Bubble-PAPR: a phase 1 clinical evaluation of the comfort and perception of a prototype powered air-purifying respirator for use by healthcare workers in an acute hospital setting.

OBJECTIVES: We aimed to design and produce a low-cost, ergonomic, hood-integrated powered air-purifying respirator (Bubble-PAPR) for pandemic healthcare use, offering optimal and equitable protection to all staff. We hypothesised that participants would rate Bubble-PAPR more highly than current filtering face piece (FFP3) face mask respiratory protective equipment (RPE) in the domains of comfort, perceived safety and communication. DESIGN: Rapid design and evaluation cycles occurred based on the identified user needs. We conducted diary card and focus group exercises to identify relevant tasks requiring RPE. Lab-based safety standards established against British Standard BS-EN-12941 and EU2016/425 covering materials; inward particulate leakage; breathing resistance; clean air filtration and supply; carbon dioxide elimination; exhalation means and electrical safety. Questionnaire-based usability data from participating front-line healthcare staff before (usual RPE) and after using Bubble-PAPR. SETTING: Overseen by a trial safety committee, evaluation progressed sequentially through laboratory, simulated, low-risk, then high-risk clinical environments of a single tertiary National Health Service hospital. PARTICIPANTS: 15 staff completed diary cards and focus groups. 91 staff from a range of clinical and non-clinical roles completed the study, wearing Bubble-PAPR for a median of 45 min (IQR 30-80 (15-120)). Participants self-reported a range of heights (mean 1.7 m (SD 0.1, range 1.5-2.0)), weights (72.4 kg (16.0, 47-127)) and body mass indices (25.3 (4.7, 16.7-42.9)). OUTCOME MEASURES: Preuse particulometer 'fit testing' and evaluation against standards by an independent biomedical engineer.Primary:Perceived comfort (Likert scale).Secondary: Perceived safety, communication. RESULTS: Mean fit factor 16 961 (10 participants). Bubble-PAPR mean comfort score 5.64 (SD 1.55) vs usual FFP3 2.96 (1.44) (mean difference 2.68 (95% CI 2.23 to 3.14, p<0.001). Secondary outcomes, Bubble-PAPR mean (SD) versus FFP3 mean (SD), (mean difference (95% CI)) were: how safe do you feel? 6.2 (0.9) vs 5.4 (1.0), (0.73 (0.45 to 0.99)); speaking to other staff 7.5 (2.4) vs 5.1 (2.4), (2.38 (1.66 to 3.11)); heard by other staff 7.1 (2.3) vs 4.9 (2.3), (2.16 (1.45 to 2.88)); speaking to patients 7.8 (2.1) vs 4.8 (2.4), (2.99 (2.36 to 3.62)); heard by patients 7.4 (2.4) vs 4.7 (2.5), (2.7 (1.97 to 3.43)); all p<0.01. CONCLUSIONS: Bubble-PAPR achieved its primary purpose of keeping staff safe from airborne particulate material while improving comfort and the user experience when compared with usual FFP3 masks. The design and development of Bubble-PAPR were conducted using a careful evaluation strategy addressing key regulatory and safety steps. TRIAL REGISTRATION NUMBER: NCT04681365.

Implementation of an evidence-based accidental tracheostomy dislodgement bundle in a community hospital critical care unit.

BACKGROUND: Tracheostomy dislodgment can lead to catastrophic neurological injury or death. A fresh tracheostomy amplifies the risk of such events, where an immature tract predisposes to false passage. Unfortunately, few resources exist to prepare healthcare professionals to manage this airway emergency. AIM: To create and implement an accidental tracheostomy dislodgement (ATD) bundle to improve knowledge and comfort when responding to ATD. MATERIALS & METHODS: A multidisciplinary team with expertise in tracheostomy developed a 3-part ATD bundle including (1) Tracheostomy Dislodgement Algorithm, (2) Head of Bed Tracheostomy Communication Tool and (3) Emergency Tracheostomy Kit. The team tested the bundle during the COVID-19 pandemic in a community hospital critical care unit with the engagement of nurses and Respiratory Care Practitioners. Baseline and post-implementation knowledge and comfort levels were measured using Dorton's Tracheotomy Education Self-Assessment Questionnaire, and adherence to protocol was assessed. Reporting follows the revised Standards for Quality Improvement Reporting Excellence (SQUIRE). RESULTS: Twenty-four participants completed pre-test and post-test questionnaires. The median knowledge score on the Likert scale increased from 4.0 (IQR = 1.0) pre-test to 5.0 (IQR = 1.0) post-test. The median comfort level score increased from 38.0 (IQR = 7.0) pre-test to 40.0 (IQR = 5.0) post-test). In patient rooms, adherence was 100% for the Head of Bed Tracheostomy Communication Tool and Emergency Tracheostomy Kit. The adherence rate for using the Dislodgement Algorithm was 55% in ICU and 40% in SCU. DISCUSSION: This study addresses the void of tracheostomy research conducted in local community hospitals. The improvement in knowledge and comfort in managing ATD is reassuring, given the knowledge gap among practitioners demonstrated in prior literature. The ATD bundle assessed in this study represents a streamlined approach for bedside clinicians - definitive management of ATD should adhere to comprehensive multidisciplinary guidelines. CONCLUSIONS: ATD bundle implementation increased knowledge and comfort levels with managing ATD. Further studies must assess whether ATD bundles and other standardised approaches to airway emergencies reduce adverse events. Relevance to Clinical Practice A streamlined intervention bundle employed at the unit level can significantly improve knowledge and comfort in managing ATD, which may reduce morbidity and mortality in critically ill patients with tracheostomy.

Amplifying patient voices amid pandemic: Perspectives on tracheostomy care, communication, and connection.

OBJECTIVE: To investigate perspectives of patients, family members, caregivers (PFC), and healthcare professionals (HCP) on tracheostomy care during the COVID-19 pandemic. METHODS: The cross-sectional survey investigating barriers and facilitators to tracheostomy care was collaboratively developed by patients, family members, nurses, speech-language pathologists, respiratory care practitioners, physicians, and surgeons. The survey was distributed to the Global Tracheostomy Collaborative's learning community, and responses were analyzed. RESULTS: Survey respondents (n = 191) from 17 countries included individuals with a tracheostomy (85 [45 %]), families/caregivers (43 [22 %]), and diverse HCP (63 [33.0 %]). Overall, 94 % of respondents reported concern that patients with tracheostomy were at increased risk of critical illness from SARS-CoV-2 infection and COVID-19; 93 % reported fear or anxiety. With respect to prioritization of care, 38 % of PFC versus 16 % of HCP reported concern that patients with tracheostomies might not be valued or prioritized (p = 0.002). Respondents also differed in fear of contracting COVID-19 (69 % PFC vs. 49 % HCP group, p = 0.009); concern for hospitalization (55.5 % PFC vs. 27 % HCP, p < 0.001); access to medical personnel (34 % PFC vs. 14 % HCP, p = 0.005); and concern about canceled appointments (62 % PFC vs. 41 % HCP, p = 0.01). Respondents from both groups reported severe stress and fatigue, sleep deprivation, lack of breaks, and lack of support (70 % PFC vs. 65 % HCP, p = 0.54). Virtual telecare seldom met perceived needs. CONCLUSION: PFC with a tracheostomy perceived most risks more acutely than HCP in this global sample. Broad stakeholder engagement is necessary to achieve creative, patient-driven solutions to maintain connection, communication, and access for patients with a tracheostomy.

Tracheostomy for COVID-19: evolving best practice.

This article is one of ten reviews selected from the Annual Update in Intensive Care and Emergency Medicine 2021. Other selected articles can be found online at https://www.biomedcentral.com/collections/annualupdate2021 . Further information about the Annual Update in Intensive Care and Emergency Medicine is available from https://link.springer.com/bookseries/8901 .

Multidisciplinary management of laryngeal pathology identified in patients with COVID-19 following trans-laryngeal intubation and tracheostomy.

Background: COVID-19 disease often requires invasive ventilatory support. Trans-laryngeal intubation of the trachea may cause laryngeal injury, possibly compounded by coronavirus infection. Fibreoptic Endoscopic Evaluation of Swallowing (FEES) provides anatomical and functional assessment of the larynx, guiding multidisciplinary management. Our aims were to observe the nature of laryngeal abnormalities in patients with COVID-19 following prolonged trans-laryngeal intubation and tracheostomy, and to describe their impact on functional laryngeal outcomes, such as tracheostomy weaning. Methods: A retrospective observational cohort analysis was undertaken between March and December 2020, at a UK tertiary hospital. The Speech and Language Therapy team assessed patients recovering from COVID-19 with voice/swallowing problems identified following trans-laryngeal intubation or tracheostomy using FEES. Laryngeal pathology, treatments, and outcomes relating to tracheostomy and oral feeding were noted. Results: Twenty-five FEES performed on 16 patients identified a median of 3 (IQR 2-4) laryngeal abnormalities, with 63% considered clinically significant. Most common pathologies were: oedema (n = 12, 75%); abnormal movement (n = 12, 75%); atypical lesions (n = 11, 69%); and erythema (n = 6, 38%). FEES influenced management: identifying silent aspiration (88% of patients who aspirated (n = 8)), airway patency issues impacting tracheostomy weaning (n = 8, 50%), targeted dysphagia therapy (n = 7, 44%); ENT referral (n = 6, 38%) and reflux management (n = 5, 31%). Conclusions: FEES is beneficial in identifying occult pathologies and guiding management for laryngeal recovery. In our cohort, the incidence of laryngeal pathology was higher than a non-COVID-19 cohort with similar characteristics. We recommend multidisciplinary investigation and management of patients recovering from COVID-19 who required prolonged trans-laryngeal intubation and/or tracheostomy to optimise laryngeal recovery.

Expert consensus statements for the management of COVID-19-related acute respiratory failure using a Delphi method.

BACKGROUND: Coronavirus disease 2019 (COVID-19) pandemic has caused unprecedented pressure on healthcare system globally. Lack of high-quality evidence on the respiratory management of COVID-19-related acute respiratory failure (C-ARF) has resulted in wide variation in clinical practice. METHODS: Using a Delphi process, an international panel of 39 experts developed clinical practice statements on the respiratory management of C-ARF in areas where evidence is absent or limited. Agreement was defined as achieved when > 70% experts voted for a given option on the Likert scale statement or > 80% voted for a particular option in multiple-choice questions. Stability was assessed between the two concluding rounds for each statement, using the non-parametric Chi-square (χ2) test (p < 0·05 was considered as unstable). RESULTS: Agreement was achieved for 27 (73%) management strategies which were then used to develop expert clinical practice statements. Experts agreed that COVID-19-related acute respiratory distress syndrome (ARDS) is clinically similar to other forms of ARDS. The Delphi process yielded strong suggestions for use of systemic corticosteroids for critical COVID-19; awake self-proning to improve oxygenation and high flow nasal oxygen to potentially reduce tracheal intubation; non-invasive ventilation for patients with mixed hypoxemic-hypercapnic respiratory failure; tracheal intubation for poor mentation, hemodynamic instability or severe hypoxemia; closed suction systems; lung protective ventilation; prone ventilation (for 16-24 h per day) to improve oxygenation; neuromuscular blocking agents for patient-ventilator dyssynchrony; avoiding delay in extubation for the risk of reintubation; and similar timing of tracheostomy as in non-COVID-19 patients. There was no agreement on positive end expiratory pressure titration or the choice of personal protective equipment. CONCLUSION: Using a Delphi method, an agreement among experts was reached for 27 statements from which 20 expert clinical practice statements were derived on the respiratory management of C-ARF, addressing important decisions for patient management in areas where evidence is either absent or limited. TRIAL REGISTRATION: The study was registered with Clinical trials.gov Identifier: NCT04534569.

Multidisciplinary Safety Recommendations After Tracheostomy During COVID-19 Pandemic: State of the Art Review.

OBJECTIVE: In the chronic phase of the COVID-19 pandemic, questions have arisen regarding the care of patients with a tracheostomy and downstream management. This review addresses gaps in the literature regarding posttracheostomy care, emphasizing safety of multidisciplinary teams, coordinating complex care needs, and identifying and managing late complications of prolonged intubation and tracheostomy. DATA SOURCES: PubMed, Cochrane Library, Scopus, Google Scholar, institutional guidance documents. REVIEW METHODS: Literature through June 2020 on the care of patients with a tracheostomy was reviewed, including consensus statements, clinical practice guidelines, institutional guidance, and scientific literature on COVID-19 and SARS-CoV-2 virology and immunology. Where data were lacking, expert opinions were aggregated and adjudicated to arrive at consensus recommendations. CONCLUSIONS: Best practices in caring for patients after a tracheostomy during the COVID-19 pandemic are multifaceted, encompassing precautions during aerosol-generating procedures; minimizing exposure risks to health care workers, caregivers, and patients; ensuring safe, timely tracheostomy care; and identifying and managing laryngotracheal injury, such as vocal fold injury, posterior glottic stenosis, and subglottic stenosis that may affect speech, swallowing, and airway protection. We present recommended approaches to tracheostomy care, outlining modifications to conventional algorithms, raising vigilance for heightened risks of bleeding or other complications, and offering recommendations for personal protective equipment, equipment, care protocols, and personnel. IMPLICATIONS FOR PRACTICE: Treatment of patients with a tracheostomy in the COVID-19 pandemic requires foresight and may rival procedural considerations in tracheostomy in their complexity. By considering patient-specific factors, mitigating transmission risks, optimizing the clinical environment, and detecting late manifestations of severe COVID-19, clinicians can ensure due vigilance and quality care.

Critical Care Guidance for Tracheostomy Care During the COVID-19 Pandemic: A Global, Multidisciplinary Approach.

PURPOSE: Critical care nurses caring for patients with a tracheostomy are at high risk because of the predilection of SARS-CoV-2 for respiratory and mucosal surfaces. This review identifies patient-centered practices that ensure safety and reduce risk of infection transmission to health care workers during the coronavirus disease 2019 (COVID-19) pandemic. METHODS: Consensus statements, guidelines, institutional recommendations, and scientific literature on COVID-19 and previous outbreaks were reviewed. A global interdisciplinary team analyzed and prioritized findings via electronic communications and video conferences to develop consensus recommendations. RESULTS: Aerosol-generating procedures are commonly performed by nurses and other health care workers, most notably during suctioning, tracheostomy tube changes, and stoma care. Patient repositioning, readjusting circuits, administering nebulized medications, and patient transport also present risks. Standard personal protective equipment includes an N95/FFP3 mask with or without surgical masks, gloves, goggles, and gown when performing aerosol-generating procedures for patients with known or suspected COVID-19. Viral testing of bronchial aspirate via tracheostomy may inform care providers when determining the protective equipment required. The need for protocols to reduce risk of transmission of infection to nurses and other health care workers is evident. CONCLUSION: Critical care nurses and multidisciplinary teams often care for patients with a tracheostomy who are known or suspected to have COVID-19. Appropriate care of these patients relies on safeguarding the health care team. The practices described in this review may greatly reduce risk of infectious transmission.