FANNP 28TH NATIONAL NNP SYMPOSIUM: CLINICAL UPDATE AND REVIEW OCTOBER 17-21, 2017

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1 Pulse Oximetry in the Delivery Room: Principles and Practice GS2 3 Jonathan P. Mintzer, MD, FAAP Assistant Professor of Pediatrics Stony Brook Children s Hospital, Division of Neonatal-Perinatal Medicine, Stony Brook, NY The speaker has signed a disclosure statement indicating that he has no significant financial interest or relationship with the companies or the manufacturer(s) of any commercial product and/or service that will be discussed as part of this presentation. Session Summary The use of pulse oximetry monitoring in the delivery room setting will be discussed, ranging from its initial introduction into newborn resuscitation techniques progressing to updates regarding pulse oximetry use in the Neonatal Resuscitation Program paradigm. The rationale for initial fraction of inspired oxygen (FiO2) selection and titration methods will be explained. Studies will be presented on the importance of avoiding excessive oxygen exposure in the delivery room. Session Objectives Upon completion of this presentation, the participant will be able to: state the rationale for use of oxygen saturation monitoring in the delivery room; convey the expected range of observed oxygen saturations during neonatal transition; delineate outcomes associated with excessive oxygen exposure in the delivery room. References American Heart Association, American Academy of Pediatrics (2006) American Heart Association (AHA) guidelines for cardiopulmonary resuscitation (CPR) and emergency cardiovascular care (ECC) of pediatric and neonatal patients: Neonatal resuscitation guidelines. Pediatrics, 117(5), e Bookatz, G. B., et al. (2007). Effect of supplemental oxygen on reinitiation of breathing after neonatal resuscitation in rat pups. Pediatric Research, 61(6), Dawson J. A., et al.(2010). Defining the reference range for oxygen saturation for infants after birth. Pediatrics,125(6), e Dawson, J. A. & Morley, C. J. (2010). Monitoring oxygen saturation and heart rate in the early neonatal period. Seminars in Fetal & Neonatal Medicine,15(4), Escrig, E., et al. (2008). Achievement of targeted saturation values in extremely low gestational age neonates resuscitated with low or high oxygen concentrations: A prospective, randomized trial. Pediatrics, 121(5), Gandhi, B., Rich, W., & Finer, N. (2013). Achieving targeted pulse oximetry values in preterm infants in the delivery room. The Journal of Pediatrics, 163(2), Kapadia, V. S., et al. (2013). Resuscitation of preterm neonates with limited versus high oxygen strategy. Pediatrics, 132(6), e Lakshminrusimha, S., et al. (2007). Pulmonary hemodynamics in neonatal lambs resuscitated with 21%, 50%, and 100% oxygen. Pediatric Research, 62(3), Page 1 of 17

2 Markus, T., et al. (2007). Cerebral inflammatory response after fetal asphyxia and hyperoxic resuscitation in newborn sheep. Pediatric Research, 62(1), O Donnell, C. P. F., et al. (2005). Obtaining pulse oximetry data in neonates: A randomized crossover study of sensor application techniques. Archives of Disease in Childhood Fetal & Neonatal Edition, 90(1), F84-5. O Donnell, C. P. F., et al. (2007). Clinical assessment of infant colour at delivery. Archives of Disease in Childhood Fetal & Neonatal Edition, 92(6), F Patel, A., et al. (2009). Exposure to supplemental oxygen downregulates antioxidant enzymes and increases pulmonary arterial contractility in premature lambs. Neonatology, 96(3), Perlman, J. M, & Wyllie, J, et al. (2010). Part 11: Neonatal resuscitation: 2010 International Consensus on cardiopulmonary resuscitation and emergency cardiovascular care science with treatment recommendations. Circulation,122 [suppl 2], S Saugstad, O. D., et al. (2014). Systemic review and meta-analysis of optimal initial fraction of oxygen levels in the delivery room at 32 weeks. Acta Paediatrica, 103(7), Tataranno, M. L., et al. (2015). Resuscitating preterm infants with 100% oxygen is associated with higher oxidative stress than room air. Acta Paediatrica, 104(8), Vento, M., et al. (2008). Using intensive care technology in the delivery room: A new concept for the resuscitation of extremely preterm neonates. Pediatrics, 122(5), Vento, M., et al. (2009). Preterm resuscitation with low oxygen causes less oxidative stress, inflammation, and chronic lung disease. Pediatrics, 124(3), e Vento, M. & Saugstad, O. D. (2011). Oxygen supplementation in the delivery room: Updated information. The Journal of Pediatrics, 158 [2 suppl], e5-7. Wyllie, J. & Perlman, J. M., et al. (2015). Part 7: Neonatal resuscitation: 2015 International Consensus on cardiopulmonary resuscitation and emergency cardiovascular care science with treatment recommendations. Resuscitation, 95, e Page 2 of 17

OVERVIEW 1) Recommendations Targeted Oxygen Saturation Monitoring in the

Consensus o 2015 International Consensus 2) Studies o Oximeter usage o

Practitioners Clinical Update and Review Jonathan P.

American Heart Association, American Academy of Pediatrics, Pediatrics,

RECOMMENDATIONS Perlman JM & Wyllie J, et al.

Emergency Cardiovascular Care Science with Treatment Recommendations.

2010 INTERNATIONAL CONSENSUS Perlman JM & Wyllie J, et al.

3 OVERVIEW 1) Recommendations Targeted Oxygen Saturation Monitoring in the Delivery Room o 2005 American Heart Association o 2010 International Consensus o 2015 International Consensus 2) Studies o Oximeter usage o Normative data o Oxygen titration Florida Association for Neonatal Nurse Practitioners Clinical Update and Review Jonathan P. Mintzer, MD, FAAP 3) Conclusions October 17, 2017 RECOMMENDATIONS American Heart Association, American Academy of Pediatrics, Pediatrics, AHA RECOMMENDATIONS American Heart Association, American Academy of Pediatrics, Pediatrics, RECOMMENDATIONS Perlman JM & Wyllie J, et al International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations. Circulation, INTERNATIONAL CONSENSUS Perlman JM & Wyllie J, et al International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations. Circulation, Page 3 of 17

2015 INTERNATIONAL CONSENSUS 2015 INTERNATIONAL CONSENSUS Use of pulse oximetry now well established Start pulse oximetry Start pulse oximetry Wyllie J & Perlman

Resuscitation, 2015. O DONNELL, 2007 Subjective assessment of color Why Use Pulse Oximetry? Vs. Objective assessment of oxygenation O Donnell CPF, et al.

4 2010 INTERNATIONAL CONSENSUS Perlman JM & Wyllie J, et al International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations. Circulation, INTERNATIONAL CONSENSUS Perlman JM & Wyllie J, et al International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations. Circulation, INTERNATIONAL CONSENSUS 2015 INTERNATIONAL CONSENSUS Use of pulse oximetry now well established Start pulse oximetry Start pulse oximetry Wyllie J & Perlman JM, et al International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations. Resuscitation, O DONNELL, 2007 Subjective assessment of color Why Use Pulse Oximetry? Vs. Objective assessment of oxygenation O Donnell CPF, et al. Archives of Disease in Childhood Fetal & Neonatal Edition, Page 4 of 17

O DONNELL, 2007 O DONNELL, 2007 HD video analysis of 20 deliveries n=27; NICU personnel o Neonatologist (7), Fellow (5), Nurse (14), Clerk (1) Report of pink at beginning, became pink, or never pink

5 O DONNELL, 2007 O DONNELL, 2007 HD video analysis of 20 deliveries n=27; NICU personnel o Neonatologist (7), Fellow (5), Nurse (14), Clerk (1) Report of pink at beginning, became pink, or never pink Results compared to SpO 2 monitoring 1 neonate (5%) called pink by all participants; max SpO 2 87% O Donnell CPF, et al. Archives of Disease in Childhood Fetal & Neonatal Edition, O Donnell CPF, et al. Archives of Disease in Childhood Fetal & Neonatal Edition, O DONNELL, 2007 O DONNELL, 2007 Conclusion Color assessment alone is insufficient for assessing oxygenation status. O Donnell CPF, et al. Archives of Disease in Childhood Fetal & Neonatal Edition, O Donnell CPF, et al. Archives of Disease in Childhood Fetal & Neonatal Edition, OXIMETER PROBLEMS Difficulty with Pulse Oximeter Usage in Delivery Room? Failure to obtain/maintain signal Motion artifact Acrocyanosis Presence of vernix Cracked/wrinkled skin Low perfusion Tissue edema High ambient light Large infants Dawson JA & Morley CJ. Seminars in Fetal & Neonatal Medicine, Page 5 of 17

O DONNELL, 2005 O DONNELL, 2005 Probe placement study n=40; stable NICU babies Masimo Radical; preductal only 3 probe application techniques Outcome: time to data collection (displayed heart rate) O

6 O DONNELL, 2005 Obtaining a Pulse Oximetry Signal Does technique of probe placement affect time to first SpO 2 measure? O Donnell CPF, et al. Archives of Disease in Childhood Fetal & Neonatal Edition, O DONNELL, 2005 O DONNELL, 2005 Probe placement study n=40; stable NICU babies Masimo Radical; preductal only 3 probe application techniques Outcome: time to data collection (displayed heart rate) O Donnell CPF, et al. Archives of Disease in Childhood Fetal & Neonatal Edition, O Donnell CPF, et al. Archives of Disease in Childhood Fetal & Neonatal Edition, O DONNELL, 2005 O DONNELL, 2005 Probe placement techniques: 1) Sensor connected to cable, then infant 2) Sensor connected to cable, then investigator s finger, then infant 3) Sensor applied to infant, then connected to cable O Donnell CPF, et al. Archives of Disease in Childhood Fetal & Neonatal Edition, O Donnell CPF, et al. Archives of Disease in Childhood Fetal & Neonatal Edition, Page 6 of 17

What s NORMAL for a newborn? Normative study Change over time? Preterm vs. Term? Vaginal vs. Cesarean?

7 O DONNELL, 2005 Conclusions Probe placement technique affects time to first measure. First apply sensor to infant, then attach to cable. Interpretation of Pulse Oximetry? O Donnell CPF, et al. Archives of Disease in Childhood Fetal & Neonatal Edition, What s NORMAL for a newborn? Normative study Change over time? Preterm vs. Term? Vaginal vs. Cesarean? n=468 newborns o No resuscitation, no O2 usage Immediate preductal oximetry Creation of normative curves Preterm Vs. Term Lower SpO2 for preterm infants at all time points Longer transition to achieve SpO2 >90% Page 7 of 17

8 Time to Reach Targets Vaginal versus Cesarean Longer transition for preterm than term infants Not statistically significant at any target SpO2 Lower SpO2 at earliest measure for Cesarean Similar rate of rise, though lagging All Patients 37 Weeks Gestation 32 to 36 Weeks Gestation <32 Weeks Gestation Page 8 of 17

9 Conclusions 5-10min to achieve SpO 2 >90% is NORMAL! Full-term faster than premature Vaginal delivery faster than Cesarean Why is this Important? How Much O 2 Does a Newborn Require? MONITORING OXIMETRY Expected 5-10min transition Less O 2 administration? Initiation of critical care in the delivery room setting Eg. pulse oximetry, O 2 blending Personalization of care Titration of Oxygen Excess O 2 = HARM 1) Vento M, et al. Pediatrics, ) 3) Vento M & Saugstad OD. The Journal of Pediatrics, OXYGEN AT DELIVERY High O 2 o Pro: Rapid oxygenation o Con: Oxidative stress Low O 2 (room air) o Pro: Decreased reactive O 2 species o Con: Increased transition time? Oxygen Usage in the Delivery Room Does Oxygen Exposure in the Delivery Room Affect Outcomes? Vento M & Saugstad OD. The Journal of Pediatrics, Page 9 of 17

10 ESCRIG, 2008 ESCRIG, 2008 Study Groups Prospective, randomized trial n=42; <28wk; immediate oximetry o FiO2 30% (n=19) vs. 90% (n=23) o Target SpO2 85% at 10min o Stepwise 10% O2 adjustments o Response to HR<80 or SpO2 Outcomes achievement of SpO2 target; O2 delivered; RA ventilation Escrig E, et al. Pediatrics, Escrig E, et al. Pediatrics, ESCRIG, 2008 Oxygen Delivery ESCRIG, 2008 FiO2 Escrig E, et al. Pediatrics, Escrig E, et al. Pediatrics, ESCRIG, 2008 SpO2 ESCRIG, 2008 Room Air Titration Low O2 High O2 Escrig E, et al. Pediatrics, Escrig E, et al. Pediatrics, Page 10 of 17

VENTO, 2009 VENTO, 2009 Study Groups Prospective, randomized trial n=78; 24-28wk; immediate oximetry o FiO2 30% (n=37) vs.

2) Oxidative stress/inflammatory markers Vento M, et al. Pediatrics, 2009. Vento M, et al. Pediatrics, 2009. VENTO, 2009 FiO2 VENTO, 2009 SpO2 HR Vento M, et al.

VENTO, 2009 Long-Term Outcomes VENTO, 2009 Oxidative Stress Oxidized / Reduced Glutathione Ratio High-oxygen group: - Longer

11 VENTO, 2009 VENTO, 2009 Study Groups Prospective, randomized trial n=78; 24-28wk; immediate oximetry o FiO2 30% (n=37) vs. 90% (n=41) o Target SpO2: 75% (5min), 85% (10min) o Stepwise 10% titrations Outcomes o 1) Neonatal death or BPD (O2 at 36wk) o 2) Oxidative stress/inflammatory markers Vento M, et al. Pediatrics, Vento M, et al. Pediatrics, VENTO, 2009 FiO2 VENTO, 2009 SpO2 HR Vento M, et al. Pediatrics, Vento M, et al. Pediatrics, VENTO, 2009 Long-Term Outcomes VENTO, 2009 Oxidative Stress Oxidized / Reduced Glutathione Ratio High-oxygen group: - Longer duration of O2 treatment - Long duration of mech. ventilation & CPAP - Higher rate of BPD (13% vs. 6%) Vento M, et al. Pediatrics, Vento M, et al. Pediatrics, Page 11 of 17

VENTO, 2009 Inflammatory Markers TNF-α IL-8 Vento M, et al. Pediatrics, 2009.

12 VENTO, 2009 Inflammatory Markers TNF-α IL-8 Vento M, et al. Pediatrics, VENTO, 2009 Bronchopulmonary Dysplasia Vento M, et al. Pediatrics, KAPADIA, 2013 KAPADIA, 2013 Study Groups Prospective, randomized trial n=88; 24-34wk, immediate oximetry o FiO2 21% (n=44) vs. 100% (n=44) o Titration based on 2010 guidelines Outcomes o 1) Oxidative stress markers o 2) Clinical measures/outcomes Kapadia V, et al. Pediatrics, Kapadia V, et al. Pediatrics, KAPADIA, 2013 Resuscitation KAPADIA, 2013 Resuscitation FiO2 SpO2 Kapadia V, et al. Pediatrics, Kapadia V, et al. Pediatrics, Page 12 of 17

KAPADIA, 2013 Oxidative Stress Resuscitation SpO2 > 94% KAPADIA, 2013 SpO2 < 10%ile Total hydroperoxides

(21-30%); n=321 o High FiO2 (60-100%); n=356 o Varied titration; generally based on 2005 guidelines Clinical

13 KAPADIA, 2013 Oxidative Stress Resuscitation SpO2 > 94% KAPADIA, 2013 SpO2 < 10%ile Total hydroperoxides Biological antioxidant potential Oxidative balance ratio Kapadia V, et al. Pediatrics, Kapadia V, et al. Pediatrics, KAPADIA, 2013 SAUGSTAD, 2014 Systematic review; metaanalysis o 10 randomized studies 32wk GA o Low FiO2 (21-30%); n=321 o High FiO2 (60-100%); n=356 o Varied titration; generally based on 2005 guidelines Clinical outcomes Kapadia V, et al. Pediatrics, Saugstad OD, et al. Acta Paediatrica, SAUGSTAD, 2014 SAUGSTAD, 2014 Mortality Saugstad OD, et al. Acta Paediatrica, Saugstad OD, et al. Acta Paediatrica, Page 13 of 17

SAUGSTAD, 2014 SAUGSTAD, 2014 Bronchopulmonary Dysplasia Intraventricular Hemorrhage Saugstad OD, et al. Acta Paediatrica, 2014.

14 SAUGSTAD, 2014 SAUGSTAD, 2014 Bronchopulmonary Dysplasia Intraventricular Hemorrhage Saugstad OD, et al. Acta Paediatrica, Saugstad OD, et al. Acta Paediatrica, TATARANNO, 2015 Study Groups TATARANNO, 2015 Randomized trial; 2 NICUs (Australia) TO2RPIDO study; subset analysis n=119; < 32wk GA o FiO2 100% (n=60) vs. 21% (n=59) o Titration based on 2005 guidelines Oxidative stress markers Tataranno ML, et al. Acta Paediatrica, Tataranno ML, et al. Acta Paediatrica, TATARANNO, 2015 Resuscitation TATARANNO, 2015 Oxidative Stress Markers Isoprostanes Tataranno ML, et al. Acta Paediatrica, Advanced oxidative protein products Non-protein bound iron Tataranno ML, et al. Acta Paediatrica, Page 14 of 17

15 TATARANNO, 2015 Changes in Oxidative Stress Markers Advanced oxidative protein products Isoprostanes Oxygen Usage in the Delivery Room Putting Theory Into Practice (Changes between 2 and 12 hours after birth) Tataranno ML, et al. Acta Paediatrica, GANDHI, 2013 Transitional Oxygen Targeting System (TOTS) Real-time graphical display of SpO2 target achievement Prospective cohort study Comparison to SpO2 alone Gandhi B, Rich W, & Finer, N. The Journal of Pediatrics, GANDHI, 2013 n=40; 36wk requiring O2 FiO2 40%; titration in 10% increments Goal (TOTS) = 10-50th percentiles from normative curves (32-36wk GA) Goal (Control) = SpO2 70% (3min) and SpO2 80% (5min) Outcome: time in target range Gandhi B, Rich W, & Finer, N. The Journal of Pediatrics, GANDHI, 2013 GANDHI, 2013 Transitional Oxygen Targeting System (TOTS) Control Seconds Gandhi B, Rich W, & Finer, N. The Journal of Pediatrics, Gandhi B, Rich W, & Finer, N. The Journal of Pediatrics, Page 15 of 17

GANDHI, 2013 CONCLUSIONS - 1 Color is an unreliable indicator of oxygenation status Immediate preductal pulse oximetry is now recommended for all delivery room resuscitations Gandhi B, Rich W, &

16 GANDHI, 2013 CONCLUSIONS - 1 Color is an unreliable indicator of oxygenation status Immediate preductal pulse oximetry is now recommended for all delivery room resuscitations Gandhi B, Rich W, & Finer, N. The Journal of Pediatrics, CONCLUSIONS - 2 For fastest SpO2 signal: o 1) Oximeter on; awaiting signal o 2) Apply probe to neonate o 3) Attach probe to oximeter cable SpO2 normative data now available CONCLUSIONS - 3 Titration of O2 in the delivery room affects short- and long-term outcomes Delivery room resuscitation strategies remain an area of ongoing investigation 2015 INTERNATIONAL CONSENSUS FUTURE DIRECTIONS Closed-loop inspired oxygen (CLIO2) Feedback loop between pulse oximeter and FiO2 control Automated FiO2 adjustment COMING SOON Start pulse oximetry Start pulse oximetry Page 16 of 17

17 TAKE-HOME MESSAGE QUESTIONS? Use me! Page 17 of 17

Steven Ringer MD PhD April 5, 2011

Steven Ringer MD PhD April 5, 2011 Disclaimer Mead Johnson sponsors programs such as this to give healthcare professionals access to scientific and educational information provided by experts. The presenter