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ICU-ROX Paul Young Intensive Care Unit Randomised trial comparing two approaches to Oxygen therapy
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ICU-ROX - · PDF fileICU-ROX Paul Young Intensive Care Unit ... SpO 2 >90% •Do not ... ICU patients • Before ICU‐ROX • After ICU‐ROX • SIMPLE • Ed Litton is

Feb 06, 2018

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Page 1: ICU-ROX -  · PDF fileICU-ROX Paul Young Intensive Care Unit ... SpO 2 >90% •Do not ... ICU patients • Before ICU‐ROX • After ICU‐ROX • SIMPLE • Ed Litton is

ICU-ROX

Paul Young

Intensive Care Unit Randomised trial comparing two approaches

to Oxygen therapy

Page 2: ICU-ROX -  · PDF fileICU-ROX Paul Young Intensive Care Unit ... SpO 2 >90% •Do not ... ICU patients • Before ICU‐ROX • After ICU‐ROX • SIMPLE • Ed Litton is

Paul YoungRichard BeasleyRinaldo BellomoAdam Deane

Glenn EastwoodSimon FinferRoss Freebairn

Ed LittonColin McArthurShay McGuinessDiane MackleRakshit PanwarMark Weatherall

Managem

ent Com

mittee

Page 3: ICU-ROX -  · PDF fileICU-ROX Paul Young Intensive Care Unit ... SpO 2 >90% •Do not ... ICU patients • Before ICU‐ROX • After ICU‐ROX • SIMPLE • Ed Litton is

O2 % The great oxygenation

event

now2.4 billion years ago

21

0

the history of O2

Background

Page 4: ICU-ROX -  · PDF fileICU-ROX Paul Young Intensive Care Unit ... SpO 2 >90% •Do not ... ICU patients • Before ICU‐ROX • After ICU‐ROX • SIMPLE • Ed Litton is

Humans are adapted to an FiO2 of 0.21 & and a PaO2 of 80-

100mmHg

Background

Page 5: ICU-ROX -  · PDF fileICU-ROX Paul Young Intensive Care Unit ... SpO 2 >90% •Do not ... ICU patients • Before ICU‐ROX • After ICU‐ROX • SIMPLE • Ed Litton is

Background

oxygen

glucose

Energy

CO2

H2O

Page 6: ICU-ROX -  · PDF fileICU-ROX Paul Young Intensive Care Unit ... SpO 2 >90% •Do not ... ICU patients • Before ICU‐ROX • After ICU‐ROX • SIMPLE • Ed Litton is

Sick ICU patients get ventilated; all

ventilated patients receive oxygen

Background

Page 7: ICU-ROX -  · PDF fileICU-ROX Paul Young Intensive Care Unit ... SpO 2 >90% •Do not ... ICU patients • Before ICU‐ROX • After ICU‐ROX • SIMPLE • Ed Litton is

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

Page 8: ICU-ROX -  · PDF fileICU-ROX Paul Young Intensive Care Unit ... SpO 2 >90% •Do not ... ICU patients • Before ICU‐ROX • After ICU‐ROX • SIMPLE • Ed Litton is

Hypoxaemia is bad & hyperoxaemia is bad & exposure to higher than necessary FiO2 is bad

Hypothesis

Page 9: ICU-ROX -  · PDF fileICU-ROX Paul Young Intensive Care Unit ... SpO 2 >90% •Do not ... ICU patients • Before ICU‐ROX • After ICU‐ROX • SIMPLE • Ed Litton is

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 

Page 10: ICU-ROX -  · PDF fileICU-ROX Paul Young Intensive Care Unit ... SpO 2 >90% •Do not ... ICU patients • Before ICU‐ROX • After ICU‐ROX • SIMPLE • Ed Litton is

Inclusion criteria

• ≥18 years• Invasive 

ventilation in ICU• Expected to 

remain ventilated the day after tomorrow

Participants

Page 11: ICU-ROX -  · PDF fileICU-ROX Paul Young Intensive Care Unit ... SpO 2 >90% •Do not ... ICU patients • Before ICU‐ROX • After ICU‐ROX • SIMPLE • Ed Litton is

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

Page 12: ICU-ROX -  · PDF fileICU-ROX Paul Young Intensive Care Unit ... SpO 2 >90% •Do not ... ICU patients • Before ICU‐ROX • After ICU‐ROX • SIMPLE • Ed Litton is

CONSERVATIVE OXYGEN THERAPY

Intervention

Page 13: ICU-ROX -  · PDF fileICU-ROX Paul Young Intensive Care Unit ... SpO 2 >90% •Do not ... ICU patients • Before ICU‐ROX • After ICU‐ROX • SIMPLE • Ed Litton is

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

Page 14: ICU-ROX -  · PDF fileICU-ROX Paul Young Intensive Care Unit ... SpO 2 >90% •Do not ... ICU patients • Before ICU‐ROX • After ICU‐ROX • SIMPLE • Ed Litton is

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

Page 15: ICU-ROX -  · PDF fileICU-ROX Paul Young Intensive Care Unit ... SpO 2 >90% •Do not ... ICU patients • Before ICU‐ROX • After ICU‐ROX • SIMPLE • Ed Litton is

Key features• Use of upper limit 

alarms for SpO2prohibited

Control arm

Page 16: ICU-ROX -  · PDF fileICU-ROX Paul Young Intensive Care Unit ... SpO 2 >90% •Do not ... ICU patients • Before ICU‐ROX • After ICU‐ROX • SIMPLE • Ed Litton is

Primary outcome

• 90 day all cause mortality

End points

Page 17: ICU-ROX -  · PDF fileICU-ROX Paul Young Intensive Care Unit ... SpO 2 >90% •Do not ... ICU patients • Before ICU‐ROX • After ICU‐ROX • SIMPLE • Ed Litton is

Secondary end points (180 days)

• All cause mortality• Duration of survival• Quality of life • Cognitive function

End points

Page 18: ICU-ROX -  · PDF fileICU-ROX Paul Young Intensive Care Unit ... SpO 2 >90% •Do not ... ICU patients • Before ICU‐ROX • After ICU‐ROX • SIMPLE • Ed Litton is

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

Page 19: ICU-ROX -  · PDF fileICU-ROX Paul Young Intensive Care Unit ... SpO 2 >90% •Do not ... ICU patients • Before ICU‐ROX • After ICU‐ROX • SIMPLE • Ed Litton is

Cognitive function

• Telephone interview for cognitive status (TICS)

End points

Page 20: ICU-ROX -  · PDF fileICU-ROX Paul Young Intensive Care Unit ... SpO 2 >90% •Do not ... ICU patients • Before ICU‐ROX • After ICU‐ROX • SIMPLE • Ed Litton is

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

Page 21: ICU-ROX -  · PDF fileICU-ROX Paul Young Intensive Care Unit ... SpO 2 >90% •Do not ... ICU patients • Before ICU‐ROX • After ICU‐ROX • SIMPLE • Ed Litton is

Physiological outcomes

• Daily PaO2 (mean, highest, lowest)

• Delta creatinine

End points

Page 22: ICU-ROX -  · PDF fileICU-ROX Paul Young Intensive Care Unit ... SpO 2 >90% •Do not ... ICU patients • Before ICU‐ROX • After ICU‐ROX • SIMPLE • Ed Litton is

Physiological outcomes and process 

of care measures

• Detailed data for 10 days• A bit of data until 28 days

End points

Page 23: ICU-ROX -  · PDF fileICU-ROX Paul Young Intensive Care Unit ... SpO 2 >90% •Do not ... ICU patients • Before ICU‐ROX • After ICU‐ROX • SIMPLE • Ed Litton is

1500 participants

• Baseline mortality rate 25%• 90% power to detect a 7% 

difference in mortality

Sample size

Page 24: ICU-ROX -  · PDF fileICU-ROX Paul Young Intensive Care Unit ... SpO 2 >90% •Do not ... ICU patients • Before ICU‐ROX • After ICU‐ROX • SIMPLE • Ed Litton is

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

Page 25: ICU-ROX -  · PDF fileICU-ROX Paul Young Intensive Care Unit ... SpO 2 >90% •Do not ... ICU patients • Before ICU‐ROX • After ICU‐ROX • SIMPLE • Ed Litton is

100 participants

• Only report data on oxygen and ventilation parameters

• Collect data for all study end points

Pilot run-in

Page 26: ICU-ROX -  · PDF fileICU-ROX Paul Young Intensive Care Unit ... SpO 2 >90% •Do not ... ICU patients • Before ICU‐ROX • After ICU‐ROX • SIMPLE • Ed Litton is

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

Page 27: ICU-ROX -  · PDF fileICU-ROX Paul Young Intensive Care Unit ... SpO 2 >90% •Do not ... ICU patients • Before ICU‐ROX • After ICU‐ROX • SIMPLE • Ed Litton is

[email protected]

@DogICUma