ltot gøteborg 2008
TRANSCRIPT
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Unpublished data.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