Operation Manual for clinical use of SIARE Pulsar

Operation Manual for clinical use of SIARE Pulsar This manual is for clinical use only 1-12

INDEX 1) Indications /Contraindications and cautions 2) Questions to ask before using a MI-E machine 3) Guideline for PULSAR setting What to do Before starting During use After use 4) Special Considerations Use of Pulsar in acute context Use of Pulsar in chronic context Use of Pulsar in Paediatric context 5) Possible side effects 6) Frequent Questions 1. Which are the correct settings? 2. Can Pulsar be used on patients with bulbar problems? 3. Can patients with learning difficulties use Pulsar? 4. How many times a day should Pulsar be used? 5. How long does it take for a treatment session with Pulsar? 6. Can Pulsar be used in presence of secretions? 7. Can Pulsar be used if the patient had a pneumothorax? 8. Which are the contraindications for Pulsar? 9. Can the same Pulsar be used with different patients? 10. Can Pulsar be used with newborns? 11. Can I use Pulsar with a mouthpiece? 2-12

Introduction Cough is an important mechanism to eliminate exceeding secretions and foreign bodies from airways. In patients with airways intrinsic diseases or with respiratory muscles weakness, the ineffective cough is one of the main cause of mortality and disease, since it can close lungs areas to the inspiratory flows, due to the formation of thick mucus plugs obstructing the small and medium airways and causing repeated bronchitis and bronchopneumonia. Cough stimulation techniques are used in patients presenting weak or ineffective cough: the scope of these techniques is to increase the cough flow, by assisted inspiration and /or expiration, improving the cough effectiveness. When the conventional physiotherapy techniques of assistance for secretions removal are ineffective, the cough stimulator (Pulsar) should be considered. Action mechanism of cough stimulator. The mechanism at the base of the device is the simulation of a cough act with prior delivery of a positive pressure (inflation phase) and, in rapid sequence, a negative pressure (exufflation phase). The inspiration of air volumes is to make up for a deficiency of 1 st phase of the cough (increase of pre-tussive Volume). The acceleration in the expiratory phase with a negative pressure is to facilitate the lack of the 3 rd phase of the cough (secretions expulsion). The 2 nd phase of the cough (i.e. that of glottis closure, which is necessary to increase the intra-thoracic pressures) is compensated by the increase of kinetic force acquired by the chest wall during inspiration, thanks to the acceleration caused by the negative pressure during expiration. 1) Indications /Contraindications 1. Weakness of respiratory muscles, with ineffective cough [Peak of cough flow (PCF) < 270 l/min.] 2. Maximum Expiratory Pressure (MEP) < 40 cm H2O 3. In case of ineffectiveness of the air stacking. manoeuvres (insufflations of air bolus with ambu bag or ventilator) and consequent rapid exsufflation with or without thoracic compression. 4 In particular in all conditions of neuromuscular impairment. The relative contraindications are: o Recent barotrauma o Pneumothorax or Pneumomediastinium o Bullous emphysema o Recent thoracic and abdominal surgery o Epitasis or haemoptysis o Homodynamic instability o Maxillofacial trauma 3-12

2) Questions to ask before using Pulsar BEFORE STARTING 1) Does the patient s disease matchs the clinical indications? Follow this outline: - Does he present a neuromuscular disease (NMD), congenital or acquired? - Does he present a PCF under 270 L/min? - Does the patient present secretion at auscultation? 2) Are there any contraindications for the use of the cough device? Keep on mind the table of the previous paragraph. 3) Have you been trained on Pulsar use, and do you feel confident in its application? Do you know how to access and turn-off the device? Have you been trained to apply the catheter mount to the tracheotomy cannula or to the mask? Do you know how to set Pulsar? Did you study the application protocols? Have you been trained to monitor the haemoglobin saturation by pulse oximeter? Have you been trained on aspirator and ambu use? 4) Since the Pulsar application can mobilize a large quantity of secretions and cause their accumulation in the central airways and then the temporary obstruction of the same, are you equipped with emergency kit (oxygen, ambu and resuscitation kit) and aspirator? Did you check their efficiency and functionality? 5) Is there the possibility to connect the patient to Pulsar in a correct way? - Have you masks of different sizes?have you the suitable mask or kit for tracheal cannula connection? 6) Are you using the antibacterial filter? 4-12

3) Guideline to PULSAR setting Before starting Verify the functionality of Pulsar: 1) Connect it to the main power supply. 2) Connect the double hose, position the filter to the Y connection 3) Choose the most suitable mask and place it at the Y connection. If the patient has a tracheostomy tube, insert a catheter mount. 4) Position the cough stimulator on a rigid surface without underlying sheets or covers (the Pulsar aspire air from his base) because they could impede the ambient air collection affecting the functioning. 5) Verify the pressure and flow test as indicated in the operation manual. 6) Set initially the manual mode. 7) Set low pressure of In-Ex (+/- 10-15 cmh2o). 8) Set the patient, possibly in sitting position, (in his chair or on the bed placed at 45 ). 9) It is important, during the treatment that: The patient head is well fixed (lying on the rear head restraint or held with a hand by therapist or caregiver) The mask does not allow air leaks and it is close to the face If a mouthpiece is used, also use a nose clamp In case of tracheotomy: cuff the cannula 10) By using the manual remote control (supplied with the device) stay beside the patient. If the patient cannot correctly manage the mask himself, keep it in plece with your hands placing behind the patient and use the foot remote control (optional accessory). 5-12

During the use 1) Explain in a concise and clear way the treatment to the patient. 2) The therapist (or the caregiver) must explain to the patient how to be coordinated during the insufflations and exsufflation manoeuvres (e.g. keep the air in! means insufflations and then the patient inspiration throw off the air! means exsufflation and then the patient expiration) 3) The insufflations manoeuvre must be kept for more than two seconds (2-6 sec) until reaching the pressure set (since the Pulsar has a smoother insufflations and exsufflation curves, it is necessary to keep for longer times than those used with other cough machines) 4) The full treatment is composed of 4-6 cycles of in-exsufflation, with pauses of 20-30 sec to avoid the patient hyperventilation. 5) The pressure standards and the time of use are different from one study to another and not all the authors give precise indications on the parameter s setting. Normally, pressures set are higher than 30 cmh2o, on average 40-45 cmh2o). 6) The titration of pressure and inspiratory time is, anyhow, based on tolerance and real thoracic capacity of the patient. 7) The inspiratory time is usually longer than expiratory time as much as the inspiratory pressures are higher than expiratory ones. (To facilitate as much as possible the passive recoil and prevent the collapse of airways in expiratory phase) 8) Some therapists make various insufflations, take a pause between inspiration and expiration then proceed with exsufflation. Usually, between inspiration and expiration there is no pause. 9) Always monitor Cardiac Rate and Hb Saturation with pulse oxymeter. 10) If the patient cannot spit out the mucus, help him possibly with an aspirator, through the nose, the mouth or tracheotomy tube. Special Functions If the patient does not cooperate, it is suggested, after adaptation, to change modality from manual to trigger mode (ASSIST), which allows a better synchronization of insufflations with inspiratory phase of the patient. Otherwise, if the patient cannot perform spontaneous acts it is suggested to use the automatic modality (AUT). If the patient is fully cooperating and thus he is perfectly synchronised with the device phases, it is possible to make the operator s work easier thanks to the automatic modality. After use Turn-off the device as indicated in the manual Check the circuit: if secretions obstruct it, replace it. 6-12

If the patient uses an oral-nasal mask, clean the mask with mild soap and water. INITIAL TITRATION The device can be used in manual or automatic modality. Initially, the device is set in manual modality with an oral-nasal mask or catheter mount (tracheotomy); this guarantees the maximum comfort for the patient. The device is often switched in automatic modality, which allows it to be used at home without any practitioner. First it is necessary to monitor the oxygen saturation, specially during an acute event (theoretically, it should be used whenever Pulsar is used) Start insufflations (positive pressure) with pressure at 10-15 cm H2O (1.0 1.5 kpa), then gradually increase it until having an inspiration at total lung capacity. It is possible to require a positive pressure over 40 cm H2O (3,9 kpa); (the delivered pressure can be limited by lifting the mask from the face). The insufflations time should still be higher than 2 sec. Start exsufflation (negative) with a pressure equal to the insufflation s one, and then increase the positive pressure of 10-20 cm H2O (1.0-2.0 kpa) respect to negative pressure. The positive pressure is then maintained for 3-6 s, simulating the air flows that naturally occur during the cough. The best indicator of effectiveness is an increase of the cough sound: then it is recommended to listen carefully the noise of patient flow in the expiratory phase. Often, the patient can independently assess the effectiveness of the cough. The patient must learn to synchronise his acts when the device switches from insufflation to exsufflation. 4) Special Considerations Use of Pulsar in acute context Some authors [1] compared 11 patients with neuromuscular diseases who have received an average of ± DS 2,7 ± 0,9 sessions of MI-E per day combined with 16 historical checks, who have been treated with postural drainage, manual assisted cough and aspiration when needed. The results of the retrospective study demonstrated that the patients who received MI-E had a rate of treatment failure (defined by the need to insert a mini-tracheotomy or intubations) of 18 vs 62,5%, p = 0,047. There was no significant difference between the two groups in the proportion of patients who need non-invasive ventilation at positive pressure (NIPPV, p = 0,37) or intravenous antibiotics (p = 0.25), in the duration of NIPPV (p = 0.93) or in the proportion of patients who needs bronchoscopy (p = 0,71). The study of J. Sancho et al. conducted on tracheotomized patients affected by SLA, compares the tracheo-aspiration to the use of MI-E: the use of mechanic removal of secretions is more effective both to facilitate the oxygenation and to decrease the airways resistance (18). The use of NIPPV combined with MI-E during exacerbation, how observed by J. Bach, can reduce the number and duration of hospital admissions (17). Miske reports the effectiveness of MI-E in the resolution of atelectasis, reiterating the importance of its use in critical conditions. (6). 7-12

Use of Pulsar in a chronic context Some authors (16-17) believe that the use of MI-E is extremely effective in acuity but its use alone not always guarantees the complete secretions removal, therefore the regular daily use of MI-E, also in absence of secretions allows maintaining the adaptation and an optimal use in case of exacerbation. It should be also empathized that the MI-E not only covers the expectoration with assistance, but it is also a support for maintaining the lung compliance, which is a fundamental for cough enhancement manoeuvres (16). Therefore, Pulsar besides to be a cough stimulator, for its intrinsic characteristics, can be used in absence of exacerbation for : o maintaining and increasing the elasticity of the rib cage o facilitating the recruitment of peripheral airways o maintaining a degree of skill in the use of the machine Then, we would like to conclude that in cases where there is a pathophysiology (PCV, VC, MEP) and clinical indication, the MI-E should be used, in critical periods, for secretions removal, while in the period of stability, like an instrument for maintaining lung elasticity. The use of Pulsar in Paediatric context Pulsar can be used in paediatrics. The age is not a contraindication, there are also some literature cases describing treatments on newborns patients. The titration technique is the same as for the adult: initially low pressures have to be preferred then gradually increased until the target pressure is reached (2.6). 5) Possible side effects of Pulsar use 1) In some patients (specially paediatrics) heart rate might increase as well as the blood pressure (both systolic and diastolic) and an the cardiac output (2). It was seldom observed bradycardia in case of myelopathy with spinal shock and in some paediatric patients with SMA: in such cases it is important to increase the pressures gradually; a pre-medication with anti-cholinergic drugs could help. 2) Some patients could feel chest pain because of stretching of the muscle-skeletal structures, in particular on those with severe thoracic deformities. This can be prevented by gradual increases in pressures. 3) Gastric and abdominal distension; nausea and vomiting could occur: the gastric distension can be solved with the reduction of pressure level. In some cases there was the increase in gastric pressure due to the concomitant use of abdominal thrust. (3). Some authors report the presence of a Gastro-esophageal Reflux, therefore its use is recommended before meals (1) 4) Have been described cases of pneumothorax associated with the daily use of MI-E in tetraplegic patients with C4 injury and with Duchenne Dystrophy (4). Nevertheless, in a wide study, Barach and Beck have not detected a barotrauma in over 2000 applications and 103 patients treated with MI-E (5). 5) It may appear an early and transient de-saturation due to a secretion encumbrance in the upper airways (6) caused by the central displacement of secretions. Pulsar, in case of need, allows the safe use of over 21% O2 mixtures. 8-12

6) Blood traces can be noted in the secretions due to their detachment from the bronchial walls to which they are tenaciously adherent. 6) FAQ 1. Which are the correct settings? The settings vary from patient to patient. The parameters definition and settings is independent from underlying disease. A study of Winck compares the effectiveness of different insufflation and exsufflation pressures (15, 30, 40 cm H 2 O) on the PCF value and on tolerance (7). In particular, the PCF, in patients affected by SLA and COPD increases only using pressures of +/- 40 cm H 2 0. Some authors report the use of lower pressures: Chatwin (8) applies positive pressure of 15 +/- 3 cm H 2 O and negative pressures of 15 +/- 9 cm H 2 O but the PCF increment, although significant, remains lower than that obtained by Bach (9) who uses higher pressures. Other authors (Sivasothy and oth.) used pressures of +/- 20 cmh 2 O (10). The guidelines of the American College of Chest Physicians Consensus statement for muscular atrophy, dated 2009, report a protocol for the treatment of the patients affected by Spinal Muscular Amyotrophy (SMA): they indicate pressure of at least 30 cm H 2 O, defining as ideal the pressures over 40 cm H 2 O. (11). The mechanical in-exsufflation can be upgraded in its functions by coupling methods: one of the most common is the abdominal thrust. 2. Can the Pulsar be used on patients with bulbar problems? Keep in mind that in case of complete paralysis of the glottic function, there is the risk of airways collapse in expiratory phase (12). Such a phenomenon can be explained by the fact that normally the application of a negative pressure at the mouth at the end of an expiration determines the stretching and the activation of the genioglossus, dilator muscle of the pharynx. Such a phenomenon is finalized to keep the airways open (13, 14). In patients with injury to oropharingeal muscles, the genioglossus cannot oppose to the closure of the high airways therefore MI-E generates an expiratory collapse that prevents the PCF increase also in presence of an adequate lung compliance. 3. Can patients with learning difficulties use the Pulsar? In patients with the competent glottic and cognitive functions to follow the inspiratory and expiratory phases, the patient compliance can be a key factor. Pulsar can be used effectively in patient with learning difficulties. In manual or automatic phases the adapting time can be extended. To facilitate the adaptation of the patient it has been introduced in Pulsar the inspiratory trigger for coupling the acts of the patient with those of the machine. 4. How many times a day should Pulsar be used? Concerning the number of daily sessions there is a certain variability among Authors. Bach recommend a very frequent use of MI-E (from 2 up to 4 times per hour) in presence of abundant secretions (15, 16) while other authors recur at a very much lower frequency of application (17). 5. How long does it take for a treatment session with Pulsar? The complete treatment consists in 4-6 cycles of in-exsufflations, with pauses of 20-30 seconds to prevent the patient hyperventilation. Pressure standards and application times are different from one study to another and not all the Authors give precise indications on parameter s setting principle. Normally the duration of the treatment is around 20-30 min repeated several times a day (minimum twice a day). 9-12

6. Should Pulsar be used in absence of secretions? Miske reports on effectiveness of MI-E in resolution of atelectasis confirming the importance of its use in critical conditions (6). On the other hand the patients treated only in occasion of bronchial exacerbation are the ones that fit worse to the cough mechanical support, therefore the regular use of MI-E, also in absence of secretions, permits to maintain the adaptation and optimal use in case of exacerbation. Then it should be emphasized that the MI-E is not only covering the cough assistance, but it is also a valid support for maintaining the lung compliance. 7. Can Pulsar be used if the patient had a pneumothorax (PNX)? Pulsar is contraindicated if the patient with pneumothorax has not a proper drainage. If the patient had a PNX in the past that was solved, the cough machine must be used with caution. If the patient has a PNX with a drainage on site, a decision should be taken by the physicians, considering the relation between risk and benefit, keeping in mind that negative and positive pressures can worsen the air leaks. 8. What are the contraindications for Pulsar use? It should not be used on patients with uncontrolled asthma or with bronchospasm. It should be always considered that wheezing can be caused by the presence of secretions, and for this reason the patient conditions must be evaluated very well under the clinical point of view. It should not be used on hypotensive patients or with significant hemoptysis. The list here below refers to the table 1 where there are also the relative contraindications - Recent barotrauma - Pneumothorax or Pneumomediastinum - Bollous Emphysema - Recent thoracic or abdominal surgery - Epistaxis or hemoptysis - Hemodynamic instability - Maxillofacial trauma 9. Can the same Pulsar be used with different patients? It is necessary to clean the machine between a patient and the other; in particular, each patient should have his own circuit, and the setting should be re-evaluated before starting the treatment. An high efficiency antibacterial filter should be positioned between the machine and the patient circuit. When introducing again the machine in sterile or clean areas it is necessary to respect the guidelines of the health department where the machine is to be used. 10. Can the Pulsar be used on newborns? The Pulsar, can be used on newborns. There are clinical experiences indicating the use of inexsufflators on three month old newborns. A special attention should be paid considering that newborns have a limited collateral ventilation very next to their physiological closing volume; consequently it is necessary to start with low pressures. When using the cough stimulator, initially the patient does not necessarily stop using nasal aspiration. 11. Can the Pulsar be used with a mouthpiece? The Pulsar can be used with a mouthpiece. Anyway, when the patient coughs and open the mouth, the good airtight could be lost and there could be a pressure fall during exsufflation phase. 10-12

Bibliography 1)VianelloA,CorradoA,ArcaroG,etal.Mechanicalinsufflation exsufflation improves outcomes for neuromuscular disease patients with respiratory tract infections. Am J Phys Med Rehabil 2005; 84: 83 88. 2) Miske JL, Hickey ME, Kolb MS, Weiner JD and Panitch BH. Use of the Mechanical In-Exufflator in Pediatric Patients With Neuromuscular Disease and Impaired Cough. Chest 2004; 125:1406-1412. 3) Mustfa N, et al. Cough augmentation in amyotrophic lateral sclerosis. Neurology 2003; 61:1285-1287. 4)Suri P, Burns SP, Bach JR: Pneumothorax associated with mechanical insufflation exsufflation and related factors. Am J Phys Med Rehabil 2008;87:951 955.), 5) Barach AL, Beck G.S. Exsufflation with negative pressure: physiologic and clinical studies in poliomyelitis, bronchial asthma, pulmonary emphysema and bronchiectasis. Arch Intern Med 1954; 93: 825-41 6) Miske JL, Hickey ME, Kolb MS, Weiner JD and Panitch BH. Use of the Mechanical In-Exufflator in Pediatric Patients With Neuromuscular Disease and Impaired Cough. Chest 2004; 125:1406-1412 7) Winck JC, Goncalves MR, Lourenco C, Viana P, Almeida J, Bach JR. Effects of mechanical insufflation/exsufflation on respiratory parameters for patients with chronich airway secretion encumbrance. Chest 2004; 126(3):774-780 8) Chatwin M, Ross E, Hart N, Nickol AH, Polkey MI, Simonds AK. Cough augmentation with mechanical insufflation/exsufflation in patients with neuromuscular weakness. Eur Resp J 2003; 21:502-508 9) Bach JR. Mechanical Insufflation-Exsufflation Comparison of Peak Expiratory Flows With Manually Assisted and Unassisted Coughing Techniques. Chest 1993; 104:1553-1562. 10) Sivasothy P, Brown L, Smith IE, Shneerson JM. Effects of manually assisted cough and mechanical insufflation on cough flow of normal subjects, patients with chronic obstructive pulmonary disease (COPD), and patients with respiratory muscle weakness. Thorax 2001; 56:438-444. 11) Shroth MK. Special consideration in the respiratory management of spinal muscular atrophy. Pediatrics 2009;123:s245-s249 12) Sancho J, Servera E, Diaz J and Marin J. Efficacy of mechanical Insufflation-Exsufflation in Medically Stable Patients With Amyotrophic Lateral Sclerosis. Chest 2004; 125:1400-1405. 13) Tantucci C, Mehiri S, Similowski AT, Arnulf I, Zelter M, Derenne JP, Milic-Emili J. Application of negative expiratory pressure during expiration and activity of genioglossus in humans. J Appl Physiol 1998; 84:1076-82. 14) Younes M, Sanii R, Patrick W, Marantz S, Webster K. An approach to the study of upper airway function in humans. J Appl Physiol 1994; 77:1383-1394. 15) McKim D, LeBlanc C, Walker K, Liteplo J. Respiratory care protocols for spinal cord injuries and neuromuscular diseases. Institute for Rehabilitation research and Development 2002; http://www.irrd.ca/education. 16). Bach JR. Mechanical insufflation/exsufflation: has it come of age? Eur Respir J 2003; 21(3):385 386. 17). Bach JR, Ishikawa Y, Kim H. Prevention of pulmonary morbidity for patients with Duchenne muscular dystrophy. Chest 1997; 112:1024-1028. 18. Sancho J, Servera E, Vergara P, Marin J. Mechanical insufflation-exsufflation vs tracheal suctioning via tracheostomy tubes for patients with amyotrophic lateral sclerosis: a pilot study. Am J Phys Med Rehabil 2003; 82(10) 19. Kang SW, Bach JR. Maximum Insufflation Capacity. Chest 2000; 118:61-65. 11-12

GLOSSARY BPCO : Chronic obstructive pulmonary disease DMD : Duchenne muscular dystrophy MEP : Max.Expiratory Pressure MIC: Max Inspiratory Capacity MI-E : Mechanical insufflation exsufflation MNM : Neuromuscular disease PCF : Peak of cough flow SLA : Amyotrophic lateral sclerosis SMA : spinal muscular atrophy. VC : Vital capacity VMNI : Non Invasive Mechanical Ventilation 12-12