DISCLOSURE...SPO 2 IN ICU BY TREATMENT GROUP. 0 10 20 30 40 50 60 70 80 90 100 Usual Oxygen...
42
Transcript of DISCLOSURE...SPO 2 IN ICU BY TREATMENT GROUP. 0 10 20 30 40 50 60 70 80 90 100 Usual Oxygen...
DISCLOSURE
CONSERVATIVE
oxygen therapy vs.
USUAL oxygen
therapy in
mechanically ventilated adults
CONSERVATIVE
oxygen therapy would
↑ DAYS ALIVE & FREE
from INVASIVE
MECHANICAL VENTILATION to day 28
HYP
OTH
ESIS
o ≥18 years
o Mechanically
ventilated &
expected to be
ventilated beyond tomorrow
INC
LUSI
ON
CR
ITER
IA
TWO
HOUR window
o From SEPT 2015 through MAY 2018, we enrolled 1000 patients in 21 ADULT MEDICAL-SURGICAL ICUS in Australia and New Zealand
SET
TIN
G
Conservative O2
Usual O2
PA
RTI
CIP
AN
T FLO
WMet inclusion
criteria(n=3366)
Met an exclusion (n=848)o Death is deemed to be inevitable (n=254)
o Enrolment not considered in the patient’s best interests
(n=185)
o Admitted following a drug overdose (n=134)
o Avoidance of hyperoxia is clinically indicated (n=81)
o Guillain-Barré syndrome, cervical cord injury above C5,
muscular dystrophy, or motor neurone disease (n=70)
o Patients with a life expectancy <90 days (n=51)
o Hyperoxia is clinically indicated (n=45)
o Pregnancy (n=7)
o Previously enrolled (n=6)
o Long-term dependence on invasive ventilation prior to
this acute illness (n=5)
o Enrolled in another trial of targeted oxygen therapy
(n=3)
o Other (n=7)
Did not
consent(n=8)
Eligible but
missed (n=1510)
Randomised(n=1000)
PA
RTI
CIP
AN
T FLO
W
Randomised to usual oxygen
(n=501)• Received allocated
intervention (n=494)
• Did not receive allocation
intervention with reasons (n=7):
•Consent to administer
treatment withdrawn (n=7)
•Patient was ineligible (n=0)
•Patient died prior to
receiving treatment (n=0)
PA
RTI
CIP
AN
T FLO
W
Randomised to conservative
oxygen (n=499)• Received allocated
intervention (n=492)
• Did not receive allocation
intervention with reasons (n=7):
•Consent to administer
treatment withdrawn (n=7)
•Patient was ineligible (n=0)
•Patient died prior to
receiving treatment (n=0)
Lost to follow-up (n=20)• Consent withdrawn(n=20)
• Unable to locate patient (n=0)
PA
RTI
CIP
AN
T FLO
W
Lost to follow-up(n=15)• Consent withdrawn(n=15)
• Unable to locate patient(n=0)
Analysed (n=481)Analysed (n=484)
INTE
RV
ENTI
ON
Conservative oxygen therapy
was designed to both MINIMISE
exposure to HIGH SPO2 and to
increase exposure to LOWER
INSPIRED O2 CONCENTRATIONS
CO
NTR
OL
o 58 years; 63% male
o 92% were emergency admissions of which ¼ were
from the operating theatre
o Median time from ICU admission to randomisation
was 1½ hours
o Mean APACHE-II score was 23.4
o 40% of patients had acute brain pathologies
including TBI, ischaemic stroke, SAH, and
suspected HIE
o There were 166 patients with suspected HIE
PATI
ENT
CH
AR
AC
TER
ISTI
CS
SEPA
RA
TIO
N
0 10 20 30 40 50 60 70 80 90 100
Usual Oxygen
Conservative Oxygen
Percentage of hours in given SpO2 range
SpO2 <88% SpO2 <91% SpO2 91-96% SpO2 >96%
SPO2 IN ICU BY TREATMENT GROUP
0 10 20 30 40 50 60 70 80 90 100
Usual Oxygen
Conservative Oxygen
Percentage of hours on given FiO2
FiO2 =0.21 FiO2 >0.21
SEPA
RA
TIO
NFiO2 WHILE INVASIVELY VENTILATED BY TREATMENT GROUP
Innovative therapies
2.1 days ↓
to
1.6 days ↑Ventilator free days; median (IQR):
conservative oxygen: 21.3 [0.0-26.3] vs. standard oxygen: 22.1 [0.0-26.2]; P=0.80
PR
IMA
RY
OU
TCO
ME
Conservative Oxygen therapy
relative risk, 1.03; 95% CI, 0.87 to 1.23
Usual Oxygen therapy
SEC
ON
DA
RY
OU
TCO
MES
BLINDED centralised
assessment of
EMPLOYMENT status,
QUALITY OF LIFE, & FUNCTION at day 180
SEC
ON
DA
RY
OU
TCO
MES
QUALITY OF LIFE
was assessed using EQ5D5L
SEC
ON
DA
RY
OU
TCO
MES
=170
MOBILITY at day 180
Usual oxygen therapy (n=481)
=68 =164 =64
Conservative oxygen therapy (n=484)
3.7%(n=9)
5.9%(n=15)
2.8%(n=7)
8.7%(n=22)
23.2%(n=57)
14.6%(n=37)
43.9%(n=108)
47.8%(n=121)
22.9%(n=58)
26.4%(n=65)
UNABLE TO
SEVERE
MODERATE
SLIGHT
NO PROBS
=170
SELF-CARE at day 180
Usual oxygen therapy (n=481)
=68 =164 =64
Conservative oxygen therapy (n=484)
4.1%(n=10)
4.7%(n=12)
0.2%(n=2)
4.0%(n=10)
10.2%(n=25)
2.8%(n=7)
10.2%(n=25)
72.7%(n=184)
74.8%(n=184)
UNABLE TO
SEVERE
MODERATE
SLIGHT
NO PROBS
15.8%(n=40)
USUAL ACTIVITIES at day 180
PAIN & DISCOMFORT at day 180
ANXIETY & DEPRESSION at day 180
COGNITION was
assessed using the
TELEPHONE INTERVIEW
FOR COGNITIVE STATUS (TICS)
SEC
ON
DA
RY
OU
TCO
MES
=170
COGNITIVE FUNCTION at day 180
Usual oxygen therapy (n=481)
=111 =164 =111
Conservative oxygen therapy (n=484)
2.5%(n=5)
2.9%(n=6)
8.9%(n=18)
10.7%(n=22)
49.3%(n=100)
50.5%(n=104)
39.4%(n=80)
35.9%(n=74)
SEVERE
MILD
AMBIGUOUS
NON-
IMPAIRED
↓28 hoursto an
↑11 hours
PR
OC
ESS
OF
CA
RE
MEA
SUR
ES
↓2½ daysto an
↑1½ days
PR
OC
ESS
OF
CA
RE
MEA
SUR
ES
RRT in ICU, tracheostomy in ICU, use
of ECMO, use of neuromuscular
blockade, use of prone positioning,
use of prostaglandins, delta
creatinine, number of ABGs,
number of units of blood transfused
PR
OC
ESS
OF
CA
RE
MEA
SUR
ES
SUBGROUP ANALYSES
MEDIAN ALIVE VENTILATOR-FREE DAYS [IQR]
CONSERVATIVE
OXYGEN THERAPY
(n=485)
USUAL OXYGEN
THERAPY (n=485)
DIFFERENCE IN
MEDIANS
(95% CI)
INTERACTION
P VALUE
SURGERYYES 24.0 [0.7 to 26.5] 23.7 [12.3 to 26.4] 0.2 [-3.0 to 3.4]
P=0.70NO 20.1 [0.0 to 26.1] 21.0 [0.0 to 26.1] -0.9 [-5.7 to 3.9]
PF RATIO <300mmHg
YES 19.6 [0.0 to 26.3] 21.4 [0.0 to 26.0] -1.8 [-6.0 to 2.5]P=0.88
NO 22.4 [0.0 to 26.3] 23.8 [12.3 to 26.4] -1.4 [-4.5 to 1.8]
BRAINYES 20.5 [0.0 to 26] 18.9 [0.0 to 26] 1.2 [-7.3 to 9.6]
P=0.66NO 22.9 [0.0 to 26.5] 23.1 [0.7 to 26.3] -0.3 [-3.1to 2.6]
HIEYES 21.1 [0.0 to 26.1] 0.0 [0.0 to 26] 21.1 [10.4 to 28.0]
P=0.007NO 22.6 [0.0 to 26.5] 23.1 [0.7 to 26.3] -1.4 [-3.6 to 0.8]
Post hoc analyses of the HYPOXIC ISCHAEMIC
ENCEPHALOPATHY subgroup
Conservative Oxygen therapy
relative risk, 0.73; 95% CI, 0.54 to 0.99
Usual Oxygen therapy
43% died 59% died
HR; 0.67; 95% CI, 0.44 to 1.06
GOS-E RESULTS AT 6 MONTHS
(HYPOXIC ISCHAEMIC ENCEPHALOPATHY PATIENTS ONLY)
0 10 20 30 40 50 60 70 80 90 100
standard oxygen
conservative oxygen
Percent
Death Vegetative Lower severe disability Upper severe disability
Lower moderate disability Upper moderate disability Lower good recovery Upper good recovery
Innovative therapies
Conservative oxygen therapy
DID NOT INCREASE VENTILATOR-FREE DAYS
compared with usual oxygen therapy
CO
NC
LUSI
ON
Diane Mackle, Rinaldo Bellomo,
Michael Bailey, Richard Beasley,
Victoria Bennett, Adam Deane, Glenn
Eastwood, Simon Finfer, Ross Freebairn,
Natalie Linke, Edward Litton, Colin
McArthur, Shay McGuinness, Rakshit Panwar, Paul Young.
