Ltot gøteborg 2008

Oxygenterapi i Norden och i världen

Thomas Ringbæk, Hjerte-lungemed. afd. Hvidovre, København

Overview Types of home oxygen therapies (terminology) Evidence: a) COT

b) STOT (unstable condition)c) SBOT (short burst of oxygen)d) NOT (nocturnal oxygen)e) ambulatory & portable oxygen

How do we do in practice?Home Oxygen Therapy in various countries:

a) guidelinesb) practice/organisation c) qualityd) prevalence/incidence e)

survival

The Terminology of Home Oxygen Therapy

The Terminology of Home Oxygen Therapy

COT in COPD: effect on survivalPaO2 <7.3 kPa;7.3-8.0: EVF>55% or cor pulmonale)

Post-PaO2 >8.6 kPa; Stabile and optimal treated; Non-smokers

MRC NOTTN 87 203Age 58 66Men% 76 80FEV1% 30 30PO2, 6.8 6.8 kPaPCO2 7.2 6.9 kPaHtc.% 52 47Smoking 45% ?Flow 2 1-3+1Hours 13.5 17.7/12Mobile - +/-

COT in non-COPD

Lung fibrosis: 62 patients. No effect on survival.Unpublished data.

Crockett AJ et al. Domiciliary oxygen for interstitial lung disease. Cochrane Database Syst Rev 2001; 3:CD002883

RCT on moderate hypoxaemic COPD patients 1987-92 in Poland1987-92 in Poland 135 COPD patients with P135 COPD patients with PaaOO22 7.4-8.7 kPa. 7.4-8.7 kPa. Post-PO2 >8.7 kPa (mean 9.9 kPa)Post-PO2 >8.7 kPa (mean 9.9 kPa) >17 hrs/day vs. no oxygen (used 13½ hrs)>17 hrs/day vs. no oxygen (used 13½ hrs) Only concentratorOnly concentrator Not assessed: QoLNot assessed: QoL

Daily activity/exerciseDaily activity/exerciseHospitalisationHospitalisation

RCT on moderate hypoxaemic COPD patients (planned study) 3.200 COPD pts. in USA3.200 COPD pts. in USA

Usual careUsual care Sat.OSat.O22 89-93%: 89-93%:

LTOT+ portable oxygenLTOT+ portable oxygen

Outcomes: QoLOutcomes: QoLDaily activity/exerciseDaily activity/exerciseSurvivalSurvival

The Terminology of Home Oxygen Therapy

STOT (oxygen at home while unstable)

Re-evaluation: 1 month later: normalised in 30%1 and 70%2

2-3 months later: 30-50% normalised1,3

PO2<6.7 kPa: only 1 of 23 normalised1

Despite LTOT: 17% died <2 months4

No RCT

1) Levi-Valensi et al. Am Rev Respir Dis 19862) Andersson et al. Respir Med 20023) NOTT study4) Eaton et al. Respir Med 2001

The Terminology of Home Oxygen Therapy

SBOT (palliation of attacks of dyspnoea)

Very few studies1,2

Only mentioned superficially in BTS, ATS, GOLD COPD: 6-12 wks: 4 studies (PO2 8.5-10 kPa):

2 showed a small effect compared to air. Cancer:

+hypoxaemia at rest: 5 L O2/min > air.

- hypoxaemia at rest: 4 L O2/min= 4 L air/min

1) Booth S et al.Respir Med 20042) Booth S et al. Am J Respir Crit Care Med 1996

The Terminology of Home Oxygen Therapy

Scenaries with hypoxaemia

% SAT.O2

95 90 85

nat Flyvning anstrengelse/anfald

7 timer 3-8 timer 0,5-2 timer

Rationale for Nocturnal Oxygen Therapy

Appr. 30% had nocturnal desat.1

Assoc. with Pulm.AP & mortality2,3 In the NOTT was correction of 7 hours hypoxaemia related to

survival

1) Fletcher EC et al. Chest 19872) Fletcher EC et al. ARRD19893) Fletcher EC et al. Chest 1992

Effects of Nocturnal Oxygen Therapy

Chaouat A et al. Eur Respir J 2001

35 desat. (>30% time with desat <90%)

Vs. 29 non-desat

The Terminology of Home Oxygen Therapy

Portable Oxygen devices

Concentrator Cylinders Liquid ”on-demand” valves

Aims of portable and ambulatory oxygen

Portable Oxygen (hypoxaemic at rest) hrs on oxygen

daily activity

Ambulatory Oxygen (normoxaemic at rest)

Desaturate and/or dyspnoea during exercise

exercise tolerance/daily activity

Portable oxygen in 159 COPD pts on COTFrance 1984-6; presc. >15 hrs/day; 12 MWD>200 m

Flow: 1.7 L/min at rest and 2.2 L/min during exercise. Randomised.

Gr.A=75Gr.A=75 Gr.B=84Gr.B=84 CConc.onc. Conc+small cyl.*(51)Conc+small cyl.*(51) Liquid(33)Liquid(33)

12MWD –O12MWD –O22 407 m407 m 337337 (423)(423) 546546

12MWD+O12MWD+O22 485 m485 m 370370 (478)(478) 628628

Hrs/day:Hrs/day: 14 hrs14 hrs 17 hrs 17 hrs (B1 = B2) <0,01 (B1 = B2) <0,01

Outdoor with OOutdoor with O22: : 55%55% 67%67%

Indoor:Indoor: equalequalActivity indoor: Activity indoor: equalequalActivity outdoor: Activity outdoor: equalequal 25% did not use portable oxygen, and 15% only indoor. 25% did not use portable oxygen, and 15% only indoor. Too heavy according to the patient: Cyl.: 50%, Liquid: 33%Too heavy according to the patient: Cyl.: 50%, Liquid: 33%

*) 2½ L cyl. + stroller (used by 10% of the pts) Vergeret J. Eur Respir J 1989

Portable oxygen in 15 COPD pts on COTLondon; <1992; oxygen +10% exercise tolerance and/or dyspnoea;

Flow: 2 L/min. 8 weeks; randomised and cross-over.

Cylinders(2½-3½ kg) Liquid

6MWD t=0 255 m (median) 250 m

           8 wks on O2: equal

Dyspnoea after walk equal

Usage of oxygen: 10 hrs/wk 23,5 hrs/wk*

Outdoor activity: 15 hrs/wk 19,5 hrs/wk*

Preferred by patient: 4 11

QoL (CRQ): equal

Usage of stationary O2: 114 hrs/wk 99,6 hrs/wk

Sum of usage: equal (appr. 17 hrs/day)

Lock SH. Thorax 1992

Effect and usage of portable oxygen in COPD pts on COT

COT: 3-12 months

Excluded pts. who were not expected to live > 1 year.

Conc.: 3 mdr. Conc.+O2: 3 mdr. Conc.+O2:3 mdr.

Lacasse Y, ERJ 2005

Effects and use of portable (2½ kg) oxygen in 24 COPD pts on LTOT. 3 x 3 months

•No effect on QoL and 6 MWD

Lacasse Y, ERJ 2005

Portable oxygen in COT patientsThe Netherlands 1992; 528 pts. 70% COPD; presc. 15.8 hrs/day; COT >½ år

63% had portable oxygen (19% liquid). 27% had no usage; 16% sporadic usage.

Liquid>Cylinders. Only about 18% carried the device themselves. Only 20% used the oxygen outdoors

Kampelmacher MJ el al. Respir Med. 1998

Categories of complaints due to COT

The Netherlands; 1992; 528 pts; COT >½ year

0 10 20 30 40 50

Restricted autonomy

Delivery device

Oxygen source

Feeling ashamed

Treatment duration

%

Conc.: 55%

Cyl.: 34%

Liquid:35%

Kampelmacher MJ, Respir Med 1998

81% at least one complaint

Non-compliance was ass. with “feeling ashamed“

Usage of portable oxygen in 125 COPD patients on COT

OutdoorsOutdoors

65%65%

Not outdoorsNot outdoors

35%35%

Portable oxygen Portable oxygen (38%)(38%)

48%48% 21%21%

Usage hrs/dayUsage hrs/day 1,321,32 1,131,13

>2 hrs/week,%>2 hrs/week,% 4949 2222

Ringbæk; Respir Med 199927% had no usage 27% had no usage during 3 monthsduring 3 months

Portable oxygen in 930 COPD pts on COTFrance before 1996; Presc. 16 hrs/day; COT >3 months

Portable oxygen to 30% of 893 ptt. with a concentrator. Only used by 52% in a 3 months period Only used outdoor by 4% –

especially those with liquid oxygen

Pepin JL et al. Chest 1996

Ambulatory oxygen

Ambulatory oxygen to pts with desat. and/or dyspnoea. Prevalence in COPD

10% desaturate ≥4% 10% desaturate ≥4% 5.926 COPD pts with FEV5.926 COPD pts with FEV11 1.5-2 L (1) 1.5-2 L (1)

32% desaturate ≥4% and 32% desaturate ≥4% and 88% 88% 81 COPD pts with FEV81 COPD pts with FEV11 =1,29 (2) =1,29 (2)

1. Hadeli KO et al. Chest 2001;120;88-92 1. Hadeli KO et al. Chest 2001;120;88-92

2. Knower MT et al. 2. Knower MT et al. Arch Intern Med 2001;161:732-6Arch Intern Med 2001;161:732-6

The clinical relevance of desaturation during exercise?

Desat. is poorly assoc. tol 6-MWD and dyspnoeaDesat. is poorly assoc. tol 6-MWD and dyspnoea

1. Mak VH et al. Thorax 1993;48(1):33-81. Mak VH et al. Thorax 1993;48(1):33-82. Baldwin DR et al. Respir Med 1995;89(9):599-6012. Baldwin DR et al. Respir Med 1995;89(9):599-601

Pulmonal hypertension, hospitalisation, and mortality?Pulmonal hypertension, hospitalisation, and mortality?(like nocturnal desaturation)(like nocturnal desaturation)

Acute effect of ambul.oxygen

Borg dyspnoea score 0.5-1.0

Physical tolerance 5-20%

+

Weight of device

Risk of stumbling over the tube

Shamed

-

• No effect of oxygen pre- or post-exerciseKillen JWW, Thorax

2000Lewis CA, ERJ 2003McKeon JL, Thorax

1988Stevenson NJ, Thorax.

2004

Effect of ambul. oxygenCombination with rehabilitation

No effect Garrod R, Thorax 2000 Emtner M, AJRCCM 2003 Rooyackers JM, ERJ 1997 Wadell K, J Rehabil Med 2001

Puhan MA Respir Res 2004

Effect of ambul. oxygen

26 COPD; FEV1 0.9 L; PO2: 7.8-10.9 kPa; Dyspnoea during exercise; desat. not required 6 wks cross-over; 4 L/min O2 or air; DB

6 wks Air 6 wks O2 P-value Steps: 30 33 NS

Borg 4.3 4.0 NSDesat.4.1% 4.7% NSCRDQ86 91 NS

McDonald CF et al. AJRCCM 1995

Effect of ambul. oxygen

12-week double blinded randomized cross over study. Desat. ≤88%

4 L/min; 2 kg

Eaton ERJ 2002

Acute- and short-term effect of ambul. oxygen on 6 MWD and (acute) and QoL (short-term)

At the end of the study, 14 of 34 responders (41%) were not interested in the ambul. oxygen therapy due to side effects.

Ambulatory oxygen

Unpublished data American study stopped before scheduled Nine months: 22 of 100 expected COPD pts Inclusion: PO2<60 mmHg (most had >60 mmHg) Used ambulatory oxygen < 2 hrs/day

Danish study on ambulatory oxygen combined with rehab. Inclusio criteria: Desat. >4% and less than <90% during

endurance shuttle walk test ESWT (85% of max.)Interested in using ambulatory oxygen (Freestyle)

Exclusion: COT Outcomes:

ESWT (pre- and post-rehab, 3, and 6 months)SGRQ, exacerbations, hospitalisation, mortality, and usage of oxygen.

26 patients randomised. Planned 110 pts. Only 40% of eligible pts wanted to participate.

International criteria for COT

PaO2 <7.3 kPa (Sat. 88%) (7.3-8.0: EVF>55% or cor pulmonale)

Post-PaO2 >8.6 kPa Stabile and optimal treatedStabile and optimal treated Non-smokers Used >15 hours daily Follow-up after 3 months and then every

6 months.

Start of HOT right after hospitalisation while patients are clinical unstable

Country Frequency Nationale Guidelines

80% Yes

28% Yes, if PO2<6.7 kPa

? Only stabile?

>4 weeks after hosp.

? Yes

Responsible for the treatment

Country Only pulm. physicians

Pulm. Phys. & Intern med.

Also GPs

Denmark X

Sweden X

Norway X

UK Specialist teams

Yes, but checked by specialist

International criteria for COT

PaO2 <7.3 kPa (Sat. 88%) (7.3-8.0: EVF>55% or cor pulmonale)

Post-PaO2 >8.6 kPa Stabile and optimal treated Non-smokers Used >15 hours daily Follow-up after 3 months and then every Follow-up after 3 months and then every

6 months. 6 months.

Follow-up in different countries

Country Adherence rate

Guidelines

Denmark1 60% 3 wks apart then every ½yr

UK2 61% The same

Norway ? 3 wks then every 3 months

Sweden3 39% 2 wks then every 6 months

1) Ringbaek et al. Respir Med 2006

2) Walshaw MJ et al. BMJ 1988

3) Utsättningsförsök hos KOL-pts startet ved forsämring

Home visits by a respiratory nurse?

Country Available?

Norway Yes

Denmark Most places with pulm. physicians

Sweden Recommended

UK Recommended and available many places

International criteria for COT

PaO2 <7.3 kPa (Sat. 88%) (7.3-8.0: EVF>55% or cor pulmonale)

Post-PaO2 >8.6 kPa Stabile and optimal treated Non-smokersNon-smokers Used >15 hours daily Follow-up after 3 months and then every

6 months.

Smoking and COT

Effect? Probably 15-24 hrs/day? Not possible for heavy

smokers Safe? Not everybody Ethical aspects? Seretide to smokers?

Effect of oxygen and CO on 12-minute walking distance

Calverley PMA, BMJ 1981

580

600

620

640

660

680

700

720

740

760

Air Oxygen Air+CO Oxygen+CO

12-MWD

meter p<0.01 p<0.01 p<0.01

15 COPD; FEV1=0.56 L; PO2: 5.2-7.7 kPa

Tobacco and COTin different countries

Country Prev. Guidelines

Denmark 21% Consider if PO2<6.7 kPa and max. 3 cig./day

Sweden 1.1% No

The Netherlands 26% No

Australia 14% No

UK 26% No

Norway ? No

International criteria for COT

PPaaOO22 <7.3 kPa (Sat. 88%) <7.3 kPa (Sat. 88%) (7.3-8.0: EVF>55% or cor pulmonale) (7.3-8.0: EVF>55% or cor pulmonale)

Post-PaO2 >8.6 kPa Stabile and optimal treated Non-smokers Used >15 hours daily Follow-up after 3 months and then every

6 months.

Adhere to the hypoxaemic criteria

Country Adherence rate

Denmark 60-70%

France 55-80%

UK 60%

Norway1 2002

2004

2005

44% of 25 pts

66% of 32 pts

35% of 48%

Sweden (2006) 81%2

1) Glittreklinikken; PO2 <7.3 kPa2) ”Bortfall”

International criteria for COT

PaO2 <7.3 kPa (Sat. 88%) (7.3-8.0: EVF>55% or cor pulmonale)

Post-PaO2 >8.6 kPa Stabile and optimal treated Non-smokers Used >15 hours dailyUsed >15 hours daily Follow-up after 3 months and then every

6 months.

Use/prescribed oxygen 16-24 hours daily

Country Adherence rate

Denmark 60/82%

UK 60%

Norway

Sweden (2006) 97%

Prevalence and Incidence of Home Oxygen

Therapy in Denmark 1994-2006

0

10

20

30

40

50

60

70

80

pe

r 1

00

.00

0

31.10.94 31.12.95 31.12.96 31.12.98 31.12.00 31.12.02 31.12.04 31.12.06

Prevalence

Not known

Others

Cancer

COPD

0

10

20

30

40

50

60

70

80

per

100

.000

1995 1996 1998 2000 2002 2004 2006

Incidence

Not known

Others

Cancer

COPD

Prevalence of HOT in various countries (per 100.000)

0102030405060708090

100

1987 1993 2006

DK

SE

F

N

Prevalence of HOT in various countries (per 100.000)

0

50

100

150

200

250

1987 1993 2006

DK

SE

F

N

US

Prescription of HOT in Denmark 1995 to 2006

0

10

20

30

40

50

60

70

80

90

1995 2002 2006

>15 hrsConc.LiquidMobile

%

Characteristics of patients on HOT in Denmark 1995 to 2006

0

10

20

30

40

50

60

70

´95 ´98 ´02 ´06

mean age%Females

Prescription of HOT in Danish COPD patients 1994 and 2000

0102030405060708090

100

1994 2000

>15 hrs

>1½ L/min

Konc/Flyd

Mobil

Oxygen devices in different countries

Country Concentrator Liquid Mobile unite

Denmark 72 11 58

Sweden 69%

Norway 60% 40%

UK <10 <50%

Survival rates of new COPD patients on COT from Denmark compared to patients from other countries

0

10

20

30

40

50

60

70

80

90

100

0 3 6 9 12 15 18 21 24 27 30 33 36 39

Months

Cu

mu

lativ

e s

urv

iva

l pro

po

rtio

n (

%)

%)

Denmark (n=5659)

Sweden (n=403)

Belgium (n=270)

France (n=252)

Australia (n=505)

NOTT, COT (n=101)

Japan (n=4552)

Bivirkninger/gener: 80-90% har gener, bl.a.:

begrænset livsførelse irritation ved næsen

udseende (når ude) Støj fra iltkoncentrator

Udendørs

65%

Ikke udendørs

35%

Mobil ilt (38%) 48% 21%

Anvendt timer/dag 1,32 1,13

27% anvendte ikke ilten Ringbæk; Respir Med 1999

Konklusion

Veldokumenteret effekt ved kronisk hypoxæmi

De fleste patienter starter efter indl. Kvaliteten af behandling er dårlig Mobil ilt ikke tilstrækkelig “mobil” Lille subgruppe har effekt af ilt ved

anstrengelse.

Iltudstyr

Koncentrator Komprimeret gas

(stationær & mobil) Flydende ilt

(stationær & mobil) Iltbesparende

device

IltsystemerFordele Ulemper

Konc. Ikke dgl. lev. Ditto“Flytbar” Larmer“Billig” StrømsvigtIngen explosion Problem m. flowFylde små flasker

Stålcyl.OK m. flow “Dyr”(store) Ingen larm Explosionsfare

Uafh. Af strøm Tung & klodsetDagl. leverance Ditto

IltsystemerFordele Ulemper

Flydende Fylder selv Problem m. trapper den mobile enhed Risiko for forfrysning Ikke behov for el UdslipHandy “Dyrt”Ingen larmIngen eksplosionHøjt flow er OK

Stålcyl.OK m. flow Relative tunge

(små) Ingen udslip EksplosionsfareMere udbredt

Effekt af iltbehandling

vejrtræningsarbejdevejrtræningsarbejde åndenødåndenød fysisk formåenfysisk formåen hæmodynamik hæmodynamik PAPPAP Htc.: 4-8%Htc.: 4-8% FEVFEV11: uændret: uændret

POPO22:: nyrefunktion (nyrefunktion (ødem)ødem)

trættræt søvnsøvn tænker klart (IQ)tænker klart (IQ) QoLQoL overlevelse: overlevelse: 2 2 4 år 4 år indlæggelse: 25%indlæggelse: 25%

Effekt af iltbehandling

vejrtræningsarbejde hæmodynamik PAP Htc.: 4-8% FEV1: uændret

PO2? nyrefunktion (ødem) åndenød fysisk formåen

træt søvn tænker klart (IQ) QoL overlevelse: 2 4 år indlæggelse: 25%

Bivirkninger/gener

80-90% har gener, bl.a.: begrænset livsførelse irritation ved næsen besværet spisning udseende (når ude)

Praktiske forhold ved LTOT

Hvordan ordineres LTOT? Fugtet luft? Pulssaturation versus a-punktur? Rejser inden- og udenlands?

Start LTOT

Ca. 80% starter LTOT efter indl. 30-50% har “normaliseret” PO2 efter 3 mdr. Information Oxygen-system(er) herunder bærbar ilt

Kontrol

Sat. (-OSat. (-O22) (hvis >88%, da a-punktur)) (hvis >88%, da a-punktur) Bestemme ilt-flowBestemme ilt-flow Sikre ikke-ryger statusSikre ikke-ryger status Sikre kompliance (15-24 timer)Sikre kompliance (15-24 timer) Behov for oxygen-systemerBehov for oxygen-systemer Evt. hjemme-visitEvt. hjemme-visit

Kvaliteten af behandlingen (KOL)

Ca. 20% ryger (måske flere) Ca. 50% har ikke iltmangel konstant Ca. 60% ses ambulant

0

10

20

30

40

50

60

70

80

90

100

%

Oxygenconcentrator orliquid oxygen

15-24 hrs/day

Mobile oxygen

Conclusion (1)

incidence and prevalence of COPD

most patients started after hospitalisation Prescribed 15-24 hrs/day - OK Only about 50% are followed up documented hypoxaemia survival compared to other countries

Conclusion (2)

delivered mobile oxygen Limited use of mobile oxygen. total use Liquid oxygen, but not cyl., time outside home Ambulatory oxygen: +short-term effect but

no/limited long-term effect Complaints from LTOT are common – especially

restricted autonomy and noise from the conc.

Tak for opmærksomheden

Økonomi

10-15.000 kr. årligt per pt. Ca. 3.600 patienter: ca. 50 mill. kr./år

Økonomi

Ca.10.000 kr. årligt per pt. Ca. 4.000 patienter: ca. 40 mill. kr./år Ca. 3.500 starter hvert år.

Effekt af iltterapi på QoL

CRQ (MCID) Oxygen-air P-value

Dyspnoe (3) 2,0 0,02

Fatigue (2) 1,8 0,02

Emotionel function (3) 3,3 0,006

Mastery (3) 1,8 0,008

Total (10) 8,8 0,002

Hypoxaemia status* in COPD. Data from the central part of Copenhagen

Nov. 1994 31.12.2000

N=145 N=214

83%

15%2%

72%

16%

12%

Hypoxaemic

Normoxaemic

Missing

P=0.018*) PO2 <7.3 kPa or 7.3-8.0 kPa + clinical signs of chronic hypoxaemia

All Danes: 57.5%

Adherence to guidelines

0

10

20

30

40

50

60

70

80

Hypox. Nosmok.

All

II (n=1354)

V-VII(n=822)

%

Follow-up and ”Sufficient Follow-up”

0

10

20

30

40

50

60

Follow-up Sufficient follow-up (n=722)

III 0-10 months(n=890)

V 1-6 months(n=533)

%

Conclusion (2)

delivered mobile oxygen Limited use of mobile oxygen. total use Ambulatory oxygen: +short-term effect but

no/limited long-term effect Complaints from LTOT are common –

especially restricted autonomy and noise from the conc.

Iltsystemer – fordele & ulemper

Forbedring af kvaliteten

Bedre iltudstyr Uddannelse af personale Information (mundtlig & skriftlig) til pat. Reglmæssig kontrol

(læge, sygepl., iltleverandør)

Effekt på QoL og 6-min. gangtest

Effects of Nocturnal Oxygen Therapy

63 COPD; FEV1=50%, PO2=76.5 mmHg, PCO2=39 mmHg

37 NOD 26 Controls

6 MWD: equalDesat: equal

SGRQ: equal

Wakabayashi P3355 ERS 2008