Draeger Neonatal Conference Dallas, Texas May 30, Biomedical Applications of PFC. Thomas H. Shaffer, MS.E., PhD
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1 Draeger Neonatal Conference Dallas, Texas May 30, 2012 Biomedical Applications of PFC Thomas H. Shaffer, MS.E., PhD Professor of Pediatrics and Physiology A.I. dupont Hospital for Children Thomas Jefferson School of Medicine Temple University School of Medicine Overview: Early Studies Concepts Bench Data Pre-Clinical Animal Studies Clinical Studies Preterm Infant Studies CDH Studies Hypothermia
2 Physicochemical Properties ( ATM) Gas Solubility *Oxygen *Carbon Dioxide Vapor Pressure Density Viscosity ml/ 100 ml PFC ml/ 100 ml PFC torr g/ml cs Gabriel, et al. Amer Soc Art Intern Org (ASAIO), 1996.
3 Control Transfusion 1% Hb Prevention of Decompression Sickness Rapid Decompression Gas Emboli in Microcirculation
4 Mice as Men
5 Mouse Movie Courtesy Lee Clark Schematic of Demand-Regulated Liquid Breathing System 1989 Shaffer and Moskowitz, J. Appl Physiol. 1974
6 During TLV Demand-Regulated Liquid Ventilation Post TLV Shaffer and Moskowitz, J. Appl Physiol. 1974
7 Perfluorochemical Assisted Ventilation Tidal Liquid Ventilation Present Partial Liquid Ventilation Present Aerosol Ventilation Present
8 Liquid Ventilation in Preterm Lambs Treatment Oxygenation Improvement Shaffer et al. Pediatr. Res., 1976
9 PaO 2 CMV PLV TLV Wolfson MR and Shaffer TH: Pediatr Respir Rev 6(2): 117, 2005.
10 SF Treated Preterm Lambs: 120 days Gestation CMV PLV TLV Wolfson MR and Shaffer TH: Pediatr Respir Rev 6(2): 117, Non-RespiratorySupport Applications: Drug Delivery Imaging Lung Expansion Induction of Hypothermia
11 Cullen et al. Respir Med. 93(11):770, 1999
12
13 Carina 3D Image No PFC PFC 4 th Generation 3D Image No PFC PFC
14 Preterm Infants Clinical Studies CDH Infants Hypothermia Greenspan JS et. al. Lancet (2)8671:1095, 1989 Greenspan JS et. al. J Pediatr. 117: ,1990
15 Preterm MultiCenter Trial wks GA.or BW= gms. < 48 hrs of Age At least 2 doses of SF < 30 days old a/a <0.2 MAP > 10 cmh 2 O Compliance < 0.3 ml/ cmh 2 O/kg Leach et.al., NEJM, 1996.
16 Partial Liquid Ventilation in Premature Newborns LiquiVent Study Group- N Engl J Med, 1996
17 Phila. Liquid Ventilation Consortium. Pediatrics 99(1):E2, 1997 Lung Changes During Distension With PFC 0 Hrs Distension 48 Hrs Distension
18 Phila. Liquid Ventilation Consortium. Pediatrics 99(1):E2, 1997 Survival: PILG = 6 of 8 (75%) Control = 2 of 5 (40%) Results VFD: PILG = days, Control = days Time on ECMO: PILG = days, Control = days Patients (n) VFD (days) Time (days) Survival VFD Time on ECLS Control PILG Control Control P=0.50 P=0.90 PILG PILG Died Survived P=0.58
19 Conclusions PILG can be performed safely PILG may be of benefit in the management of newborns with CDH who require ECLS. A definitive trial of this novel intervention in neonates with high mortality is ongoing. RhinoChill approach: The aim is the brain Brain is the target organ Heart is controlled by the brain Puppet on a string Myriad autonomic efferents Transnasal route: Nasal cavity is a heat exchanger sitting right under the brain
20 PFC Nasal Cooling System O 2 PFC Mean Brain Cooling ( C) Comparison of Brain Cooling Rates NasoPharyngeal Cooling Therapeutic Hypothermic Zone Cooling Blanket Time (minutes) Wolfson et al. NeuroCrit Care 8(3):437-47, 2008.
21 Design 11 sites 84 patients Single arm All arrests Sep 07- Aug 08 Primary objective Safety and feasibility of early post- ROSC cooling using RhinoChill Secondary end-points Minutes to initiate cooling Minutes to target temperature 42
22 Cooling is quickly initiated Collapse Cooling begun within 35 minutes of hospital arrival Therapeutic temperature (34C) reached in 27 min. 33C target temperature reached in 60 min. 43 Cooling in the ICU is easily managed 44
23 RhinoChill advantage Easy, non-invasive catheter placement Simple to integrate with other emergency procedures Portability enables continued cooling in various clinical environments & scenarios Fast brain with consecutive central cooling Pre-hospital use is a natural application
24 Design 15 sites/ems systems 200 patients RCT Nov 08 Jul 09 Primary objective Safety and feasibility of intra-arrest cooling using RhinoChill Secondary end-points ROSC rate Minutes to target temperature Survival to discharge Neurologically intact survival 47 RhinoChill Portable Device
25 Cooled head faster ROSC RhinoChill No RhinoChill Hospital ArrivalSystemic Cooling Started RhinoChill on RhinoChill off 3 hours faster Increased survival for admitted patients RhinoChill No RhinoChill N=30 N=42
26 FUTURE CARE!!!!
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