Fisiología Respiratoria, Hipercapnia Permisiva e Injuria Pulmonar. Wally A. Carlo, M.D. University of Alabama at Birmingham

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1 Fisiología Respiratoria, Hipercapnia Permisiva e Injuria Pulmonar Wally A. Carlo, M.D. University of Alabama at Birmingham

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4 Randomized Trial of Oxygen Saturation Targets in Premature Infants - the SUPPORT Trial Randomized Trial of Early CPAP versus The SUPPORT Surfactant Study in Extremely Group of Preterm the Eunice Kennedy Infants Shriver NICHD Neonatal The SUPPORT Research Network Trial The SUPPORT Study Group of the Eunice Kennedy Shriver NICHD eon at al R esear Neonatal ch N et wresearch or k Network NEONATAL RESEARCH NETW ORK NICHD

5 Background Surfactant treatment at less than 2 hours of life significantly decreases death, air leak, and death or bronchopulmonary dysplasia (BPD) in preterm infants - but not BPD alone However, no surfactant studies had a comparison group who received early CPAP Retrospective cohort studies demonstrated that the early use of CPAP in very preterm infants with respiratory distress may decrease mechanical ventilation without increased morbidity and without surfactant

6 BACKGROUND CONSENSUS CONFERENCE To minimize side effects, blood gas targets do not have to be in the normal ranges Assisted ventilation may lead to adverse consequences Gas trapping (dynamic hyperinflation) and alveolar overdistention may lead to lung damage and should be limited ACCP Conference. Chest 104:1833, 1993.

7 Permissive Hypercapnia: Background - Rationale Maintenance of normocapnia in some patients with severe respiratory failure necessitates high ventilatory support Compensated respiratory acidosis is generally well tolerated and may reduce lung injury Clinical studies show trend or significant benefits of a limited ventilation strategy with permissive hypercapnia

8 LUNG INJURY DURING ASSISTED VENTILATION 1. Chest wall restriction limits pressure-induced lung injury (Hernandez, et al., 1988) 2. Overexpansion of the thorax with negative pressures causes lung injury (Dreyfus, et al., 1988)

9 VOLUME vs PRESSURE IN LUNG INJURY Pulm. Epith. Hyaline Lymph Filtr. Volume Pressure Edema Injury Memb. Flow Coef. IPPV High High Yes Yes Yes Yes Yes Iron Lung High Low Yes Yes Yes N/A N/A Strapping Low High No No No No No Dreyfus et al, 1988; Bshouty et al, 1988; Hernandez et al, 1989; Corbridge et al, 1990; Carlton et al, 1990

10 EFFECT OF TIDAL VOLUME ON LUNG COMPLIANCE 3 8 cc/kg Compliance (cc/cmh 2 O kg) cc/kg 32 cc/kg Age (min) Bjorklund et al., 39:326A, 1996.

11 EFFECT OF TIMING INFLATION ON LUNG VOLUTRAUMA Compliance (cc/cmh 2 O kg) After Surfactant Before Surfactant Age (min) Ingirmarsson et al. Pediatr Res 41:255A, 1997.

12 WHICH VOLUMES CAUSE LUNG INJURY? Volutrauma Zone Overdistention Time Volutrauma Zone A B C D Atelectasis High V T low PEEP B Normal V T, high PEEP C Normal V T low PEEP D Optimal ventilation W. Carlo 2003

13 C C 20 Volume Above FRC (ml) cmh 2 O P max 0.8 P max High inflection point Low inflection point 20

14 PERMISSIVE HYPERCAPNIA: BACKGROUND Why worry about PaCO 2? Is it not volutrauma that causes lung injury?

15 PREVENTION OF VOLUTRAUMA Low tidal volume Decreased CO2 elimination Hypercapnia High ventilator rate (inefficient) Permissive hypercapnia

16 Hypothesis Early CPAP with a limited ventilator strategy would reduce the incidence of death or survival with BPD at 36 weeks compared to early surfactant

17 Method Patients Inborn infants of 24 0/7 to 27 6/7 weeks gestation for whom a decision had been made to provide full resuscitation were eligible Antenatal Parental consent was obtained Enrollment from February 2005 to February 2009 Randomization was stratified by center and by gestational age (24 and 25 weeks; 26 and 27 weeks)

18 Factorial Design Infants also randomized to 2 ranges of SpO 2 using purpose-built blinded oximeters

19 CPAP Intervention In the delivery room, CPAP at 5 cm H 2 O was provided until NICU admission using a T-piece resuscitator, a neonatal ventilator, or an equivalent methodology Intubation only for infants who required intubation for resuscitation based on standard NRP indications, not performed for the surfactant administration Intubated infants given surfactant

20 Methods CPAP/Limited ventilation Delivery Room 5 cm H 2 O Intubation per NRP If intubated, surfactant Intubation/ Surfactant Considered if: FiO 2 > 0.5 PaCO 2 > 65 mmhg Hemodynamic instability Surfactant Standard NRP Prior to 1 hour

21 Methods: Extubation Criteria Within 24 hrs of meeting all criteria CPAP/Limited ventilation FiO 2 < 0.50 and MAP <10 cm PaCO 2 < 65 mmhg Vent rate < 20 bpm Hemodynamically Stable Surfactant FiO 2 < 0.35 and MAP < 8 cm PaCO 2 < 50 mmhg Vent rate < 20 bpm Hemodynamically Stable Ventilator rate < 20 bpm Hemodynamically stable

22 Methods Duration of Intervention The criteria for both arms were in effect for the first 14 days of life, following which the infant was treated as per NICU standard practice. For both arms, intubation could be performed at any time for the occurrence of repetitive: 1. apnea requiring bag and mask ventilation 2. clinical shock 3. sepsis, and/or 4. the need for surgery

23 Methods BPD Definitions For the primary outcome, BPD was defined using the physiologic definition: - receipt > 30% oxygen at 36 weeks - need for positive pressure support -if FiO 2 < 30%, oxygen withdrawal performed Pre-specified secondary outcomes included the evaluation of BPD defined by the receipt of oxygen at 36 weeks.

24 Methods Sample Size Estimate Baseline rate of BPD/Death of 50% Absolute risk difference of 10% Increased by 1.12 to allow for multiples randomized to same treatment Increased by 1.17 to adjust for attrition Increased further to minimize Type I error using a conservative 2% level of significance Final sample size was 1310 infants

25 Methods Data Analysis The primary and categorical outcomes were analyzed using Poisson regression implementation in a Generalized Estimating Equation (GEE) model to obtain adjusted relative risk and 95% CI Continuous outcomes were analyzed using mixed effects linear models to produce adjusted means and standard errors Adjustment was performed for pre-specified stratification (center and GA) and for familial clustering as multiple births were randomized to the same treatment arms

26 3546 Infants were assessed for eligibility (3127 pregnancies)* 235 Did not meet eligibility criteria 125 Personnel/Equipment not available 699 Eligible but consent not sought 344 Parent unavailable for consent 748 Consent denied by parent or guardian 11 Excluded for other reasons 68 Consented but not randomized 1316 Underwent randomization 663 Were assigned CPAP 653 Were assigned Surfactant 94 Died before discharge 569 Survived to discharge, transfer one year of life 114 Died before discharge 539 Survived to discharge, transfer or one year of life 223 BPD Physiologic 346 No BPD Physiologic 219 BPD Physiologic 320 No BPD Physiologic

27 Results Patient Population CPAP (N = 663) Surfactant (N = 653) Birthweight* Gestational age* to 25 6/7ths (%) to 27 6/7ths (%) Race, White/Black/Hispanic (%) 38 / 38 / / 42/ 19 Antenatal corticosteroids (%) Multiple births (%) *Mean ± Standard Deviation

28 Results Primary Outcome CPAP N=663 Surfactant N=653 Adjusted Relative Risk (95% CI) Death or BPD (Physiologic) 47.8% 51.0% 0.95 (0.85, 1.05) BPD - Physiologic 39.2% 40.6% 0.99 (0.87, 1.14) Death by 36 weeks PMA 14.2% 17.5% 0.81 (0.63, 1.03)

29 Results Delivery Room Variable CPAP (N=663) Surfactant (N=653) Relative Risk for CPAP vs. Surfactant (95% CI) Adjusted P- value Apgar at 1 minute <3 23.3% 25.6% 0.92 (0.76, 1.11) 0.38 Apgar at 5 minutes <3 3.9% 4.9% 0.82 (0.5, 1.34) 0.43 PPV in the DR 65.7% 92.9% 0.71 (0.67, 0.75) <0.001 Intubated in DR 34.4% 93.4% 0.37 (0.34, 0.42) <0.001 DR intubation for resuscitation 32.6% 27.0% 1.21 (1.02, 1.43) 0.02 Surfactant DR/NICU 67.1% 98.9% 0.67 (0.64, 0.71) <0.001 Epinephrine in DR 2.0% 4.1% 0.48 (0.25, 0.91) 0.02

30 Results Other Pre-specified Outcomes CPAP N=663 Surfactant N=653 Relative Risk or Difference in Means BPD (O 2 use at 36 wks) 40.2% 44.3% 0.94 (0.82, 1.06) Death/BPD, 36 wks 48.7% 54.1% 0.91 (0.83, 1.01) Severe ROP- survivors 13.1% 13.7% 0.94 (0.69, 1.28) Any air leaks (14 days) 6.8% 7.4% 0.89 (0.6, 1.32) Mechanical Vent Survivors * (median days) Alive and off MV at 7 days 55.3% 48.8% 1.14 (1.03, 1.25)* Postnatal steroids for BPD 7.2% 13.2% 0.57 (0.41, 0.78)* * = p<0.05

31 SUPPORT Other Results No differences in the incidence of: PDA, PDA requiring surgery NEC, medical or surgical Severe IVH/PVL In the 24 to 25 weeks strata CPAP infants had a lower mortality than Surfactant infants: CPAP 23.9% vs Surfactant 32.1% Relative Risk difference 0.74 (0.57, 0.98)

32 Causes of Death wk Strata CPAP Surfactant Contributory Cause of Death (N=68) (N=90) Respiratory distress syndrome 13/68 (19.1) 31/90 (34.4) Bronchopulmonary dysplasia 10/68 (14.7) 7/90 (7.8) Infection 14/68 (20.6) 15/90 (16.7) Necrotizing enterocolitis 10/68 (14.7) 16/90 (17.8) Central nervous center insult 11/68 (16.2) 5/90 (5.6) Immaturity 3/68 (4.4) 5/90 (5.6) Other 7/68 (10.3) 11/90 (12.2)

33 SUMMARY There was no significant difference for primary outcome of death or BPD More CPAP infants were alive and off mechanical ventilation by day 7 (p=0.011) CPAP infants received less postnatal steroids for BPD (p<0.001) and required fewer vent days (p=0.03) CPAP Infants 24 to 25 6/7 weeks had a significantly lower mortality rate while hospitalized (p<.01) CPAP infants did not have increased morbidities

34 CONCLUSIONS Early CPAP with a limited ventilator strategy for the extremely low birth weight infant is associated with decreased exposure to intubation and mechanical ventilation, decreased death in the most immature infants, without any increase in measured morbidities All surviving infants will be followed to months for a complete neurodevelopmental assessment

35 What about other major trials of early CPAP/permissive hypercapnia?

36 CT of CPAP vs. Ventilation (COIN Trial): Methods Design: Multicenter RCT Subjects: 25 0/7 to 28 6/7 week infants, breathing at 5 min. Intervention: CPAP at 8 cmh 2 O vs. intubation/surfactant Intubation criteria for CPAP group ph< 7.25 PaCO 2 > 60 mmhg; FiO 2 > 0.60; and/or apnea Morley et al. NEJM 358; 700, 2008

37 RCT of CPAP vs. Ventilation (COIN Trial) 610 subjects, 960 ± 215 gm, 94% got ANS CPAP Intubation RR CI p value N=307 N=303 BPD 28d/death 54% 65% <0.05 BPD 36w/death 34% 39% NS Pneumothorax 9% 3% <0.001 Days on ventilator 3 4 <0.001 Pneumothorax rate increased in the CPAP group (3 to 9%, p<0.003) Mortality, days of ventilatory support, days of O 2, hospital stay, IVH ¾, PVL, NEC, PDA ligation, ROP, home O 2 and steroid treatment did not differ between the groups Morley et al. NEJM 358; 700, 2008

38 RCT of CPAP vs. Ventilation (CURCPAP Trial) CPAP Surfactant p Value BPD/death (%) NS Pneumothorax 1 7 NS (%) IVH 3-4 (%) 8 6 NS Sandri et al. Pediatrics 125;31402, 2010

39 RCT of CPAP vs. Ventilation (VON Trial ) 648 infants 26 to 29 weeks Clinical Status at 36 weeks PMA Outcome Death or CLD (ALL) PS N=209 NCPAP N=223 RR (95%CI) (vs PS) 36% 30% 0.83 (0.64, 1.09) Death (ALL) 7% 4% 0.57 (0.25, 1.27) Death or major morbidity 39% 34% 0.88 (0.68, 1.12) Soll et al PAS Vancouver 2010

40 Early CPAP vs Surfactant in Very Low Birth Weight Infants CPAP Surfactant Results (n=131) (n=125) p-value GA 30 wks 30 wks NS Birth Weight 1196 ( ) gm 1197 ( ) gm NS Oxygen at 36 wks (%) 7 10 NS Death (%) 8 10 NS Pneumothorax (%) 3 6 NS IVH (3-4 (%) 5 6 NS Mechanical Vent (%) <0.001 Surfactant (%) <0.01 J. Tapia. PAS 2010

41 RCT of CPAP vs. Ventilation (Rojas Trial) 279 infants from 27 to 31 wks Compared CPAP to intubation/surfactant and extubation within 1 hr of birth CPAP group had lower BPD/death rates 54 vs 63% (NS) Air leaks higher in CPAP 9% vs 2% Rojas et al Pediatrics 2009;123:137-42

42 Results - Demographic Variables Minimal Vent Routine Vent p value (N=109) (N=111) Birth weight (gm) 742 ± ± 135 NS Gestational age (wk) 25 ± 2 25 ± 2 NS Antenatal steroid (%) NS Surfactant (%) NS Male (%) NS Race (%) B/W/O 46/39/15 48/43/9 NS Randomization age (hr) 6.5 ± ± 2.8 NS Carlo et al. J Pediatr 41:370, 2002

43 SAVE Trial Results - Primary Outcome Measures Minimal Routine Ventilation Ventilation RR CI (N=109) (N=111) Mortality or BPD (%) ( ) Mortality (%) ( ) BPD (%) ( ) Carlo et al. J Pediatr 41:370, 2002

44 SAVE Trial Results - Secondary Analyses Minimal Routine Ventilation Ventilation RR CI NNT Ventilation at 36 wk (%) ( )* 7 BPD or death in gm (%) ( )* 6 *p<0.05 Carlo et al. J Pediatr 41:370, 2002

45 SAVE Trial Results - Long-term Follow-up Minimal Routine Ventilation Ventilation RR CI Death or NDI (%) ( ) NDI (%) ( ) CP (%) ( ) Carlo et al. J Pediatr 41:370, 2002

46 Summary of Major Trials of Early CPAP and/or Permissive Hypercapnia BPD/Death CPAP/PHC Experimental Control ARR Carlo (2002) 63% 68% 5% Morley (2008) 34% 39% 5% Rojas (2009) 54% 63% 9% Soll (2010) 30% 36% 6% Finer (2010) 48% 51% 3% Neocosur/Tapia (2010) 15% 19% 4% CURPAP/Sandri (2010) 21% 22% 1%

47 ummary of Major Trials of Early CPAP and/or Permissive Hypercapnia Preliminary meta-analysis SUPPORT, COIN, VON, Neocosur, CURPAP and Rojas BPD/Death CPAP/PHC Control 624/1568 (40%) 689/1538 (45%) RR % CI 0.81; 0.96

48 Early CPAP vs Early Surfactant ELBW Infants Death or BPD at 36 Weeks Study CPAP Surfactant OR (fixed) OR (fixed) or sub-category n/n n/n 95% CL 95% CL COIN NEJM 104/ / (0.58, 1.12) CURPAPS Peds 5/103 5/ (0.29, 3.64) SUPPORT NEJM 323/ / (0.65, 1.00) VON / / (0.64, 1.29) Total (95%, CI) 39%/ %/ (0.71, 0.97) Total events: 500 (CPAP), 614 (Control) Test for heterogeneity: ChF=0.48, df=3 (P=0.92), F=0% Test for overall effect: Z=2.28 (P=0.02) Finer Favours treatment Favours control

49 Early CPAP vs Early Surfactant ELBW Infants Death at 36 Weeks Study CPAP Surfactant OR (fixed) OR (fixed) or sub-category n/n n/n 95% CL 95% CL COIN NEJM 20/307 18/ (0.67, 2.13) CURPAPS Peds 11/103 9/ (0.51, 3.22) SUPPORT NEJM 94/ / (0.68, 1.06) VON /223 30/ (0.26, 1.19) Total (95%, CI) 10%/ %/ (0.64, 1.04) Total events: 134 (CPAP), 171 (Surfactant) Test for heterogeneity: ChF=2.78, df=3 (P=0.43), F=0% Test for overall effect: Z=1.64 (P=0.10) Finer Favours treatment Favours control

50 Early CPAP vs Early Surfactant ELBW > 27 weeks Death or BPD at 36 Weeks Study CPAP Surfactant OR (fixed) OR (fixed) or sub-category n/n n/n 95% CL 95% CL COIN NEJM 51/207 62/ (0.46, 1.11) CURPAPS Peds 22/72 18/ (0.65, 2.79) SUPPORT NEJM 144/ / (0.58, 1.41) VON / / (0.64, 1.29) Total (95%, CI) 32%/880 36%/ (0.69, 1.01) Total events: 285 (CPAP), 383 (Surfactant) Test for heterogeneity: ChF=2.59, df=3 (P=0.46), F=0% Test Finer for overall effect: Z=1.86 (P=0.06)

51 So What Should I Do In My Daily Practice? Suggestions for ELBW/ELGAN Infants 1. Use CPAP instead of intubation and surfactant as the mode of initial support 2. If intubated (FiO 2 > 50%,PCO 2 >65, ph < 7.20, others): give surfactant 3. Attempt to wean the ventilator if PCO 2 < 55-65, ph > 7.20, FiO 2 < 50%

52 Thanks to the many parents, infants, and NICU staff Special Thanks to the Research Coordinators of the NRN Study Funded by the NICHD and NHLBI

53 NICHD Neonatal Research Network Centers ( ) Brown University Case Western Reserve Univ Duke University Emory University Indiana University RTI International Stanford University Tufts Medical Center University of Alabama Birmingham University of California San Diego University of Cincinnati University of Iowa University of Miami University of New Mexico University of Rochester University of Texas, Southwestern Dallas University of Texas Houston University of Utah Wake Forest University Wayne State University Yale University

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