Neonatal High Flow Nasal Cannula Towards A Clinical Practice Guideline Bradley A. Yoder, MD Professor of Pediatrics Division of Neonatology University of Utah School of Medicine

Disclosure Statement I have received research and/or travel compensation as a consultant to Drager Medical Fisher & Paykel Vapotherm & Ikaria

Objectives Recognize Detrimental Approaches Suggest Clinical Guidelines Identify Areas for Further Research

Contributing Consultants Clare Collins, MBChB, PhD, FRACP. Department of Paediatrics, Mercy Hospital for Women, Melbourne, AU (CCollins@mercy.com.au) Kevin Ives, MBBChir, , MD, FRCPCH. Dept of Neonatology, John Radcliffe Hospital, Oxford, UK (Kevin.Ives@nhs.net) Brett Manley, MB BS (Hons.), PhD, FRACP. Consultant Neonatologist Neonatal Services and Newborn Research Centre, Royal Women's Hospital Department of Obstetrics and Gynaecology, The University of Melbourne, Melbourne, AU (Brett.Manley@thewomens.org.au) Michael McQueen, MD, MBA, FAAP. Neonatology, Banner Health System, Phoenix, AZ, USA (Michael.McQueen@bannerhealth.com) Bradley A. Yoder, MD, FAAP. Division of Neonatology, University of Utah School of Medicine, SLC, UT, USA (bradley.yoder@hsc.utah.edu)

Why Do We Need Practice Guidelines?

Why Do We Need Practice Guidelines? HHFNC universally available in US NICU’s Expanding international use Increasing pediatric & adult use Only a few RCT’s have been completed Guidelines generally improve outcomes Assist in identifying areas to improve

HHHFNC - Mechanisms of Action Process References Gas condition Reduced metabolic work Maintain epithelial integrity Improved lung mechanics Greenspan, JPeds 1991 Williams, CCM 1996 Waugh, RespCare 2004 Schiffmann, RCCNA 2006 Chidekel, PulmMed 2012 Pressure Minimal if: small NC coupled w/ large nasal interface Increases EELV Saslow, J Perinatol 2006 Kubicka, Peds 2008 Wilkinson, J Perinatol 2008 Frizzola, PedsPulm 2011 Sivieri, PedsPulm 2012 Collins, JPaedsChildH 2013 Hough, PedsCCM 2014 Flow Dead space gas washout Inspiratory resistance Augment tidal volume Off-loads diaphragm activity Shepard, ARRD 1990 Dewan, Chest 1994 Rubin, PedsCCM 2014 Pham, PedsPulm 2014

HHHFNC Randomized Clinical Trials Post-extubation HHHFNC v CPAP - preemies < 32 wks C Collins (Melbourne, AU; n=132) B Manley (Melbourne, AU; n= 300) Post-extubation HHHFNC v CPAP Liu C (China; n= 255) Comparison of HHHFNC to Nasal CPAP in Neonates B Yoder (University of Utah, n = 432; 150 < 32 wks) Initial Rx for RDS HHHFNC v CPAP - preemies < 35 wks A Kugelman (Haifa, Israel; n=76)

Summary of Current RCT’s HHHFNC: ~ 1200 infants in 5 trials Similar failure rates as nCPAP As applied, no evidence for increased adverse events….particularly air leaks Does not extend O2 use or hospital stay Primarily relates to post-extubation use

Issues in Clinical Care Cannula to nares ratio Gas egress Temp & humidity Initial Flow Rate Escalation/weaning flow NG v OG tube PO feeding on HFNC

Initial Set-up MUST maintain a leak at the nose avoids excessive pressure generation allows nasopharyngeal ‘washout’ more comfort & less nasal trauma Keep temperature close to 37o C Position tubing down & away from baby minimize fluid into the nares/airway reduces risk for pressure injuries

Occlusive NC Non-occlusive NC

Critical Points Only use heated and humidified systems Typical peak inspiratory flow ~ 1 lpm, thus when flow > wt in kg, set FiO2 = delivered FiO2 HFNC is a non-invasive Rx: treat it like CPAP titrate FiO2 first, then flow rate if an infant needs > 50-60% oxygen  D modes know when to bail (apnea, acidosis, hypoxia.…)

Indications for HHHFNC Post-extubation support for preterm infants Current evidence shows equivalence to CPAP Data is limited for infants born < 26 weeks’ GA Infants stable on CPAP, where HFNC therapy may be preferred A variety of reasons may be offered including ease of care, neuro-developmental, nasal trauma, other

Unproven Benefit As primary support for RDS or other acute neonatal respiratory disorder Lack of evidence from RCT’s But empirically used by many centers

Management of Flow Rate Initiating flow: Dependent on size &/or gestation Dependent on 1o v 2o Rx Dependent on current Paw/FiO2 Criteria for escalation: FiO2 Respiratory rate RDS score/WOB Radiograph Approach to weaning: Time on HF FiO2 Respiratory exam

Management of HHHFNC Therapy Weight EGA Current Rx Mode PAW FiO2 Resp Rate Time On Exam RDS-S Initial flow rate N = 4 Y = 1 N = 5 N = 3 Y = 2 N = 1 Y = 4 Y = 5 Flow Escalation N = 2 Y = 3 Weaning Flow The majority of consultants use the infants underlying clinical condition, rather than weight or gestation, to manage HHHFNC

What criteria do you use in initiating HHHFNC therapy in neonates? Flow Rate “A” “B” “C” “D” “E” Current weight < 1000 g 1000-2000 g > 2000 g 5-7 lpm 3-5 lpm 5-8 lpm 8 lpm 4-6 lpm all wts 4-6 lpm all wts all wts all wts 4-8 lpm Postnatal age < 24 hrs < 7 days other 5-7 lpm all Same 5-8 lpm all 8 lpm all 4-6 lpm all as above Prior Rx mode HFV SIMV CPAP Other NO Same 5-8 lpm 8 lpm Same as 6-7 lpm as above; 5-8 lpm for all above; 5-7 lpm includes Rarely Occ <28 wk Don’t use CPAP HFV may go NIMV/CPAP FiO2 < 40% < 30% RA 7-8 lpm by 1 lpm 7-8 lpm 8 lpm 6-8 lpm if 5-7 lpm Same 5-8 lpm for all FiO2 > 40% 5-7 lpm as above otherwise 4-6 lpm PAW < 8 cm H2O < 6 cm H2O 6-8 lpm Same Same 8 lpm 4-6 lpm all 5-7 lpm as above for all for all typically not Only @ CPAP < 7 Same successful if > 9-10 7-8 lpm if Flow need based WOB on all of above

Initiation of HHHFNC Therapy Weight FiO2 PAW Initial flow rate “A” 5-7 lpm @ any weight “B” Varies by wt 3-8 lpm “C” 5-8 lpm @ any weight “D” 8 lpm @ any weight “E” 4-6 lpm @ any weight Increase for > 30% Always start at 8 lpm Increase for > 6-7 cm H2O Same as for weight Same; poor success rate if > 9-10 at extubation Gestation & postnatal age not a factor

Consensus Recommendations Initiating High Flow Use only heated/humidified systems Use NC sized to allow ready egress of gas Start at 5-8 lpm no evidence comparing starting flow rates consider increased flow based on FiO2/Paw/WOB

What criteria do you use in escalating HHHFNC therapy in neonates? Increase in Flow Rate “A” “B” “C” “D” “E” Current weight < 1000 g 1000-2000 g > 2000 g Don’t use Don’t use Don’t use Don’t use Don’t use Postnatal age < 24 hrs < 7 days other Don’t use Don’t use Don’t use Don’t u se Don’t use FiO2 < 40% < 30% > 21% > 30% use by 1-2 lpm by 1 lpm If FiO2 by 1-2 lpm 7-8 lpm if > 30% as FiO2 flow back if > 40% by 1 lpm to 8 lpm Resp rate < 60 60-80 > 80 As above only if > 60 by 1 lpm by 1 lpm by 1 lpm for FiO2 only if signs by 1 lpm by 1-2 lpm by 1 lpm WOB/distress RDS score or WOB Specify by 1 lpm by 1-2 lpm by 1 lpm As above As above Time on HHFNC < 6 hrs < 12 hrs > 12 hrs > 24 hrs No time Same as Same As above Do not use limit “A” Don’t wait more time epochs D to CPAP than 1-2 hrs to Consider Depends on baby if HFNC = 8 lpm escalate to D to CPAP Do not use CPAP & concerns CPAP/NIMV or NIMV Occ use BiPAP

Consensus Recommendations Escalating High Flow Don’t exceed 8 lpm flow in neonates Increase flow for: WOB Respiratory rate FiO2 Don’t delay in escalating flow Change to CPAP/NIMV if not improving

What criteria do you use in escalating HHHFNC therapy in neonates? Increase in Flow Rate “A” “B” “C” “D” “E” Current weight < 1000 g 1000-2000 g > 2000 g Don’t use Don’t use Don’t use Don’t use Don’t use Postnatal age < 24 hrs < 7 days other Don’t use Don’t use Don’t use Don’t u se Don’t use FiO2 < 40% < 30% > 21% > 30% use by 1-2 lpm by 1 lpm If FiO2 by 1-2 lpm 7-8 lpm if > 30% as FiO2 flow back if > 40% by 1 lpm to 8 lpm Resp rate < 60 60-80 > 80 As above only if > 60 by 1 lpm by 1 lpm by 1 lpm for FiO2 only if signs by 1 lpm by 1-2 lpm by 1 lpm WOB/distress RDS score or WOB Specify by 1 lpm by 1-2 lpm by 1 lpm As above As above Time on HHFNC < 6 hrs < 12 hrs > 12 hrs > 24 hrs No time Same as Same As above Do not use limit “A” Don’t wait more time epochs D to CPAP than 1-2 hrs to Consider Depends on baby if HFNC = 8 lpm escalate to D to CPAP Do not use CPAP & concerns CPAP/NIMV or NIMV Occ use BiPAP

What criteria do you use in weaning HHHFNC therapy in neonates? Decrease in Flow Rate “A” “B” “C” “D” “E” Current weight < 1000 g 1000-2000 g > 2000 g Wean qod q 12-24 hrs qod if Keep 8 lpm 0.5 lpm q D q 12-24 hrs < 1500 g til > 1 kg 1 lpm q D Wean q12 q 4-12 hrs 1-2 kg by 1 lpm q 24 1 lpm prn > 2 kg as tolerated Postnatal age < 24 hrs < 7 days other Don’t use Wean as NO As above Don’t use above unless “bigger” baby FiO2 < 40% < 30% RA No wean Same Same As above if 0.5 lpm if CLD if > 30-35% FiO2 stable otherwise as & < 40% above for WT Resp rate < 60 60-80 > 80 No wean Same Same No wean No wean if RR>60 if > 80 if > 80 RDS score or WOB Specify No wean Same Same Same Same Decreased WOB & FiO2 drive weaning more rapidly among larger infants Stick to slower wean for smaller/younger infants Time on HHFNC < 6-12 hrs > 12 hrs > 24 hrs If “quick” recover Same Same Not a Not a from RDS WOB more a factor factor factor For ELBW p-ext than time except for ELBW wean qod if FiO2 > 25%

Consensus Recommendations Weaning High Flow Wean the FiO2 first, then the gas flow Similar to CPAP; to at least < 35%, probably < 30% Review at least every 12-24 hrs to determine if flow rate can be weaned or discontinued May be able to wean infants > 2 kg more quickly Wean by 0.5 - 1 lpm decrements

Stopping HHHFNC Therapy Weight EGA Postnatal Age “A” 4 lpm * “B” 1-2 lpm @ < 1000g; 2-3 lpm at higher weights “C” 3 lpm - “smaller” babies “D” 4 lpm * “E” 2-3 lpm for VLBWI, prefer to “dry” low-flow NC “A” Rarely < 4 lpm w/ BPD “B” Same as weight “C” 3-4 lpm if larger/older “D” Same as weight “E” Same as weight “A” Same as weight “C” Expect “smaller” on 3-5 lpm for 2-3 wks Preferably stable > 24 hrs, FiO2 < 30% and normal WOB/RR * 1o related to funding issues

Consensus Recommendations Discontinuing High Flow There is no consensus on when to D/C HF No studies comparing effect or outcomes related to D/C HFNC at different support levels Recommendations vary from 1 – 4 lpm Centers vary by weight of infant Also variation related to support for BPD

CONSENSUS ! THIS WOULD WORK A LOT BETTER IF YOU’D JUST AGREE WITH ME

Consensus on HHHFNC: A Tale of Two NICU’s Preferred Non-Invasive Approach by NICU RN’s Au data from Roberts CT, J Paeds Child Health 2014; UK data from K Ives, unpublished

The Future Challenges are what make life interesting …… …… overcoming them is what makes life meaningful Joshua J. Marine

Future Studies Additional large RCTs are needed: to evaluate HHHFNC use in ELBWIs to compare different HHHFNC devices to evaluate various approaches to HHHFNC to assess economic impact of HHHFNC to address specific respiratory conditions other

. V I G I L A N C E You can’t see it if you don’t stay awake

SUMMARY HHHFNC is in wide clinical use RCT’s support HHHFNC as safe, effective alternative to nCPAP at the time of extubation Additional RCT’s are needed to study HHHFNC as 1o therapy & related to flow management Except for stopping, there is moderate consensus in the management of HHHFNC

Contributing Consultants Clare Collins, MBChB, PhD, FRACP. Mercy Hospital for Women, Melbourne, AU Kevin Ives, MBBChir, , MD, FRCPCH. John Radcliffe Hospital, Oxford, UK Brett Manley, MB BS (Hons.), PhD, FRACP. The University of Melbourne, Melbourne, AU Michael McQueen, MD, MBA, FAAP. Banner Health System, Phoenix, AZ, USA

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