ICU-ROX Paul Young Intensive Care Unit Randomised trial comparing two approaches to Oxygen therapy
ICU-ROX
Paul Young
Intensive Care Unit Randomised trial comparing two approaches
to Oxygen therapy
Paul YoungRichard BeasleyRinaldo BellomoAdam Deane
Glenn EastwoodSimon FinferRoss Freebairn
Ed LittonColin McArthurShay McGuinessDiane MackleRakshit PanwarMark Weatherall
Managem
ent Com
mittee
O2 % The great oxygenation
event
now2.4 billion years ago
21
0
the history of O2
Background
Humans are adapted to an FiO2 of 0.21 & and a PaO2 of 80-
100mmHg
Background
Background
oxygen
glucose
Energy
CO2
H2O
Sick ICU patients get ventilated; all
ventilated patients receive oxygen
Background
Some oxygen questions.
1.SpO2 targets2.PaO2 targets3.Normobarichyperoxia
4.Permissive hypoxaemia
5.Is an (avoidable) FiO2 of >0.21 bad?
6.Is an arterial PaO2of >normal bad?
Background
Hypoxaemia is bad & hyperoxaemia is bad & exposure to higher than necessary FiO2 is bad
Hypothesis
1500‐participant RCT
Design
INTERVENTION
1. Strict avoidance of hyperoxia
2. Avoidance of higher than necessary FiO2
CONTROL
Standard carevs.
LOWER LIMIT OF SPO2 OF 91% (OR LOWER IF CLINICIAN PREFERS) IN BOTH GROUPS
Inclusion criteria
• ≥18 years• Invasive
ventilation in ICU• Expected to
remain ventilated the day after tomorrow
Participants
Exclusion criteria
• > 2 hours of invasive ventilation in ICU
• > 2 hours of non‐invasive ventilation in ICU
• In ICU >24 hours• Hyperoxia indicated• Avoidance of hyperoxia
indicated• Pregnancy• Admitted following drug
overdose• Death expected
Participants
CONSERVATIVE OXYGEN THERAPY
Intervention
Key features
• Compulsory use of upper limit SpO2 alarms
• Algorithm to ensure the lowest FiO2 possible
• No difference in the lower limit of acceptable SpO2compared to standard care
Intervention
SpO2
>90%
• Do not use upper limit SpO2 alarms.
SpO2
90% or less
•If the SpO2 falls to 90% or less increase FiO2 and investigate as necessary in accordance with usual practice
STANDARD CARE
Control A
rm
Key features• Use of upper limit
alarms for SpO2prohibited
Control arm
Primary outcome
• 90 day all cause mortality
End points
Secondary end points (180 days)
• All cause mortality• Duration of survival• Quality of life • Cognitive function
End points
Quality of life assessments
• EuroQol5d• Proportion of patients
in paid employment at baseline who are no longer employed at day 180
• GOSE (for acute brain injury patients)
End points
Cognitive function
• Telephone interview for cognitive status (TICS)
End points
Process of care
measures
• Daily FiO2 (mean, highest, lowest)
• Daily PEEP (mean, highest, lowest)
• Daily mean airway pressure (mean, highest, lowest)
• Ventilation mode• Ventilator Free Days• Time to ICU discharge• Time to Hospital discharge• Proportion of patients
requiring RRT• Proportion of patients
requiring tracheostomy
End points
Physiological outcomes
• Daily PaO2 (mean, highest, lowest)
• Delta creatinine
End points
Physiological outcomes and process
of care measures
• Detailed data for 10 days• A bit of data until 28 days
End points
1500 participants
• Baseline mortality rate 25%• 90% power to detect a 7%
difference in mortality
Sample size
Clinical audit evaluating
O2 therapy in mechanically ventilated ICU patients
• Before ICU‐ROX• After ICU‐ROX• SIMPLE• Ed Litton is leading this
aspect of the programme
ICU
-RO
X TRIPS
100 participants
• Only report data on oxygen and ventilation parameters
• Collect data for all study end points
Pilot run-in
HRC application this year
• Will submit for CTG endorsement today
• Current protocol has ethics approval in NZ & has been submitted for approval in Aus
• Pilot starting soon• Draft CRF available• Can participate now &
get paid later• Contact me
Status
@DogICUma