum E, Sautejeau A, Ehrahrt M, Mammosser M, Pelletier A.·- Long-term oxygen therapy can reverse the progression of pulmonary hypertension in patients with chronic obstructive pulmonary disease. Am Rev Respir Dis, 1985, 131, 493-498. 5. Asthutosh K, Mean G, Dunsky M. - Early effects of oxygen administration and prognosis in chronic obstructive
164 P. LEVI VALENSI
pulmonary disease and cor pulmonale. Am Rev Respir Dis, 1983, 127, 399-404. 6. Ashutosh K, Dunsky M. - Noninvasive tests for responsiveness of pulmonary hypertension to oxygen. Chest, 1987, 92, 393-399. 7. Weitzenblum E, Muzet A, Enrhart M, Ehrhart J, Sautejeau A, Weber L. - Variations nocturnes des gaz du sang et de la pression arterielle pulmonaire chez les bronchitiques chroniques insuffisants respiratoires. Nouv Pr med, 1982, 11(15), 1119-1122. 8. Selinger SR, Kennedy TP, Buescher P, Terry P, Parham W, Gofreed D, Medinger A, Spagnolo SV, Michael JR. -Effects of removing oxygen from patients with chronic obstructive pulmonary disease. Am Rev Respir Dis, 1987, 136, 85-91. 9. Douglas NJ, Legget RJE, Calverley PMA, Brash HM, Henley DC, Brezinova V.- Transient hypoxernia during sleep in chronic bronchitis and emphysema. Lancet, 1979, 1, 1-4. 10. De Marco FJ, Wynne JW, Block AJ, Boysen PG, Taasan VC. - Oxygen desaturation during sleep as a determinant of the "blue and bloated" syndrome. Chest, 1981, 76(6), 621-625. 11. Boysen PG. - Nocturnal oxygen therapy and hemodynamic changes in COPD. Chest, 1984, 85(1), 2-3. 12. Coccagna G, Lugaresi E. - Arterial blood gases and pulmonary systemic arterial pressure during sleep in chronic obstructive pulmonary disease. Sleep, 1978, 1, 117-124. 13. Flenley DC. - Sleep in chronic obstructive lung disease. Clin. Chest Med, 1985, 6, 651-661. 14. Fletcher EC, Levin DC. - Cardiopulmonary haemodynamics during sleep in subjects with chronic obstructive pulmonary disease: the effect of short and long term oxygen. Chest, 1984, 85, 6-14. 15. Fletcher EC, Miller J, Divine J, Fletcher J, Miller T. -Nocturnal oxyhemoglobin desaturation in COPD patients with arterial oxygen tension above 60 mmHg. Chest, 1987, 92(4), 604-608. 16. Flenley DC. - Long-term home oxygen therapy. Chest, 1985, 87, 99-103. 17. Voisin C, Howard P, Ansquer SC.- Alrnitrine bismesylate: a long term placebo-controlled double-blind study in COAD, Vectarion international multicentre study group. Clin Respir Physiol, 1987, 23(11), 169s-182s. 18. MacNee W, Connaughton JJ, Rhind GB, Hayhurst MD, Douglas NJ, Muir AL, Flenley DC. - A comparison of the effects of almitrine or oxygen breathing on pulmonary arte-
rial pressure and right ventricular ejection fraction in hypoxic chronic bronchitis and emphysema. Am Rev Respir Dis, 1986, 134, 559-565. 19. Howard P.- Drugs and oxygen for hypoxic cor pulmonale. Pr med, 1983, 287, 1159-1160. 20. Winkelman BR, Henrich F, Ansquires JC. - Acute effects of supplements of oxygen during almitrine therapy on hemodynamic and pulmonary gas exchange. Am Rev Respir Dis, 1988, 137, 137-138. 21. Levi-Valensi P, Weitzenblum E, Pedinielli JL, Racineux JL, Duwoos H. - Three months follow up of arterial blood gas determination in candidates for long term oxygen therapy. Am Rev Respir Dis, 1986, 133, 547-551. 22. Reybet Degat 0, Dumas JP, Camus PH, Nonciaux C, Jeannin L. - Selection of patients with chronic obstructive pulmonary disease for long-term oxygen therapy: evolution of blood gases values after hospital care for acute respiratory failure. Eur J Respir Dis, 1986, 69 (146 A), 136. 23. Tirnms RM, Kvale RA, Anthonisen NR, Boylen CT, Cugell DW, Petts TL, Williams GW. - Selection of patients with chronic obstructive pulmonary disease for long-term oxygen therapy. lAMA, 1981, 245, 2514-2515. 24. Midgren B, White T, Peterson K, Bryhn M, Airikkala P, Elmquist D. -Nocturnal hypoxemia and cor pulmonale in severe chronic lung disease. Bull Eur Physiopathol Respir, 1985, 21, 527-533. 25. Heirnlich HJ, Carr GC. -Transtracheal catheter technique for pulmonary rehabilitation. Ann Othol Rhino/ Laryngol, 1985, 94, 502-504. 26. Tiep BL, Carter R, Nicotra B, Berry J, Phillips RE, OTSEP B.- Demand Oxygen delivery during exercise. Chest, 1987, 91(1), 15-20. 27. Arlati S, Rolo J, Midallef E, Sacerdoti C, Brambilla I. - A reservoir nasal cannula improves protection given by oxygen during muscolar exercise in COPD. Chest, 1988, 93, 1165-1169. 28. Robert D, Leger P, Perrin F. - Evaluation of an intermittent flow oxygen system. Bull Eur Physiopath Respir, 1986, 22, 315-318. 29. Tiep BL, Nicotra B, Carter R, Belman MS, Mittrnan C. - Evaluation of a low-flow oxygen-conserving nasal cannula. Am Rev Respir Dis, 1984, 130(3), 500-502. 30. Levi-Valensi P, Duwoos H, Weitzenblum E, Pedinielli JL, Aubry P, Fourquet B. - Bilan prealable et indications de !'assistance ventilatoire a comicile. Rev Fr Mal Respir, 1979, 7, 331-340.