Dott. Carlo Artico Scuola di Specializzazione in Anestesia, Rianimazione e Terapia Intensiva Università degli Studi di Udine Dir. Prof. G.

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1 Dott. Carlo Artico Scuola di Specializzazione in Anestesia, Rianimazione e Terapia Intensiva Università degli Studi di Udine Dir. Prof. G. Della Rocca

2 High-Flow Nasal Cannula (HFNC) O2/air total flow of up to 60 L/min heated and humidified delivered through a heated circuit Nishimura Journal of Intensive Care (2015) 3:15

3 High-Flow Nasal Oxygen MOST OF THE AVAILABLE DATA FROM THIS TECHNIQUE HAS BEEN PUBLISHED IN THE NEONATAL FIELD WHERE IT IS INCREASINGLY USED Mayfield S, Jauncey-Cook J, Hough JL, Schibler A, Gibbons K, Bogossian F. High-flow nasal cannula therapy for respiratory support in children. Cochrane Database Syst Rev. 2014;3:CD doi: / Dani C, Pratesi S, Migliori C, Bertini G. High flow nasal cannula therapy as respiratory support in the preterm infant. Pediatr Pulmonol. 2009;44(7):629 34

4 HFNC Recent use with critically ill adults has been rising It has been applied to a variety of patients with diverse underlying diseases Advantages over conventional oxygen delivery systems, resulting in better physiological effects Many clinical trials, no results from reliable, large, controlled clinical trials have yet been published Nishimura Journal of Intensive Care (2015) 3:15

5 HFNC Physiological effects 1. High flow washes out CO2 in anatomical dead space ( ) 2. Flow creates positive nasopharyngeal pressure, that is considered adequate to increase lung volume or recruit collapsed alveoli (PEEP) 3. FIO2 remains relatively constant (Real FiO2) 4. Mucociliary functions remain good and little discomfort is reported Nishimura Journal of Intensive Care (2015) 3:15

6 HFNC - Indications and Contraindications Hypercapnic respiratory failure Hypoxemic respiratory failure Post-extubation Pre-intubation oxygenation Sleep apnea Acute heart failure Others (Bronchoscopy; DNI; ) Contraindications?....NO absolute contraindications Nishimura Journal of Intensive Care (2015) 3:15

7 PRIMARY OBJECTIVE To determine whether HFNC oxygen therapy was not inferior to BiPAP for preventing or resolving acute respiratory failure after cardiothoracic surgery

8 Multicenter (6 French ICU), Randomized, Noninferiority trial 830 PATIENTS WHO HAD UNDERGONE CARDIOTHORACIC SURGERY (coronary artery bypass; valvular repair; pulmonary thromboendarterectomy) + 1. FAILURE OF A SPONTANEOUS BREATHING TRIAL (SBT) SaO2 < 90% with 12 L of oxygen during a T-tube trial or PaO2 < 75mmHg with FIO2 50% during low level pressure support 2. SUCCESSFUL SBT IN PATIENTS WITH POSTEXTUBATION ARF RISK FACTORS BMI > 30, LVEF < 40%, failure of previous extubation 3. SUCCESSFUL SPONTANEOUS BREATHING TRIAL FOLLOWED BY FAILED EXTUBATION PaO2:FIO2 < 300 AND/OR RR > 25/min for at least 2 hours AND/OR use of accessory respiratory muscles or paradoxic respiration EXCLUSION CRITERIA: contradindications to NIV

9 PRIMARY OUTCOME >>> FAILURE RATE - need to reintubate - need to switch to the other study treatment - patient refusal to continue the randomly allocated study treatment SECONDARY OUTCOMES: - dyspnea score changes over time - skin breakdown and patient comfort - changes over time in the respiratory and hemodynamic variables - number of fiberoptic bronchoscopies during the ICU stay - number of episodes of postoperative pneumonia and consumption of antibiotics - ICU and hospital stay durations.

10 forza STATISTICAL ANALYSIS The absolute difference in the frequency of treatment failure between BiPAP and low-flow oxygen therapy is 16% (95% CI, 1.9%-29.4%) FerrerM et Al. Am J Respir Crit Care Med. 2006;173(2): With an estimated BiPAP fail in 20% of patients and the lower bound of the 95% confidence for benefit set at 2%, noninferiority margin was set at 9% according to data reported by Ferrer et al Noninferiority of high-flow nasal oxygen therapy would be demonstrated if the lower boundary of the 95% CI were less than 9%. The noninferiority hypothesis applied only to the primary end point. For all secondary outcomes, the hypothesis is that HFNC therapy is superior to BiPAP

BIPAP THROUGH FULL-FACE MASK Psupp, starting at 8 cmh2o, to achieve Vt = 8 ml/kg RR < 25/min. PEEP set at 4 cmh2o FiO2 = 50% initially Then adjusted to maintain SaO2 at 92% to 98%.

12 BIPAP THROUGH FULL-FACE MASK Psupp, starting at 8 cmh2o, to achieve Vt = 8 ml/kg RR < 25/min. PEEP set at 4 cmh2o FiO2 = 50% initially Then adjusted to maintain SaO2 at 92% to 98%. BiPAP for 2 hours then for approximately 1 hour every 4 hours, or more if needed to achieve clinical respiratory stability. Between BiPAP sessions, oxygen via a standard nasal cannula, simple face mask, or nonrebreathing mask to maintain SaO2 at 92% or higher High-flow humidified oxygen (37 C and 44mgH2O/L) continuously Initial flow rate was 50L/min Initial FIO2 = 50% Subsequent adjustments to maintain SaO2 at 92%to 98%.

13 Time of ABG collection during study forza

14 RESULTS (1)

15 forza RESULTS: Primary Outcome

16 forza RESULTS: Primary Outcome TREATMENT FAILURE BiPAP: 91 of 416 patients (21.9%; 95% CI, 18.0%-26.2%) HFNC: 87 o f414 (21.0%; 95% CI, 17.2%-25.3%) Risk difference 0.9% (95% CI, 4.9%to 6.6%) P =.003) HIGH-FLOW NASAL OXYGEN THERAPY IS NOT INFERIOR TO BIPAP

17 forza RESULTS: Composite Primary Outcome Reintubation: BiPAP :57 pts (13.7%) HFNC: 58 pts (14.0%) (P =.99)

18 forza RESULTS: Composite Primary Outcome Switching to the other study treatment BiPAP: 33 patients with BiPAP(7.9%;95%CI,5.6%-11.0%) HFNC: 45 (10.8%; 95% CI, 8.5%-14.9%) (P =.15) Premature discontinuation BiPAP :15(3.6%;95%CI, 2.1%-6.0%) HFNC: 6 (1.4%;95% CI,0.6%-3.3%) (P =.04)

19 forza RESULTS Respiratory support was required throughout the first 3 days for 304 patients: in the BiPAP group in the HFNC group

20 forza RESULTS PaO2/FIO2 increased from day 1 to day 3 in both groups - BiPAP group: From 160 (95%CI, ) to 187 (95%CI, ) - HFNC group: From 136 (95% CI, ) to 157 (95%CI, ) (P <.001)

21 forza RESULTS

22 forza RESULTS

23 Criticità nello studio in esame Scelta del gruppo di controllo Dimensioni del limite di non inferiorità Scelta di un outcome composito

24 Scelta del gruppo di controllo La letteratura riguardo alla NIV post Cardiochirurgia è relativamente scarsa Probabilmente sarebbe stato più utile (e più semplice..) confrontare l HFNC con una terapia standard (coinvolgente o meno la NIV)

25 STUDI DI NON INFERIORITÀ Gli studi di non inferiorità hanno intuitivamente senso quando vengono considerati nuovi trattamenti che possono essere più confortevoli e applicabili o avere meno effetti collaterali 1. Ragioni della scelta 2. Motivazione della scelta del comparator, sia sottolineando che è il miglior trattamento esistente, sia citandole prove della sua efficacia 3. la definizione del margine di equivalenza o di non inferiorita, esponendo le ragioni della sua scelta, in particolare della sua accettabilità clinica 4. le procedure che hanno portato al calcolo della dimensione del campione, tenendo conto del margine Δ Rischio PRIICIPALE è quello di dichiarare non inferiore il nuovo trattamento anche quando esso e notevolmente meno efficace del trattamento standard Gotzsche PC. Lessons from and cautions about non inferiority and equivalence randomized trials. JAMA 2006; 295:

26 forza STATISTICAL ANALYSIS The absolute difference in the frequency of treatment failure between BiPAP and low-flow oxygen therapy is 16% (95% CI, 1.9%-29.4%) FerrerM et Al. Am J Respir Crit Care Med. 2006;173(2): With an estimated BiPAP fail in 20% of patients and the lower bound of the 95% confidence for benefit set at 2%, noninferiority margin was set at 9% according to data reported by Ferrer et al Noninferiority of high-flow nasal oxygen therapy would be demonstrated if the lower boundary of the 95% CI were less than 9%. The noninferiority hypothesis applied only to the primary end point. For all secondary outcomes, the hypothesis is that HFNC therapy is superior to BiPAP

27 MARGINE DI NON INFERIORITA Intervallo di confidenza del 9% è ampio Nel nostro caso HFNC potrebbe potenzialmente risultare in un aumento dl rischio di fallimento terapeutico del 4.9%

28 forza RESULTS: Primary Outcome TREATMENT FAILURE BiPAP: 91 of 416 patients (21.9%; 95% CI, 18.0%-26.2%) HFNC: 87 o f414 (21.0%; 95% CI, 17.2%-25.3%) Risk difference 0.9% (95% CI, 4.9%to 6.6%) P =.003) HIGH-FLOW NASAL OXYGEN THERAPY IS NOT INFERIOR TO BIPAP

29 Outcome composito Importanza clinica relativa dei 3 sottogruppi che compongono l outcome Considerazioni all interno dei 3 singoli gruppi (per esempio se l effetto dell intervento terapeutico o gli endpoint all interno dei singoli sottogruppi sono costanti)

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