Oxygen saturation target ranges and alarm settings for very - - PowerPoint PPT Presentation

Oxygen saturation target ranges and alarm settings for very immature infants

Barbara Schmidt, MD, MSc, CM

Outline

• Design and main results of the Canadian

Oxygen Trial (COT)

• IPD Meta-analysis of COT, SUPPORT

and the 3 BOOST trials

• Saturation target ranges vs alarms
• Which target ranges and alarms are right

for your patients?

Barbara Schmidt, Robin Whyte, Elizabeth Asztalos, Diane Moddemann, Christian Poets, Yacov Rabi, Alfonso Solimano, Robin Roberts and The COT Investigators

Main COT Study Question

P I C O T In infants born at 23 0/7 to 27 6/7 wk, does a target saturation of 85-89% compared with 91-95% increase or decrease the risk of death

• r neurosensory disability

at a corrected age of 18 months?

Target range for displayed saturations

• n off-set pulse oximeters: 88-92%

Low target range for true saturations: 85-89% High target range for true saturations: 91-95%

Death or Disability at 18 Months

85-89% 91-95%

283 of 569 49.7%

OR = 1.08 95% CI 0.85-1.37 p = .52

298 of 578 51.6%

Components of Primary Outcome

85-89% 91-95% OR (95%CI)

Death 16.6% 15.3% 1.1 (0.8-1.5) GMFCS ≥2 6.1% 6.4% 1.0 (0.6-1.7)

Bayley III < 85

40% 40% 1.0 (0.8-1.3) Deafness 3.7% 2.5% 1.5 (0.7-3.2) Blindness 1.0% 0.6% 1.7 (0.4-7.1)

Secondary Outcomes

85-89% 91-95% P-value

Severe ROP 12.8% 13.1% .80 NEC 12.3% 9.3% .10

Targeting lower saturations reduced the PMA at last use of oxygen therapy by 0.8 weeks; 95% CI -1.5 to -0.1; P=.03

COT Conclusions

Targeting oxygen saturations of 85-89% as compared with 91-95% had no significant effect on rates of

• death or disability at 18 months
• death before 18 months
• necrotizing enterocolitis
• severe retinopathy of prematurity

Outline

• Design and main results of the

Canadian Oxygen Trial (COT)

• Meta-analysis of COT, SUPPORT and

the 3 BOOST trials

• Saturation target ranges vs alarms
• Which target ranges and alarms are

right for your patients?

Effects of Targeting Lower Saturations Trial

Death before Follow-up Severe ROP

SUPPORT



↓↓

BOOST NZ No Diff No Diff BOOST AU No Diff No Diff BOOST UK No Diff No Diff COT No Diff No Diff

JAMA 2018; 319:2190-2201

Main NeOProM Results

SpO2 85-89% SpO2 91-95% Adjusted RR (95%CI) P- value Risk Difference Primary

• utcome

53.5% 51.6% 1.04 (0.98, 1.09) 0.21 Major disability 40.5% 40.5% 1.00 (0.93, 1.08) 0.97 Death 19.9% 17.1% 1.17 (1.04, 1.31) 0.01 2.8% Severe NEC 9.2% 6.9% 1.33 (1.10, 1.61) 0.003 2.3% ROP treatment 10.9% 14.9% 0.74 (0.63, 0.86) <0.001 4.0%

This IPD meta-analysis is an important achievement but has delivered no surprises!

AAP Conclusion

Recent RCTs suggest that a targeted

• xygen saturation range of 90% to

95% may be safer than 85% to 89%, at least for some infants. However, the ideal oxygen saturation range for extremely low birth weight infants remains unknown.

“We detected 40 different SpO2 ranges, and even the most frequently reported range (i.e., 90–95%) was used in only 28% of the 193 respondent NICUs.”

Survey conducted Nov 2015 to Feb 2016

NeOProM Intervention

Alarm settings? Compliance with alarm settings? Impact of reversal from off-set to true saturations? Response to alarms? Duration of targeting? Transfusion policies?

Outline

• Design and main results of the

Canadian Oxygen Trial (COT)

• Meta-analysis of COT, SUPPORT and

the 3 BOOST trials

• Saturation target ranges vs alarms
• Which target ranges and alarms are

right for your patients?

Target ranges are not alarm settings

Protocol-prescribed alarm settings after conversion to true SpO2

Goal of Oxygen SaturationTargeting

“Providers need to understand that

cumulative oxygen saturations

• ver time represent a bell shaped

curve, and the role of the health care team is to minimize the tails in both directions”.

Greenspan and Goldsmith, Pediatrics 2006; 118:1741

JAMA 2015;314:595-603

Intermittent Hypoxemia and Late Death or Disability

JAMA 2015;314:595-603

Intermittent Hypoxemia and Motor Impairment

AAP Conclusion

Alarm limits are used to avoid potentially harmful extremes of hyperoxemia or hypoxemia. Given the limitations of pulse oximetry and the uncertainty that remains regarding the ideal oxygen saturation target range for infants of extremely low birth weight, these alarm limits could be fairly wide.

AAP Conclusion

Regardless of the chosen target, an upper alarm limit approximately 95% while the infant remains on supplemental oxygen is reasonable.

AAP Conclusion

A lower alarm limit will generally need to extend somewhat below the lower target, as it must take into account practical and clinical considerations, as well as the steepness of the

• xygen saturation curve at lower

saturations.

Outline

• Design and main results of the

Canadian Oxygen Trial (COT)

• Meta-analysis of COT, SUPPORT and

the 3 BOOST trials

• Saturation target ranges vs alarms
• Which target ranges and alarms are

right for your patients?

Outcome Rates Differ Between Trials

Trial

Death before Follow up Severe ROP SUPPORT 20.1% 13.4% BOOST NZ 15.3% 7.5% BOOST AU 16.7% 7.7% BOOST UK 22.8% 19.2% COT 15.9% 12.9%

NeOProM

Outcome NNT NNH Mortality 36 Severe NEC 44 Treated ROP 25

Number needed to treat (NNT) or harm (NNH) with higher saturation target range:

Absolute effects of higher targeting will depend on our patients’ baseline risks Example: Mortality

Baseline Risk Absolute Risk Reduction NN Treat 20% 2.8% 36 10% 1.4% 71 5% 0.7% 143

An example from a Canadian NICU

Outcome Rate NNT NNH Mortality 9% 77 Surgical NEC 4% 100 Severe ROP 13% 21

Our oximeter alarms have been set at 85% and 95% for many years. Why should we change them?