NIPV N ON -I NVASIVE P OSITIVE -P RESSURE V ENTILATION IN THE A CUTE -C ARE S ETTING 4/10 Thom Petty BS RRT Lead Ventilation Solutions Specialist – Eastern & Midwestern U.S. CareFusion Respiratory Technologies - Ventilation

OBJECTIVES 2 A brief history of NIPV Selecting the equipment Selecting the patient Disease-specific utilizations Implementing NIPV at your Hospital

3 A BRIEF HISTORY OF NIPV

THE EARLY DAYS The delivery of mechanical ventilatory support without the use of an invasive artificial airway was first described in the 1940’s. NIPV quickly lost favor as invasive ventilators and interfaces became more available. NIPV maintained a minor presence in Hospitals in the form of IPPB treatments.

A SLOW RETURN Continuous CPAP via nasal mask for O.S.A. apnea 1987 – NIPV via nasal mask for Muscular Dystrophy and post-op muscle weakness Successful treatment with NIPV via full-face mask in 8 out of 10 ARF patients.

PRESENT DAY 1990’s - Introduction of improved bi-level ventilators such as the Philips BIPAP ST/D facilitated NIPV in the ICU and other acute- care settings. 1990’s - Introduction of improved bi-level ventilators such as the Philips BIPAP ST/D facilitated NIPV in the ICU and other acute- care settings. Articles and studies on the use of NIPV has increased ten-fold since the mid-90’s. Articles and studies on the use of NIPV has increased ten-fold since the mid-90’s. Increased utilization particularly in non-US hospitals Increased utilization particularly in non-US hospitals Difficult to quantify the extent of its use. Difficult to quantify the extent of its use.

THREE REASONS FOR NIPV NIPV can be used for: Intermittent support for chronic respiratory failure such as COPD & OSA. Intermittent support for end-of-life dyspnea. Rapidly growing alternative method to relieve dyspnea without depressing respiratory drive. Continuous support for patients in acute respiratory failure

BENEFITS OF NIPV IN ARF For the patient in Acute Respiratory Failure, NIPV may offer a number of advantages over invasive PPV. Avoidance of intubation-related trauma Decreased incidence of nosocomial pneumonia Enhanced patient comfort Shorter duration on ventilatory-support device Reduction in hospital stay Reduced cost

WHY NIPV? NIPV is now the accepted treatment for acute- on-chronic respiratory failure (exacerbation of COPD), acute cardiogenic pulmonary edema, and some forms of hypoxemic respiratory failure, to facilitate weaning in selected patients and to prevent extubation failure in high-risk patients. Epstein & Kacmarek, Respiratory Care, 54:1

SELECTING THE APPROPRIATE EQUIPMENT

GOALS & OBJECTIVES OF MECHANICAL VENTILATION Minimize risks Minimize risks Optimize ventilation/perfusion ratio with adequate ABG’s Optimize ventilation/perfusion ratio with adequate ABG’s Maximize safety Maximize safety Avoid VILI and VAPS Avoid VILI and VAPS Promote patient comfort Promote patient comfort Avoid patient-ventilator dysynchrony Avoid patient-ventilator dysynchrony Liberate patient from ventilator as quickly as possible Liberate patient from ventilator as quickly as possible Adhere to weaning criteria and protocols Adhere to weaning criteria and protocols Chatburn, Respiratory Care, 54:1

SELECTING NIPV EQUIPMENT NIPV can be delivered utilizing the following devices: NIPV can be delivered utilizing the following devices: Volume-Controlled Ventilator Volume-Controlled Ventilator Pressure-Controlled Ventilator Pressure-Controlled Ventilator Bilevel Positive Airway Pressure (BIPAP) Ventilator Bilevel Positive Airway Pressure (BIPAP) Ventilator Continuous Positive Airway Pressure (CPAP) Device Continuous Positive Airway Pressure (CPAP) Device NIPV is delivered through a nasal or facial mask or interface appropriate for noninvasive ventilation NIPV is delivered through a nasal or facial mask or interface appropriate for noninvasive ventilation Simpler CPAP & BiPAP masks may leak too much for NIPV use. Simpler CPAP & BiPAP masks may leak too much for NIPV use.

SELECTING NIPV EQUIPMENT Previously limited to BiPAP/CPAP devices. Previously limited to BiPAP/CPAP devices. Significant disadvantages. Significant disadvantages. Can’t deliver precise O2 concentrations Can’t deliver precise O2 concentrations Single limb circuit can cause rebreathing of exhaled CO2 Single limb circuit can cause rebreathing of exhaled CO2 Very basic alarms and monitoring capabilities Very basic alarms and monitoring capabilities Advances in conventional ventilators now provides a wider choice: Advances in conventional ventilators now provides a wider choice: Precise O2 delivery Precise O2 delivery Dual limb circuits eliminate rebreathing of CO2 Dual limb circuits eliminate rebreathing of CO2 Sophisticated alarms and monitoring capabilities. Sophisticated alarms and monitoring capabilities. Can be problematic Can be problematic

SELECTING NIPV INTERFACE Interface choice requires careful evaluation of the patient's characteristics, ventilation modes, and type of acute respiratory failure. Interface choice requires careful evaluation of the patient's characteristics, ventilation modes, and type of acute respiratory failure. Every effort should be made to: Every effort should be made to: Minimize air leaks Minimize air leaks Maximize patient comfort Maximize patient comfort Optimize patient-ventilator interaction Optimize patient-ventilator interaction Minimize dynamic, apparatus and physiologic dead space Minimize dynamic, apparatus and physiologic dead space Heating and humidification may be needed to prevent adverse effects from cool dry gas. Heating and humidification may be needed to prevent adverse effects from cool dry gas.

SELECTING THE EQUIPMENT Chatburn, Respiratory Care, 54:1

SELECTING THE APPROPRIATE PATIENT

SELECTING THE PATIENT The most important decision that a clinician makes that will directly affect the success or failure of NIPV is the selection of the appropriate patient on whom NIPV will be applied.

GENERAL GUIDELINES Consider NIPV for Acute Respiratory Distress secondary to: Consider NIPV for Acute Respiratory Distress secondary to: AE-COPD AE-COPD Acute pulmonary edema Acute pulmonary edema Pneumonia Pneumonia Asthma Asthma

SELECTING THE PATIENT Clinical inclusion criteria – acute respiratory distress Clinical inclusion criteria – acute respiratory distress Moderate to severe dyspnea Moderate to severe dyspnea Respiratory rate greater than 24 BPM Respiratory rate greater than 24 BPM Accessory muscle use Accessory muscle use Abdominal paradox Abdominal paradox Worsening Arterial Blood Gases Worsening Arterial Blood Gases

SELECTING THE PATIENT Not all patients are candidates for NIPV Not all patients are candidates for NIPV The patients ability to protect their airway is one of the most important considerations when selecting the appropriate patients. The patients ability to protect their airway is one of the most important considerations when selecting the appropriate patients. Not optimal in an anxious and uncooperative patient Not optimal in an anxious and uncooperative patient The patient must be adequately prepared. The patient must be adequately prepared. Explain procedure Explain procedure Properly fit the mask Properly fit the mask Inspiratory and Expiratory pressures should be increased gradually. Inspiratory and Expiratory pressures should be increased gradually.

SELECTING THE PATIENT Factors predictive of NIPV success in the treatment of ARF: Factors predictive of NIPV success in the treatment of ARF: Younger age Younger age Lower acuity of illness Lower acuity of illness Cooperative patient Cooperative patient Ability to coordinate breathing with NIPV device. Ability to coordinate breathing with NIPV device. Improvement in gas exchange, heart rate and respiratory rate within first 2 hours after initiation of NIPV. Improvement in gas exchange, heart rate and respiratory rate within first 2 hours after initiation of NIPV. Patients not having a favorable initial response to NIV should be considered for intubation without delay. Patients not having a favorable initial response to NIV should be considered for intubation without delay.

SELECTING THE PATIENT THE PENUELAS STUDY Retrospective look at 8080 mechanically ventilated pts Retrospective look at 8080 mechanically ventilated pts 1080 patients initially ventilated with NPPV patients initially ventilated with NPPV. Reason for initiating NPPV Reason for initiating NPPV Congestive Heart Failure25% Congestive Heart Failure25% COPD21.5% COPD21.5% Community Acquired Pneumonia13% Community Acquired Pneumonia13% ARDS6% ARDS6% Other chronic pulmonary disease 6% Other chronic pulmonary disease 6% Acute Respiratory Failure5% Acute Respiratory Failure5% Hospital Acquired Pneumonia5% Hospital Acquired Pneumonia5% Other (trauma, aspiration, sepsis, neurologic disease) <3%. Other (trauma, aspiration, sepsis, neurologic disease) <3%. Penuelas - Am J Respir Crit Care Med 183;2011:A3741

SELECTING THE PATIENT THE PENUELAS STUDY Interfaces Interfaces Oral-nasal mask 50% Oral-nasal mask 50% Facial mask 43% Facial mask 43% Failure of NPPV was reported in 314 patients (29.1%). Failure of NPPV was reported in 314 patients (29.1%). Age (odds ratio per year 0.98; CI 95% 0.97 to 0.99) Age (odds ratio per year 0.98; CI 95% 0.97 to 0.99) SAPS II (O.R. per point 1.04; CI 95% 1.02 to 1.05) SAPS II (O.R. per point 1.04; CI 95% 1.02 to 1.05) Home-NIV(O.R. 0.42; CI95% 0.22 to 0.89) Home-NIV(O.R. 0.42; CI95% 0.22 to 0.89) Community pneumonia (O.R. 1.98; CI95% 1.24 to 3.17) Community pneumonia (O.R. 1.98; CI95% 1.24 to 3.17) Hospital pneumonia(O.R. 4.16; CI95% 2.19 to 7.92) Hospital pneumonia(O.R. 4.16; CI95% 2.19 to 7.92) ARDS (O.R. 5.02; CI95% 2.72 to 9.29). ARDS (O.R. 5.02; CI95% 2.72 to 9.29). Penuelas - Am J Respir Crit Care Med 183;2011:A3741

PATIENT CONTRAINDICATIONS Post Respiratory Arrest Post Respiratory Arrest Inability to use mask (trauma, surgery) Inability to use mask (trauma, surgery) Excessive secretions Excessive secretions Hemodynamic instability or life threatening arrhythmia. Hemodynamic instability or life threatening arrhythmia. High risk of aspiration High risk of aspiration Impaired mental status (uncooperative) Impaired mental status (uncooperative) Life threatening hypoxemia (PaO2 <60 with FIO2 of 1.0) Life threatening hypoxemia (PaO2 <60 with FIO2 of 1.0)

EFFECTIVENESS OF NIPV Effectiveness of NIPV should be determined clinically Effectiveness of NIPV should be determined clinically Decreased Respiratory Distress Decreased Respiratory Distress Increased Patient comfort Increased Patient comfort Improved ABG’s and Capnography Improved ABG’s and Capnography NIPV has been shown to reduce WOB in direct proportion to the level of inspiratory pressure-assist, and also by the ability of applied positive end-expiratory pressure (PEEP) to counter intrinsic PEEP. NIPV has been shown to reduce WOB in direct proportion to the level of inspiratory pressure-assist, and also by the ability of applied positive end-expiratory pressure (PEEP) to counter intrinsic PEEP. In general an inspiratory pressure-support level of 15 cmH2O and a PEEP of 5 cmH2O reduced most measures of WOB and inspiratory effort toward normal. In general an inspiratory pressure-support level of 15 cmH2O and a PEEP of 5 cmH2O reduced most measures of WOB and inspiratory effort toward normal. Kallet & Diaz, Resp.Care 54:1

EFFECTIVENESS OF NIPV Patient–ventilator asynchrony is common in patients receiving NIV for acute respiratory failure. Patient–ventilator asynchrony is common in patients receiving NIV for acute respiratory failure. Leaks play a major role in generating patient–ventilator asynchrony and discomfort Leaks play a major role in generating patient–ventilator asynchrony and discomfort Measurement of Vti and Vte Measurement of Vti and Vte Vignaux, Intensive Care Medicine, 2009

COMPLICATIONS Patients on NIPV should be carefully monitored, and attention should be given to their comfort. Patients on NIPV should be carefully monitored, and attention should be given to their comfort. Watch for developing dyspnea Watch for developing dyspnea Watch for decreased O2 Saturations Watch for decreased O2 Saturations Watch for increased respiratory rate Watch for increased respiratory rate Watch for deteriorating mental status Watch for deteriorating mental status Watch for increased respiratory secretions Watch for increased respiratory secretions

COMPLICATIONS Localized facial tissue damage due to pressure of the mask and straps. Localized facial tissue damage due to pressure of the mask and straps. Gastric distention Gastric distention Insert NG tube to relieve gastric distention Insert NG tube to relieve gastric distention Eye irritation Eye irritation Sinus pain or congestion. Sinus pain or congestion. Air leaks at the facial seal are common Air leaks at the facial seal are common Appear to not decrease the benefits of NIPV. Appear to not decrease the benefits of NIPV. Hemodynamic compromise with NIPV is uncommon Hemodynamic compromise with NIPV is uncommon Preload reduction & hypotension may occur with higher pressures. Preload reduction & hypotension may occur with higher pressures.

DISEASE-SPECIFIC UTILZATION WHAT DOES THE LITERATURE SAY?

WHAT’S IN THE LITERATURE? Tremendous growth in past two decades in the study of NIPV Tremendous growth in past two decades in the study of NIPV Most randomized control trials (RCT’s) have been small and have used endotracheal intubation or NIPV failure as outcomes. Most randomized control trials (RCT’s) have been small and have used endotracheal intubation or NIPV failure as outcomes. NIPV for the treatment of ARF in patients with COPD seems to be strongly supported by studies. NIPV for the treatment of ARF in patients with COPD seems to be strongly supported by studies. RCT-based evidence for patients with Asthma, Pneumonia, and Chest- wall Injuries is lacking. RCT-based evidence for patients with Asthma, Pneumonia, and Chest- wall Injuries is lacking.

COPD 17 RCT’s have been published comparing NIPV to conventional therapy in patients with COPD. 17 RCT’s have been published comparing NIPV to conventional therapy in patients with COPD. Shown to reduce treatment failure rate, intubation rate, and hospital mortality in patients with severe COPD. Shown to reduce treatment failure rate, intubation rate, and hospital mortality in patients with severe COPD. Evidence suggests, but is less strong, of similar results in patients with moderate COPD Evidence suggests, but is less strong, of similar results in patients with moderate COPD In acute-exacerbation of COPD patients, a trial of NIPV should be considered early in the course of respiratory failure, and before severe acidosis ensures, as a means of avoiding endotracheal intubation, reducing mortality and treatment failure. In acute-exacerbation of COPD patients, a trial of NIPV should be considered early in the course of respiratory failure, and before severe acidosis ensures, as a means of avoiding endotracheal intubation, reducing mortality and treatment failure. Ram & Lightowler, Cochrane Database System Review, 2004

ASTHMA Only a few small studies have been conducted on NIPV in patients with Asthma. Only a few small studies have been conducted on NIPV in patients with Asthma. Results trend towards a benefit of NIPV in asthmatic patients but the evidence thus far is weak. Results trend towards a benefit of NIPV in asthmatic patients but the evidence thus far is weak. In patients with severe acute asthma, the addition of NIV to standard medical therapy probably accelerates the improvement in lung function, decreases the inhaled bronchodilator requirement, and shortens the ICU and hospital stay, but a larger study is required to settle this issue. In patients with severe acute asthma, the addition of NIV to standard medical therapy probably accelerates the improvement in lung function, decreases the inhaled bronchodilator requirement, and shortens the ICU and hospital stay, but a larger study is required to settle this issue. Gupta & Nath, RespCare May 2010

ALI & ARDS Only a few RCT’s have been designed to specifically study the efficacy of NIPV on patients with ALI/ARDS. Only a few RCT’s have been designed to specifically study the efficacy of NIPV on patients with ALI/ARDS. Auriant et al (2001) Auriant et al (2001) Reduced incidence of intubation & mortality in post-lung- resection patients. Reduced incidence of intubation & mortality in post-lung- resection patients. Ding et al (2009) Ding et al (2009) NPPV may be the first-line intervention for a selected group of ARDS patients NPPV may be the first-line intervention for a selected group of ARDS patients Invasive ventilation should be considered for patients with: Invasive ventilation should be considered for patients with: Worsening of vital signs after short course Worsening of vital signs after short course Worsening ABG analysis after short course Worsening ABG analysis after short course Pulmonary infection is the underlying cause of ARDS. Pulmonary infection is the underlying cause of ARDS.

COMMUNITY ACQUIRED PNEUMONIA Confalonieri et al (1999) Confalonieri et al (1999) Significantly reduced need for intubation and shorter ICU stays for COPD patients with CAP Significantly reduced need for intubation and shorter ICU stays for COPD patients with CAP No difference for patients without underlying COPD. No difference for patients without underlying COPD.

CARDIOGENIC PULMONARY EDEMA Widely used to alleviate signs and symptoms of respiratory distress due to cardiogenic pulmonary edema. Widely used to alleviate signs and symptoms of respiratory distress due to cardiogenic pulmonary edema. Prevents alveolar collapse Prevents alveolar collapse Redistributes alveolar fluid Redistributes alveolar fluid Improves pulmonary compliance Improves pulmonary compliance Reduces the work of breathing Reduces the work of breathing Goal is to decreasing respiratory distress with respect to conventional oxygen therapy until edema can be resolved. Goal is to decreasing respiratory distress with respect to conventional oxygen therapy until edema can be resolved.

CARDIOGENIC PULMONARY EDEMA Essentially two modalities used in this setting: Essentially two modalities used in this setting: Continuous positive airway pressure (CPAP) Continuous positive airway pressure (CPAP) Bilevel pressure support ventilation (BiPAP) Bilevel pressure support ventilation (BiPAP) Neither technique has been found to be superior to the other in comparative analyses Neither technique has been found to be superior to the other in comparative analyses Significant tendency to reduce hospital mortality observed in acute pulmonary edema patients treated with CPAP. Significant tendency to reduce hospital mortality observed in acute pulmonary edema patients treated with CPAP. NIPV, especially CPAP, in addition to standard medical care is an effective and safe intervention for the treatment of adult patients with acute cardiogenic pulmonary edema. NIPV, especially CPAP, in addition to standard medical care is an effective and safe intervention for the treatment of adult patients with acute cardiogenic pulmonary edema. Vital et al, Cochrane Database Review, July 2008 Masip, Curr Opin Crit Care, 14:5

CHEST TRAUMA To date no RCT’s have been conducted on the efficacy of NIPV in Chest Trauma To date no RCT’s have been conducted on the efficacy of NIPV in Chest Trauma Bollinger et al Bollinger et al NIPV with epidural anesthesia vs invasive ventilation NIPV with epidural anesthesia vs invasive ventilation Decreased hospital stay with fewer complications with NIPV. Decreased hospital stay with fewer complications with NIPV. Gunduz et al Gunduz et al CPAP vs endotracheal intubation CPAP vs endotracheal intubation Decreased ICU stay and mortality with CPAP. Decreased ICU stay and mortality with CPAP. Studies suggest that patients with Chest Trauma that don’t require immediate intubation may benefit from CPAP or NIPV instead of prophylactic intubation. Studies suggest that patients with Chest Trauma that don’t require immediate intubation may benefit from CPAP or NIPV instead of prophylactic intubation.

WEANING WITH NIPV Burns et al (2009) Burns et al (2009) BMJ meta-analysis of 12 trials investigating the use of early extubation to NIPV from 1998 – 2008: BMJ meta-analysis of 12 trials investigating the use of early extubation to NIPV from 1998 – 2008: Strong evidence that NIV weaning was associated with reduced mortality Strong evidence that NIV weaning was associated with reduced mortality Decreased incidence of VAP Decreased incidence of VAP Reduced LOS in ICU and hospital Reduced LOS in ICU and hospital At present, use of NIPV to facilitate weaning in mechanically ventilated patients, with predominantly chronic obstructive lung disease, is associated with promising, although insufficient, evidence of net clinical benefit. At present, use of NIPV to facilitate weaning in mechanically ventilated patients, with predominantly chronic obstructive lung disease, is associated with promising, although insufficient, evidence of net clinical benefit.

END-OF-LIFE PALLIATIVE CARE Viable alternative for DNI/DNR patients with severe ARF Viable alternative for DNI/DNR patients with severe ARF Most commonly utilized in patients with COPD or cardiogenic pulmonary edema. Most commonly utilized in patients with COPD or cardiogenic pulmonary edema. NIPV should be applied after careful discussion of the goals of care, with explicit parameters for success and failure, by experienced personnel, and in appropriate healthcare settings. NIPV should be applied after careful discussion of the goals of care, with explicit parameters for success and failure, by experienced personnel, and in appropriate healthcare settings. Future studies are needed to evaluate the clinical outcomes and to examine the perspectives of patients, families, and clinicians on use of NPPV in these contexts. Future studies are needed to evaluate the clinical outcomes and to examine the perspectives of patients, families, and clinicians on use of NPPV in these contexts. Curtis, et al, Crit Care Med, 35:3 Perrin, et al, Rev Mal Respir, 25:10

WHAT ELSE? Tomeii (2009) Tomeii (2009) In patients with ARF of pulmonary etiologies, excluding those with recurrent aspiration pneumonia, an NIPV trial in the ED may reduce overall in-hospital mortality and ICU. In patients with ARF of pulmonary etiologies, excluding those with recurrent aspiration pneumonia, an NIPV trial in the ED may reduce overall in-hospital mortality and ICU. Tomeii et al, Respiratory Medicine, 2009, 103:1 Kenan (2000) Kenan (2000) Cost savings of $3,244 (1996, Canadian), per admission, if NIPV were adopted in favor of standard therapy. Cost savings of $3,244 (1996, Canadian), per admission, if NIPV were adopted in favor of standard therapy. From a hospital's perspective, NIPV and standard therapy for carefully selected patients with acute, severe exacerbations of COPD are more effective and less expensive than standard therapy alone. From a hospital's perspective, NIPV and standard therapy for carefully selected patients with acute, severe exacerbations of COPD are more effective and less expensive than standard therapy alone. Keenan et al, Critical Care Medicine, :6

HOW TO GET NIPV STARTED AT YHOUR HOSPITAL

THE FIRST STEPS Assess the need for NIPV in your patient population. Assess the need for NIPV in your patient population. Large COPD population? Large COPD population? Determine if NIPV is economically justified. Determine if NIPV is economically justified. Will it cost more to ventilate non-invasively than invasively? Will it cost more to ventilate non-invasively than invasively? Literature search to support NIPV in your patient population. Literature search to support NIPV in your patient population. Create a consensus among clinicians regarding the efficacy of NIPV. Create a consensus among clinicians regarding the efficacy of NIPV. Must get buy-in among those Physicians controlling your ventilators. Must get buy-in among those Physicians controlling your ventilators.

THE NEXT STEP Obtain the proper NIPV-capable ventilator and interface equipment. Obtain the proper NIPV-capable ventilator and interface equipment. Multidisciplinary leadership and training of clinicians. Multidisciplinary leadership and training of clinicians. Nursing buy-in is critical. If they don’t like masks on their patients NIPV won’t succeed. Nursing buy-in is critical. If they don’t like masks on their patients NIPV won’t succeed. Establish clinical protocols for the use of NIPV. Establish clinical protocols for the use of NIPV. Establish monitoring criteria for NIPV. Establish monitoring criteria for NIPV. Assess the outcomes of NIPV patients. Assess the outcomes of NIPV patients.

SUMMARY

NIPV SUMMARY Patient selection is critical. Patient selection is critical. Not all ARF patients are candidates for NIPV Not all ARF patients are candidates for NIPV Most of the RCTs that have studied NIPV have studied its use for the treatment of COPD exacerbation or cardiogenic pulmonary edema. Most of the RCTs that have studied NIPV have studied its use for the treatment of COPD exacerbation or cardiogenic pulmonary edema. RCT evidence is lacking or does not suggest a clear benefit in patients with asthma, pneumonia, or acute lung injury. RCT evidence is lacking or does not suggest a clear benefit in patients with asthma, pneumonia, or acute lung injury.

NIPV SUMMARY NIPV used in this select minority of ARF patients has been proven to: NIPV used in this select minority of ARF patients has been proven to: Decrease the need for invasive ventilation Decrease the need for invasive ventilation Reduce the complications associated with Invasive Ventilation Reduce the complications associated with Invasive Ventilation Reduce LOS Reduce LOS Reduce costs Reduce costs Clearly, major gaps remain in our evidence base. Clearly, major gaps remain in our evidence base.

47 QUESTIONS?