key: cord-0848855-onrhgv3x authors: Koh, Hock Peng; Shamsudin, Nurul Shaliza; Tan, Marilyn May Yeen; Mohd Pauzi, Zulsairi title: The outcomes and acceptance of pressurized metered‐dose inhaler bronchodilators with venturi mask modified spacer in the outpatient emergency department during the COVID‐19 pandemic date: 2021-03-25 journal: J Clin Pharm Ther DOI: 10.1111/jcpt.13410 sha: e6d65105d67b949bc1068c34c3eaf9e15cde1cd6 doc_id: 848855 cord_uid: onrhgv3x WHAT IS KNOWN AND OBJECTIVE: Nebulizer use has been suspended in Malaysian public health facilities due to the potential to aggravate COVID‐19 nosocomial transmission. Currently, our facility uses the pressurized metered‐dose inhaler (pMDI) bronchodilator with Venturi mask modified spacer (VMMS) in patients visiting the Emergency Department (ED) for mild to moderate exacerbation of asthma and chronic obstructive pulmonary disease (COPD). We sought to assess the outcomes and acceptance of pMDI‐VMMS in the outpatient ED of a tertiary hospital in Malaysia. METHODS: We analysed the total visits and discharge rates during periods of using the nebulizer and current pMDI‐VMMS methods. The acceptance of pMDI‐VMMS by patients and assistant medical officers (AMOs) were assessed by questionnaire. RESULTS AND DISCUSSION: We analysed 3184 ED visits and responses from 103 patients and 32 AMOs. The direct discharge rate was similar for both nebulizer (n = 2162, 92.5%) and pMDI‐VMMS method (n = 768, 90.7%) (p‐value = 0.120). Twenty‐eight patients (27.2%) favoured the pMDI‐VMMS over the nebulizer, whereas 36 patients (35.0%) had no preference for either method. Sixty‐four patients (62.1%) felt that the current pMDI‐VMMS method was better or at least as effective in relieving their symptoms as a nebulizer. The current method was favoured over the nebulizer by twenty‐seven AMOs (84.4%). Twenty‐eight (87.5%) AMOs suggested that the current method was more effective than the nebulizer. WHAT IS NEW AND CONCLUSION: The bronchodilator delivered via pMDI‐VMMS appeared to be comparable to nebulizer in treating mild to moderate asthma and COPD exacerbations in the outpatient ED. Most patients and AMOs accepted the use of pMDI‐VMMS in the outpatient ED during the current COVID‐19 pandemic. The Venturi mask modified spacer can be a cheap and effective alternative to the commercial spacer in a resource‐limited situation. The coronavirus disease 2019 has impacted global healthcare practices. The prevention of SARS-CoV-2's nosocomial transmission is vital as aerosol-generating processes (AGPs) can transmit SARS-CoV-2. 1,2 AGP is defined as any medical procedure capable of inducing the development of aerosols of various sizes, including small particles (<5 μm). 3 The high transmissibility and infectivity of SARS-CoV-2 is a concern as the virus viability in respirablesized aerosols is up to 16 h within the laboratory environment. 4 The use of nebulizer was listed as an AGP. 1, 5 Based on limited available data, the evidence of SARS-CoV-2 transmission via nebulization is inconclusive. 6 are mild or asymptomatic, where patients themselves are not aware of being infected but can infect others. 14 Besides, it is important to note that nebulizer treatment commonly induces or aggravates cough due to the lower temperature of the aerosolized liquid medications and massive dilution of sputum, which retains in the airway. 15 Any bioaerosol generated by the patients, especially during coughing, can be dispersed via nebulization. Thus, delivering medications via nebulization to patients with undiagnosed COVID-19 can potentially aggravate the spread of the SARS-CoV-2 in the healthcare facilities. The Emergency Department (ED) of Hospital Kuala Lumpur (HKL) stopped the use of nebulizers. The pMDI bronchodilator with a spacer was used after considering the risk of transmission by asymptomatic or pre-symptomatic patients, patients' non-disclosure of their contacts or symptoms, sporadic cases and limited negative pressure environment for AGPs. A study has demonstrated comparable performance between the nebulizer and pMDI with the spacer in delivering short-acting beta2-agonists in acute asthma among paediatric patients. 16 However, this finding is less certain in adults. 17 Besides, most studies involving adult patients in emergency settings used only commercial spacers. 16 In Malaysia, public healthcare facilities could not provide each patient with a commercial spacer considering the cost and stock availability in the Malaysian market due to the sudden surge in demand. Also, most commercial spacers were designed for single patient use and carry the risk of crossinfection if reused for another patient. Thus, the commercial spacer with a facemask was restricted for inpatient ED use. We initiated the use of pMDI bronchodilators with the Venturi mask modified spacer (pMDI-VMMS) in patients visiting the outpatient ED for mild to moderate asthma or COPD exacerbation. The VMMS is disposed of after every patient's use, and the pMDI bronchodilator is given to the patient during discharge to avoid cross-infection. An effective delivery method for bronchodilators is crucial to replace the use of the nebulizer temporarily. Currently, there is no study done to assess the outcomes of VMMS in delivering pMDI bronchodilators. From 30 March 2020 to 06 April 2020, a pilot survey involving 90 patients who attended ED showed encouraging 92.2% discharge rate results. Therefore, we aimed to assess the outcomes of pMDI-VMMS and the acceptance of this method by patients and assistant medical officers (AMOs) in the outpatient ED during the COVID-19 pandemic. This study is a single-centre prospective cross-sectional study con- The study's inclusion criteria were as follows: adults above 18 years old who attended ED for mild and moderate asthma or COPD exacerbations, experience of receiving nebulizer treatment of short-acting bronchodilators before the COVID-19 pandemic and fit for discharge after receiving treatment. Patients who disagreed to participate, discharged at their own risk against medical advice or did not understand Malay and English languages were excluded from the study. Patients must fulfil criteria as per ED HKL protocol before discharge, including resolution of symptoms, negative rhonchi, not tachypnoeic, SpO 2 ≥ 95% on room air, and having stable blood pressure and heart rate. In the AMOs group, only those with experience managing patients before and during the COVID-19 pandemic were recruited. The severity of COPD exacerbation was based on cardinal symptoms, including increased dyspnoea, increased sputum volume and increased sputum purulence. In mild COPD exacerbation, only one of the three cardinal symptoms is present. Two out of three cardinal symptoms are required for the diagnosis of moderate COPD. 18 Mild and moderate asthma exacerbation includes patients who can talk in phrases or full sentences, not agitated, respiratory rate below 30 breaths per minute, heart rate below 120 beats per minute and oxygen saturation above 90% on pulse oximetry, without features of severe asthma exacerbation. 19, 20 The peak expiratory flow (PEF) measurement was stopped because of aerosol generation risk. All patients with mild and moderate asthma or COPD exacerbations received the standard clinical evaluation and treatment by the AMOs using the current in-house interim protocol. Information was collected from the outpatient ED Registry, which included the date of visit, the number of visits, the number of patient identity documents (ID) or passports (for foreigners), and the visit outcome (discharged or up-triaged). Data for both nebulizer and pMDI-VMMS methods were retrieved for an equivalent period of 59 days to compare the outcomes between these two methods. During nebulizer treatment, the ED attendances were retrieved retrospectively as all nebulizer treatments were stopped during the COVID-19 pandemic. A survey was conducted via questionnaires for both patients and AMOs to assess their acceptance of pMDI-VMMS. Patients were conveniently recruited during researchers' dedicated research time from 16 May 2020 to 23 July 2020. Informed consent was obtained, and the patient information sheet was handed to patients who met the inclusion criteria, were fit for discharge and agreed to participate in the study. Recruited patients were given adequate time to complete the questionnaire for the survey. The researchers assisted patients who understood the Malay or English language but could not read due to some reasons such as visual impairment. In the patients' survey group, pertinent data including age, gender, race, underlying lung disease, clinical parameters pre-and post-treatment, and patient's outcomes were obtained from outpatient ED clerking. Clinical parameters consisted of symptoms, auscultation findings, oxygen saturation, blood pressure, heart rate and respiratory rate. Clinical parameters were collected to ensure that enrolled patients fulfilled the discharge criteria. Patient outcomes consisted of patient discharged status, types of pMDI bronchodilator used and the total cycle of pMDI received. The primary endpoints were the direct ED discharge rate and pMDI-VMMS's acceptance. The pMDI-VMMS's acceptance was as- Appendix 2 shows the questionnaires for the English edition used in this study. Convenience sampling method was used in patient recruitment. Data collected from 103 patients and 32 AMOs were analysed. The patients' median age was 56 (39.0-67.0) years, and the majority of them were male (n = 67, 65.0%). Most patients who visited outpatient ED HKL were diagnosed with asthma (n = 61, 59.2%). All patients had experience of receiving nebulizer treatment in the public healthcare facilities. A single agent, pMDI bronchodilator, salbutamol, was used in most patients (n = 100, 97.1%) ( Table 1 ). The total number of visits to outpatient ED for mild and moderate asthma or COPD exacerbations was 2338 and 846 during the nebulizer and pMDI-VMMS method, respectively, for the same duration of 59 days. The direct discharge rate was similar for both nebulizer and pMDI-VMMS methods (p-value = 0.120) ( Table 2 ). The AMOs' interview responses were summarized in Table 5 . Twenty-seven (84.4%) AMOs favoured pMDI-VMMS over nebulizer. Twenty-eight (87.5%) of AMOs feedback that pMDI-VMMS was more effective than a nebulizer in treating asthma and COPD exac- Venturi mask modified spacer was used as the alternative to the commercial spacer in our setting. To our knowledge, this is the first study reporting the outcomes of pMDI-VMMS during the COVID-19 pandemic. Research on using a modified or non-commercial spacer in adult patients during asthma or COPD exacerbation was lacking. Evidence on non-commercial spacers such as 500-ml bottles was mainly on inhaled corticosteroids for maintenance therapy for adults and the paediatric population. 21, 22 An in vitro performance study has demonstrated that the 6-inch tube (1-inch inside diameter) was as effective as commercial spacers in delivering fluticasone dipropionate metered-dose inhaler at a straight position. 23 However, several other factors were considered during the search for an alternative to the commercial spacer. These included reduced inspiratory effort and coordination during an exacerbation and patients' preference to use a face mask. The face mask and 6-inch tube from the Venturi mask set were selected as the alternative to deliver pMDI bronchodilators. The Venturi mask set is readily available in the hospital setting and costs less than 3.60 Ringgit Malaysia (0.84 US dollars). There was no significant difference in the rate of direct discharges between the pMDI-VMMS versus nebulizer among patients attending outpatient ED for mild and moderate asthma or COPD exacerbations. Thus, based on our study outcomes, pMDI-VMMS is as effective as the nebulizer. Our direct discharge rates for both bronchodilators' delivery methods were slightly higher than stated in the literature. In adult patients who visited the community and emergency settings for acute asthma exacerbation, the discharge rates for the nebulizer and pMDI with spacer methods were 89.1% and 89.7%, respectively. 17 However, patients with severe exacerbations of asthma or COPD, which were not included in our research, may be included in other studies. In our setting, less than 10% of our patients were up-triaged to inpatients ED higher acuity zones for further management after the initial four cycles of pMDI bronchodilators failed. However, not all up-triaged patients were warded. Despite the abrupt switch of the bronchodilator delivery system at outpatient ED, the use of pMDI-VMMS was accepted and preferred by the majority of the patients. However, a substantial number of patients (n = 39, 37.9%) still preferred bronchodilator administration via nebulizer, although the pMDI-VMMS successfully reversed their asthma or COPD exacerbation. These patients indicated that they felt better and more comfortable with nebulizer therapy, as there was oxygen supply. The use of pMDI-VMMS was accepted and favoured by most AMOs. As the preparation steps are much more manageable, pMDI-VMMS is less time-consuming than giving nebulizer treat- another bronchodilator delivery method other than nebulizer, there are limitations in healthcare resources, or limited availability of commercial spacers due to sudden surge in demand. Nevertheless, we note some limitations of this research. The unique setting of the current COVID-19 pandemic does not allow for a head-to-head trial of both bronchodilators' delivery methods, which will provide a more reliable comparison of the two methods' efficacy. Secondly, peak expiratory flow rate (PEFR), the objective measurement of lung function, was not carried out due to the potential risk of cross-contamination and bioaerosol production by undiagnosed pre-symptomatic or asymptomatic COVID-19 patients. We are aware that the acceptance and favouritism over a method do not necessarily translate into better treatment outcomes. Lastly, this study involved only patients fit for discharge. Patients (less than 10%) that have been up-triaged to higher acuity inpatients ED zones for further management may have a different opinion. The bronchodilator delivered via pMDI-VMMS was comparable to a nebulizer in treating mild to moderate asthma and COPD exacerbations in the outpatient ED. Most patients and AMOs accepted the use of pMDI-VMMS in the outpatient ED during the current COVID-19 pandemic. In healthcare facilities treating mild to moderate asthma and COPD exacerbations, pMDI-VMMS can be an alternative to the nebulizer to minimize aerosol-generating procedures. The Venturi mask modified spacer can be a cheap and effective alternative to the commercial spacer in resource-limited situation during COVID-19 pandemic. However, further study on the pMDI drug delivery via VMMS and lung function is needed to ascertain this delivery method's clinical efficacy. We would like to thank the Director-General of Health Malaysia for his permission to publish this article. We also like to thank Dr Mahathar Abd Wahab, Head of Emergency Department, and Dr Lumpur, for critically reviewing this manuscript. The authors declare that they have no conflict of interests. Accessed November 2, 2020. 2. COVID-19 Guidance for the Remobilisation of Services within Health and Care Settings. 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The outcomes and acceptance of pressurized metered-dose inhaler bronchodilators with venturi mask modified spacer in the outpatient emergency department during the COVID-19 pandemic Survey questionnaire. Are you on regular follow-up in the hospital/clinic for your lung disease?Yes/No Do you have any experience of receiving nebuliser in the emergency department to relieve the attack of your lung disease? In your opinion, which method is better in relieving your symptoms?pMDI with venturi mask/nebuliser/same In your opinion, which method is easier to use? pMDI with venturi mask/nebuliser/same The