ARDS Survival: Building A Roadmap to Achieve Successful Short and Long Term Outcomes Kathleen Vollman MSN, RN, CCNS, FCCM, FAAN Clinical Nurse Specialist/Educator/Consultant LLC Director/Ambassador WFCCN ADVANCING NURSING LLC USA kvollman@comcast.net Vollman 2016 www.vollman.com Disclosures Sage Products Speaker Bureau & Consultant Hill-Rom Speaker Bureau & Consultant Eloquest Healthcare Speaker Bureau & Consultant 1
Objectives Demonstrate applied knowledge of the major pathophysiologic manifestations seen in ARDS Apply the 7P s user-friendly structure for implementing evidence-based supportive care practices in the ARDS patient Examine future interventions that demonstrate an impact on both short and long-term outcomes for the ARDS patient The Berlin ARDS Definition Timing Chest Imaging (X-ray or CAT scan) Origin of Edema Within 1 week of a known clinical insult or new/worsening respiratory symptoms Bilateral opacities-not fully explained by effusions, lobar/lung collapse or nodules Respiratory failure not fully explained by cardiac failure or fluid overload; Need objective assessment (e.g. echocardiography) to exclude hydrostatic edema if no risk factors present Mild Moderate Severe Oxygenation < 200 PaO 2 /FiO 2 or < 300 with PEEP/ CPAP > 5 cm H 2 O < 100 PaO 2 /FiO 2 or < 200 with PEEP >5 cm H 2 O < 100 PaO 2 /FiO 2 with PEEP >5 cm H 2 O Mortality 27% (24% to 30%) 32% (29% to 34%) 45% (42% to 48%) Ferguson ND, et al. Intensive Care Med. 2012;38:1573-1582 Dharia A, et al. ICU Director, 2012;3(6):287-292 2
PaO 2 /FiO 2 Ratio User friendly tool Crude assessment of the severity of lung injury Used in the definition of ALI/ARDS ALI: < 300 regardless of PEEP ARDS: < 200 regardless of PEEP PaO2 = 70 torr FiO2 = 60% or.60 P/F Ratio = 70/.60 Answer: 117 Vollman 2016 The Berlin ARDS Definition Timing Chest Imaging (X-ray or CAT scan) Origin of Edema Within 1 week of a known clinical insult or new/worsening respiratory symptoms Bilateral opacities-not fully explained by effusions, lobar/lung collapse or nodules Respiratory failure not fully explained by cardiac failure or fluid overload; Need objective assessment (e.g. echocardiography) to exclude hydrostatic edema if no risk factors present Mild Moderate Severe Oxygenation < 200 PaO 2 /FiO 2 or < 300 with PEEP/ CPAP > 5 cm H 2 O < 100 PaO 2 /FiO 2 or < 200 with PEEP >5 cm H 2 O < 100 PaO 2 /FiO 2 with PEEP >5 cm H 2 O Mortality 27% (24% to 30%) 32% (29% to 34%) 45% (42% to 48%) Ferguson ND, et al. Intensive Care Med. 2012;38:1573-1582 Dharia A, et al. ICU Director, 2012;3(6):287-292 3
Epidemiology, Patterns of Care & Mortality in ICU s in 50 Countries Large observational study to understand the global impact of severe acute respiratory failure (LUNG SAFE) Winter 2014: Four consecutive weeks 459 ICUs from 50 countries across 5 continents Primary outcome measure: ARDS incidence Secondary measures: assessment of clinical recognition, application of vent management, use of adjunct interventions and outcomes for ARDS 10% incidence of ARDS 78% within 48hrs and mechanically ventilated Bellaini G, et al. JAMA, 2016;315(8):788-800 ARDS Prevalence & Mortality By Type Type of ARDS Period Prevalence Hospital Mortality Mild 30% 34.9% Moderate 46.6% 40.3% Severe 23.4% 46.1% Greater incidence, under recognized and higher mortality Bellaini G, et al. JAMA, 2016;315(8):788-800 4
Predisposing Conditions Associated with ARDS Direct Injury Inhalation injuries Pneumonitis Pulmonary Contusion Oxygen Toxicity Drugs: Radiation Indirect Injury Sepsis Multiple Transfusions Shock Multisystem Trauma Pulmonary Embolism Fat Embolism Pancreatitis Intracranial Hypertension Burns Bypass Surgery DIC Pathophysiologic Characteristics in ALI/ARDS A permeability defect described as a diffuse, nonuniform injury to the alveolar epithelium and alveolar capillary membrane (mediator/biotrauma & ventilator induced) Direct injury to pulmonary circulation (mediator/biotrauma & ventilator induced) Defect in the body s ability to transport and utilize O 2 at tissue level Tremblay et al. J of Clinical Inves, 1997,99:944-952 Gajic O et al. Crit Care. Online; April 26 th, 2005 Blondonnet R, e tal. Disease Markers, 2016; open access Manimala R, et al. Current Respiratory Medicine Reviews, 2015;11(3):231-235 5
Biotrauma 6
Ventilator Induced Lung Injury: Parenchymal Injury Known or Suspected Factors: Mechanical stress Larger lung volume (Volutrauma) Higher plateau pressure (Barotrauma) Lower PEEP (Atelectrauma) High RR High FiO 2 Pulmonary Vascular Injury Cause Stress fractures of capillaries Unregulated vasoconstriction (mediators) Vascular clogging/obstruction (micro emboli) Effect Leaky membranes Increased PAP & PVR Pulmonary hypertension/right ventricular dysfunction 7
Pathophysiologic Characteristics in ALI/ARDS A permeability defect described as a diffuse, nonuniform injury to the alveolar epithelium and alveolar capillary membrane (mediator/biotrauma & ventilator induced) Direct injury to pulmonary circulation (mediator/biotrauma & ventilator induced) Defect in the body s ability to transport and utilize O 2 at tissue level Tremblay et al. J of Clinical Inves, 1997,99:944-952 Gajic O et al. Crit Care. Online; April 26 th, 2005 Blondonnet R, e tal. Disease Markers, 2016; open access Manimala R, et al. Current Respiratory Medicine Reviews, 2015;11(3):231-235 8
Clinical Manifestations Refractory hypoxemia Pulmonary shunting Diffuse alveolar and interstitial infiltrates Decreased lung compliance Pulmonary hypertension Other organ system failures Ware LB, N Engl J Med, 2000;342:1334 The Seven P s of ARDS Treatment PREVENTION PEEP PUMP PIPES PARALYSIS POSITION PROTEIN 9
Use of risk stratification tools to apply prevention strategies: Lung Injury Prediction Score (LIPS), Early Acute Lung Injury Score (EALI) Bower RG, et al. Intensive Care Med, 2016;42:772-774 Prevention and Early Treatment of Acute Lung Injury (PETAL Network) The Network will develop and conduct at least 3-5 RCT, s to prevent, treat, and/or improve the outcome of adult patients with, or at risk for acute respiratory distress syndrome (ARDS). One trial focuses on ventilating all patients similar to how we ventilate ARDS pts to prevent progression into ARDS. Low tidal volume 6ml/kg PBW, Plat pressures < 30 cm H2O PEEP > 10cm H2O Population based 8 yr trend study demonstrated used of lower tidal volumes in mechanically ventilated patients resulted in incidence of hospital acquired ARDS. (Li G, et al. Am J Respir Crit Care Med, 2011;183(1):59-66) www.petal.org 10
Reducing Adverse Events Associated with Hospital Acquired ARDS VAE/VAC/IVAC & Probable VAP Inadequate antimicrobial therapy Mechanical ventilation with injurious tidal volumes Volume of blood products & fluid administration Health-care acquired infections Ahmed AH, et al. Crit Care Med, 2014;42:31-39 (Positive End Expiratory Pressure) 11
Lung Protective Ventilation Goal: Pplat = < 30 cm H2O, PaO2=55-88mmHg or SpO2 =88%-95%, start at PEEP of 5cm H2O http://www.ardsnet.org/tools.shtml O 2 Goal slightly higher: 65-75 mmhg & SaO2 90-95% r/t negative cognitive outcome with lower ranges (Bein T, et al. Intensive Care Med,2016;42:699-711) PCV versus VCV for ARF r/t Acute Lung Injury (ALI) or Acute Respiratory Distress Syndrome (ARDS) 3 RCTs (1089 participants) 43 ICUs in Australia, Canada, Saudi Arabia, Spain and the USA. Results: RCTs are insufficient to confirm or refute whether pressure-controlled or volume-controlled ventilation offers any advantage Chacko B, et alcochrane Database of Systematic Reviews 2015, Issue 1. Art. No.: CD008807. DOI: 10.1002/14651858.CD008807.pub2. 12
Low Tidal Volume/FiO2 guided with Higher PEEP & Prone Positioning Wang C, et al. Scientific Report. 6:22855/ www.nat ure.com Best Chance of Survival EBR & Meta-analysis: High Peep vs. Low PEEP 3 trails, 2299 patients No difference in mortality with High vs. Low PEEP for entire population High PEEP vs. Low PEEP in ARDS patients showed significant reduction in mortality p=0.049) Rates of pneumothorax and vasopressor use were similar Briel M. et al. JAMA, 2010;303(9):865-873 Similar Finding in 2013 Cochrane Review for ARDS patients Santa Cruz R, et al. Cochrane Database of Systematic Reviews 2013, Issue 6. Art. No.: CD009098. DOI: 10.1002/14651858.CD009098.pub2. 13
The Data 35.1% received a tidal volume greater than 8ml/kg PBW regardless of severity Pplat pressure was measured in 40% of patients regardless of severity Bellaini G, et al. JAMA, 2016;315(8):788-800 14
Evidence: What is the Purpose if We Do Not Use It? Large variation exist in implementation of the evidence Standardized protocols and monitoring help improve compliance Compliance decreases over time Nurse or respiratory driven protocols improve compliance Jones, TL. Worldviews on Evidence Based Nursing. 2011;8(1):40-50 Unmoh NJ, et al. JAMA. 2008;36:1463-1468 Bellaini G, et al. JAMA, 2016;315(8):788-800 Recruitment Strategies Optimal PEEP Sustained Inflation: 30-40cm of CPAP for 30 seconds (Cardiac & respiratory adverse effects) Prone positioning Cochrane Systematic Review: 7 trial met criteria for inclusion (1170 patients). Results showed no improvement with use of recruitment maneuver with 28 day mortality, risk of barotrauma, blood pressure but did increase oxygenation for short time periods (Hodgson C et al. Cochrane Database of Systematic Reviews, 2011;1) 15
Non Conventional Ventilator Strategies APRV HFOV ECMO APRV: Airway Pressure Release Ventilation Time-triggered, pressure-limited, time cycled Pressure release mechanism allows spontaneous breathing during both inflation & deflation phases Results in longer inflation time Benefits: Recruits more slowly Raised mean airway pressure without increasing applied PEEP Additional spontaneous effort during inflation may enhance recruit and cardiac filling May be more tolerable No demonstrated outcome benefit when compared to ARDS network trial (small # of RCT with low # subjects) Macintyre N. Semin Respir Crit Care Med 2006;7:396-403 Mlcak RP. J of Burn Care & Research, 2009;30:176-177 Bein T, et al. Intensive Care Med,2016;42:699-711) 16
Cochrane Review: High Frequency Oscillation Sud S, et al. Cochrane Database of Systematic Reviews 2016, Issue 4. Art. No.: CD004085. DOI: 10.1002/14651858.CD004085.pub4.BMJ. 2010;18:340:c2327. ECMO in Patients with H1N1 Influenza Infection: Systematic Review and Meta-analysis 1,357 patients with confirmed/suspected H1N1 infection requiring intensive care unit admission 266 (20%) of whom were treated with ECMO Mechanical ventilation before ECMO implementation for a median of two days Mortality range 8-65% Median in-hospital mortality 28% Zangrillo et al. Critical Care 2013, 17:R30 17
Extracorporeal Membrane Oxygenation for Severe Acute Respiratory Distress Syndrome (EOLIA) Phase 3 A B C D E F ASSESS, PREVENT & MANAGE PAIN BOTH SAT & SBT CHOICE OF SEDATION DELIRIUM EARLY MOBILITY FAMILY/PATIENT ENGAGEMENT COORDINATION & COMPREHENSIVE ORAL CARE FEEDING 18
ABC Trial (RCT Paired Sedation & Vent Weaning Protocols) Girard TD, Kress JP,, Light RW,et al. Lancet. 2008;371(9607):126-134. Girard, et al, Lancet. 2008;371:126-34 PMID: 18191684. ABC Trail: Mortality at 1 Year Girard, et al, Lancet. 2008;371:126-34 Girard TD, Kress JP,, Light RW,et al. Lancet. 2008;371(9607):126-134. PMID: 18191684. 19
CDC Prevention Epicenters Wake Up and Breathe Collaborative Prospective quality improvement collaborative Goal: prevent VAEs through less sedation and earlier liberation from mechanical ventilation Mechanism: increase performance of paired daily spontaneous awakening trials and breathing trials (SATs and SBTs) 12 ICUs affiliated with 7 hospitals Klompas M. (CDC ABCDE Collaborative) Am J Respir Crit Care Med. 2015;191:292-301. CDC Prevention Epicenters Wake Up and Breathe Collaborative SATs / SBTs VAEs 63% in SATs 16% in SBTs 37% in VACs 65% in IVACs 81% in SBTs done with sedatives off Klompas M. (CDC ABCDE Collaborative) Am J Respir Crit Care Med. 2015;191:292-301. 20
SAT & SBT Protocol Rescreen tomorrow Is the patient responsive to verbal stimuli? SAT Safety Screen SAT: Can patient go w/o sedation and complications for 4 hours? Rescreen tomorrow SBT Safety Screen Rescreen tomorrow Restart sedation at half dosage, then titrate for pain/sedation SBT: Does patient breathe w/o complications for 2 hours? Notify physician to consider extubation Rescreen tomorrow Measures to Improve Oxygen Delivery 21
Measures to Improve O 2 Delivery Fluid Management Colloid vs. Crystalloids Dry vs. Wet Colloid Versus Crystalloid in ARDS: Meta-analysis 3 RCT, 2 trial & subgroup of the SAFE trial. N=206 Risk of bias unclear or high No difference in morality Improved P/F ratio in colloid group Large RCT Needed Uhlig C, et al. Critical Care, 2014;(R10) 22
ARDS Network: Fluid Management Strategies in ALI (FACT) ARDS Clinical Trials Network. N Engl Med, 2006;354:2564-75 RCT Results: N=1000 Mortality: Conservative: 25.5% Liberal: 28.4% (95% CI, -2.6 to 8.4% p=0.30) Cumulative Fluid balance: Conservative: -136 + 491 ml Liberal: 6992 + 502 ml (p<0.0001) Conservative: VFD (14.6 + 0.5 vs. 12.1 = 0.5 p >0.01 ICU days (13.4 + 0.4 vs. 11.2 = 0.4 p<0.001 Subgroup analysis showed conservative fluid strategy associated with long term neuropsychological impairment Mikkelsen ME, e tal. Am J of Respir Crit Care Med, 2012;185(12):1307-1315 23
Review of Fluid Management: ARDS Network Patients Retrospective review 844 patients from the Low tidal volume study Fluid management was based on physician preference Measured: cumulative fluid balance during 1 st four days compared to VFD, ICU free days, death during hospitalization Results 683 patients averaged > 3.5 L in positive fluid balance 161 patients had a negative fluid balance Lower morality with negative balance on day 4 (20% vs. 37% p=.001) Greater VFD s 15 vs. 10 days; p=.001 ICU free days 13 vs. 9 days; p =.009 Rosenberg Al, et al. J of Intensive Care Med, 2009;24:35-46 Timing of Fluid Administration is Key More fluid early if needed, less fluid later Control the efficacy of volume expansion with predefined goaloriented therapy Consider push-pull after hemodynamically stable /? Hemofiltration (more studies) Early resuscitative fluid administration & later conservative fluid management impacts survival in Septic Shock patients with ALI (Murphy CV, et al. Chest, 2009;136:102-109) 24
Neuromuscular Blockade in Early ARDS Multicenter, double blind trial 340 patients with ARDS within 48hrs of admitted to ICU ARDS defined as P/F ratio of < 150 > PEEP 5cm & Vt of 6-8 ml/kg PBW Randomized to receive 48hrs of cisatracurium or placebo Study did not use train of 4 Results: After risk adjustment NMB group showed improved mortality at 90 days (31.6% vs. 40.7%) Also significant at 28 days time off vent No difference in muscle weakness NNT 10-11 Papazian L, et al. N Engl J Med. 2010;363(12):1107-16 25
Neuromuscular Blocking Agents in ARDS: Systematic Review and Meta-analysis 3 trials (431 patients; 20 centers; all from the same research group in France) All trials assessed 48- hour infusions of cisatracurium besylate. Lower risk of barotrauma No increase in vents days or risk of ICU acquired weakness Alhazzani W, et al. Critical Care, 2013;17:R43 Appropriate Pain & Sedation: Impacting Ventilator Outcomes Daily interruption of sedative drug infusions duration of MV & LOS in the ICU. Duration of mechanical ventilation was by 33% (2.4 days) and ICU LOS was by 35% (3.5 days) and lower impact on PTSD. Wake up and breathe protocol resulted in time on ventilator, ICU & hospital stay and reduced 1 year mortality (NNT=7) Systematic review and meta-analysis of 6 RCTs comparing benzodiazepine vs. non-benzodiazepine ICU sedation regimens: ICU LOS (6 studies) difference of 1.6 days, P= 0.0007, Duration of mechanical ventilation (4 studies) difference of 1.9 days, P< 0.00001 Kress JP, et al. N Engl J Med. 2000;342:1471-1477 Kress JP, et al. AM J Respir Crit Care Med, 2003;168:1457-1461 Girard TD, et al. Lancet, 2008;371-126-134 Fraser G. Crit Care Med. 2013; 41:S30-8 26
Continuous Lateral Rotation Therapy Goldhill DR et al. Amer J Crit Care, 2007;16:50-62 27
Where Does The Prone Position Fit into A Mobility Program for ARDS Patients? Unless otherwise contraindicated prone positioning should be applied as first line therapy to any patient with moderate or severe ARDS and applied as early as possible after identification of hypoxemic ARDS Bein T, et al. Intensive Care Med,2016;42:699-711) Prone positioning was used in 19% of patient with severe ARDS Bellaini G, et al. JAMA, 2016;315(8):788-800 28
Prone Positioning: The Evidence RCT 466 patients with severe ARDS Severe ARDS P/F ratio < 150 mm Hg, with Fio2 0.6, PEEP of at least 5 cm of water, and a tidal volume to 6 ml per kg of PBW Initiation 12-24hrs Prone-positioning 16hrs/or supine position NMB used 5 days Results: Prone 16% mortality, supine 32.8% p< 0.0001 No differences in complications except > cardiac arrest in supine position Guerin C. et al. N Engl J Med, 2013 Prone Positioning in ARDS: A Systematic Review and Meta-analysis Meta-analysis: 11 RCT s (n=2341) 6 trials used lung protective strategies Difference seen with > 16hrs in the position N=11 Sud S, et al. CMAJ 2014. DOI:10.1503 29
Impact on Clinical & Safety Outcomes Pressure ulcer, dislodgement of the ET tube and thoracotomy tube higher in prone position Sud S, et al. CMAJ 2014. DOI:10.1503 30
Outcomes of Early Mobility Program incidence of skin injury time on the ventilator incidence of VAP days of sedation delirium ambulatory distance Improved function Bassett R, et al Intensive & Critical Care Nurs, 2012,28;:88-97 Staudinger t, et al. Crit Care Med, 2010;38. Abroung F, et al. Critical Care, 2011;15:R6 Morris PE, et al. Crit Care Med, 2008;36:2238-2243 Pohlman MC, et al. Crit Care Med, 2010;38:2089-2094 Schweickert WD, et al. Lancet, 373(9678):1874-82. Thomsen GE, et al. CCM 2008;36;1119-1124 Winkelman C et al, CCN,2010;30:36-60 Dickinson S et al. Crit Care Nurs Q, 2013;36:127-140 Bein T, et al. Intensive Care Med,2016;42:699-711 31
Bein T, et al. Intensive Care Med,2016;42:699-711 32
SSCM/ASPEN Nutrition Guidelines (2016) Targeted for ICU pts > 2-3 day LOS Perform a Nutrition screen Initiate enteral nutrition (EN) within 24 48 hours following the onset of critical illness and admission to the ICU and increase to goals over the first week of ICU stay Do not use gastric residual volumes as part of routine care to monitor ICU patients on EN. Take steps as needed to reduce risk of aspiration or improve tolerance to gastric feeding (use prokinetic agent, continuous infusion, chlorhexidine mouthwash, elevate the head of bed, and divert level of feeding in the gastrointestinal tract). Taylor BE, et al. Crit Care Med, 2016: 40(2):159 211. SSCM/ASPEN Nutrition Guidelines (2016) Trophic or full nutrition by EN is appropriate for patients with ARDS/ALI & those expected to have a duration of mechanical ventilation 72 hours (High) ARDS patients: No recommendation for enteral formulation with antiinflammatory lipid and antioxidants conflicting data. Divert to lower in the GI tract in those critically ill patients at high risk for aspiration or those who have shown intolerance to gastric EN (Mod-High) EN withheld until fully resuscitated or stable (Consensus) We suggest that sufficient (high-dose) protein should be provided. Protein requirements are expected to be in the range of 1.2 2.0 g/kg actual body weight per day, and may likely be even higher in burn or multitrauma patients Taylor BE, et al. Crit Care Med, 2016: 40(2):159 211 33
Protocol/Bundle Driven Care Driving Standardization to Impact Short & Long Term Outcomes for ARDS Patients A B C D E F ASSESS, PREVENT & MANAGE PAIN BOTH SAT & SBT CHOICE OF SEDATION DELIRIUM EARLY MOBILITY FAMILY/PATIENT ENGAGEMENT COORDINATION & COMPREHENSIVE ORAL CARE FEEDING 34
The Unsuccessful Eighth P of ARDS Management EBR: Pharmacologic Therapies in ALI/ARDS 33 RCT s, 3272 patients No effect on mortality Prostaglandin E N-Acetylcysteine Early high dose corticosteroids Surfactant Statinsl Some benefit but smaller trials Low dose corticosteroids late phase/ Pentoxifylline (30 patients) (clinical data insufficient) Adhikari, et al. Cochrane Database of Systemic Reviews, 2010 35
Meta-analysis: Nitric Oxide Impact on ARDS Regardless of Severity Methodology: Nine trials (n = 1,142 patients) met inclusion criteria Overall methodological quality was good Results: No significant effect of NO on; Hospital mortality Duration of mechanical ventilation or VFD Significant risk of developing renal dysfunction Nitric oxide does not reduce mortality in adults or children with acute respiratory distress syndrome, regardless of the degree of hypoxemia. Adhikari NK, et al. Crit Care Med 2014; 42:404 412 Long Term Outcomes 36
Post Intensive Care Syndrome Harvey M, Davidson J. Crit Care Med, 2016;44(2):381-385 Recovery & Outcomes for ARDS Patients and Family Hospital discharge: Cognitive impairment 70 to 100% 1 yr post discharge: Cognitive impairment 46 to 86% 5 yrs post discharge: Cognitive impairment 20% Mood disorders and PTSD sustain and prevalent ICU acquired weakness resulting in functional disabilities and can been seen for up to 8 yrs following critical illness Significant resource utilization during hospitalization and 2-3 years out from initial stay http://www.icudelirium.org/testimonials.html Herridge MS, et al. Intensive Care Med, 2016;42:725-738 37
Preventing Progression Improving recognition Bundling of Supportive Care New Ventilator Modes New Pharmacological agents The Future It Takes a Village Coming together is a beginning. Keeping together is progress. Working together is success. Henry Ford 38
It is not enough to do your best; you must know what to do, and THEN do your best. ~ W. Edwards Deming 39