S. Aiolfi , V. Patruno, G. Beghi, L. Chiesa, U. Zorza, M. Rota Pulmonary Rehabilitation Unit

1. Dublin May 18th – 20th 2005 Health plans for COPD patients undergoing home non-invasive mechanical ventilation (HNIMV): from hospital to home. S. Aiolfi, V. Patruno, G. Beghi, L. Chiesa, U. Zorza, M. Rota Pulmonary Rehabilitation Unit A.O. “Ospedale Maggiore” - Crema - Italy

2. Background • The prevalence and impact on public health of chronic obstructive pulmonary disease (COPD) are rising. • Individuals living with COPD require skills and information necessary to make changes in their behaviour in order to stay healthy and avoid further deteriorations.

3. Ischemic heart disease Cerebrovascular disease Lower respiratory infection Diarroheal disease Perinatal disorders COPD Tuberculosis Measles Road traffic accidents Lung cancer 1 1 2 2 3 3 4 4 5 5 6 6 7 7 8 8 Kstomach 9 9 HIV 10 10 suicide PROJECTED CHANGES IN WORLD-WIDE MORTALITY 1990-2020 WHO Global Burden of disease study

4. Stage 0: At Risk Stage I: Mild COPD Stage II: Moderate COPD Stage III: Severe COPD Stage IV: Very Severe COPD Lung function is still normal FEV1/FVC < 70% but FEV1 ≥ 80% predicted) 50% ≤ FEV1 < 80% predicted 30% ≤ FEV1 < 50% predicted Exacerbations of symptoms, which have an impact on a patient’s QoL FEV1 < 30% predicted or FEV1 < 50% predicted plus CRF Classification of COPD(GOLD 2003)

5. NON INVASIVE VENTILATION • Non-invasive ventilation (NIV) is gaining increasing popularity after good evidence has shown that • not only patients with decompensated, hypercapnic COPD, • but also patients with acute respiratory failure may benefit from the early institution of non invasive positive pressure ventilation (NPPV). Mehta S., Hill NS. Non invasive Ventilation. State of the Art. Am J Respir Crit Care Med 2001; 163: 540-577

6. Goals of NIMV • To keep under control the evolution of CRF • To increase quality of life: reduction No. and severity of exacerbations; • To increase social and physical function and quality of sleep; • To slow the progression of the underlying disease • To reduce morbidity and increase survival; • To reduce health costs of these patients. Hill N, Leger P, Criner G.: Consensus conference report. Chest. 1999;116:521-534

7. Aim of our study • To report our experience on patients suffering from COPD Stage III & IV associated with chronic respiratory failure (CRF), dismissed from our Unit in Non-Invasive Mechanical Ventilation after an in-hospital management approach • To verify if our multidisciplinary intervention would have resulted in a better compliance to the prescribe therapy regimen

8. DEMOGRAPHICS • 48 COPD patients, stage III / IV with Hypercapnic CRF • April ‘99 - December ‘04 • M/F ratio 1,4:1 • Mean age 62 years

9. Smoking history: Ex-smokers Non-smokers Arterial blood gases: pH - pO2 -PCO2 Vital Parameters Blood Pressure Heart Rate Respiratory rate PFT FEV1 pre – post bronchodilator FVC - FRC (He) DLCO MIP - MEP Dyspnea index Borg’s scale VAS Exercise test Walking test Cycloergometer test Patients assessment - 1

10. Nocturnal Pulsoxymetry Full night Cardiorespiratory monitoring or Polysomnography Choosing the ventilator Choosing the best interface Setting the ventilator to the correct parameters: IPAP – EPAP values Rise time I/E ratio Back up R.R. Fixing FiO2(when needed) Patients assessment - 2

11. Choice of ventilator and setting • An individualized approach to the choice of ventilator and ventilator setting for each patient is mandatory. • The ventilator type should be determined by each patient’s degree of comfort, coupled with the ability to increase minute ventilation, improve gas exchange, and diminish the work of breathing.

12. Interfaces in NIMV • The interface between patient and ventilator is a crucial issue • An uncomfortable mask may be the reason to refuse NIMV and its inappropriate fitting may cause a reduction in its efficacy • Proper sizing and fitting of the mask may require several attempts owing to the facial architecture

13. Spectrum of interfaces in NIMV • Approximately 15–20 types of commercial or custom-made nasal and face masks are on the market. • Both nasal and facial masks show advantages and disadvantages.

14. Advantages & disadvantages of masks

15. Mask leak Mouth leak The ventilator itself cannot distinguish mask leak and/or mouth leak Both types of leak and their deleterious effects tend to go unrecognised (i.e. complete loss of supplemental O2) Main problems with NIMV

16. Mask Leak • can be highly irritating to the patient or cause conjunctivitis • high leak can produce a reduction of pressure delivered • headgear needs to be regularly inspected and replaced when overstretched • If a leak is intractable, another size or style of mask should be tried

17. Mouth leak • Can lead to severe nasal symptoms with burning, drying, rhinorrhoea, and congestion which in turn lead to increased nasal resistance and causes severe sleep fragmentation. • Mouth leak can lead to a loss of 50% of effective pressure delivered. • A chin strap may help reduce mouth leak, but typically only reduces it by some 50%.

18. Side-effects of NIMV The commonest are due to: • The interface: nose and face mask • Aerophagia • Nasal dryness/congestion or bleeding and dry mouth in the morning • Conjunctivitis

19. Side-effects • A poorly fitting mask can produce not only discomfort but severe pain with: • redness • abrasion • ulceration of the bridge of the nose • Aerophagia: High pressures (> 20 cmH2O) will result in the stomach filling with air, which is unpleasant and increases the elastic work of breathing, thereby leading to higher pressures being delivered.

20. Side-effects: Nose – Mouth - Eyes • Nasal dryness/congestion or bleeding and dry mouth in the morning are largely symptoms of mouth leak, which also severely impair delivery of effective therapy. • Conjunctivitis: is due to mask leak, and should be treated with a change in mask size, fitting, style, or headgear.

21. Humidification Drying of the nasal mucosa, rhinorrhoea, congestion, and increased nasal resistance can be prevented by humidification: • a cold humidification increases the relative humidity by only 6–9% and has scarce effects on the above symptoms • a hot water bath humidifier increases the relative humidity to 97% and does eliminate symptoms and abolish nasal resistance

22. Empowering patients and their caregivers

23. Educational Sessions Together with their caregivers, all patients attended multi-disciplinary personalized, and group educational sessions and training on: • home management of their condition • how to handle and to clean their ventilator, tubes, mask, and oxygen supplier • how to keep a diary of their condition (symptoms and signs) and malfunctioning of their devices

24. NIMV at Home: what to consider • A domiciliary plan for routine servicing/cleaning and preventive maintenance schedule • Once home, patients will be contacted during the first week, and later periodically, in order to check the ventilator for proper functioning • The home-care company should perform preventive maintenance, and must guarantee a 24-h technical service consisting of • inspection of the ventilator • replacement of tubing, mask, and filters

25. Going home: the discharge planning A follow up schedule was set at 1, 3, 6 months, and subsequently every 6 months, if no exacerbations, consisting in: • Clinical visit • BGA • Educational reinforcement sessions • Monitoring of: • Compliance • Requests of technical support; • Non scheduled visit or ER visits; • Admissions to hospital.

26. Compliance • Compliance is very high in end-stage COPD pts who are ventilator dependent, but can be very disappointing in patients with obesity-hypoventilation syndrome or hypercapnic CRF at earlier stages. • A ventilator should have an hour-meter, so that compliance can be monitored, particularly during the first weeks of therapy.

27. Compliance • A recent paper investigated the efficacy and compliance with long-term NIMV in 40 patients with CRF. • After initial evaluation, 34 patients received NIMV via PTV (i.e. BiPAP) and only six patients via VTV. • During the 6 months follow-up 14 patients discontinued NIMV due to poor compliance. In the compliant patients blood gases and functional status improved in the long term. Criner GJ, Brennan K, Travaline JM, Kreimer D. Chest 1999; 116: 667–675.

28. Low compliance Identify the causes Educate the patient and family Decreased compliance can be due to: Poor mask fitting Mouth leaks Mask leaks Ventilator noise Claustrophobia Poor patient-ventilator synchronization Compliance

29. Our Results • All 48 pts attended the scheduled follow up controls. • To date, 7 pts had died: 4 M, 3 F • Compliance to treatment: good  > 85% time prescribed • Routine servicing/cleaning and preventative maintenance schedule: good  performed by caregivers • Requests of technical assistance = 107% than scheduled • Non scheduled visit (E.R./Respiratory Clinics) = 104% • Hospital readmissions for respiratory problems: mean 0.8/year for each patient

30. Pneumologist Specialized Nurse Respiratory Therapist Patient & caregivers PFT’s Technician Psychologist + Home assistance network Primary Care Physician Dietitian Consultants Specialists Pulmonary Rehabilitation TEAM

31. Conclusions Our multidisciplinary approach to patients in HNIMV, based on holistic system care, shows • good compliance to treatment • low hospital readmission ratio • low emergency visit requests Globally, good patient’s and caregivers’ satisfaction as a consequence of a good health educational approach during hospital stay and at follow up and a good management of their condition at home.

32. S. Martha’s Team Thank you all !!