Use of Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G)—(Equine) (BAT®) in Clinical Study Subjects and Patients: A 15-Year Systematic Safety Review

Botulism is a rare, sometimes fatal paralytic illness caused by botulinum neurotoxins. BAT® (Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G)—(Equine)) is an equine-derived heptavalent botulinum antitoxin indicated for the treatment of symptomatic botulism in adult and pediatric patients. This review assesses the cumulative safety profile for BAT product from 2006 to 2020, using data received from clinical studies, an expanded-access program, a post-licensure registry, spontaneous and literature reports. The adverse event (AE) incidence rate for BAT product was calculated conservatively using only BAT product exposures for individuals with a record (512) and was alternatively estimated using all BAT product exposure data, including post-licensure deployment information (1128). The most frequently reported BAT product-related AEs occurring in greater than 1% of the 512–1128 BAT product-exposed individuals were hypersensitivity, pyrexia, tachycardia, bradycardia, anaphylaxis, and blood pressure increase reported in 2.3–5.1%, 1.8–3.9%, 1.0–2.2%, 0.89–2.0%, 0.62–1.4%, and 0.62–1.4%, respectively. For patients properly managed in an intensive care setting, the advantages of BAT product appear to outweigh potential risks in patients due to morbidity and mortality of botulism. AEs of special interest, including bradycardia, hemodynamic instability, hypersensitivity, serum sickness, and febrile reactions in the registry, were specifically solicited.

Life-threatening complications of streptococcal sepsis: a PICU contemporary series

Background Life-threatening streptococcal sepsis nowadays represents an uncommon event in previously healthy infants and children. Critically ill patients suffering from severe streptococcal sepsis complications may present with pre-antibiotic era clinical pictures and require a timely clinical approach to achieve restitutio ad integrum. Results We report a series of four patient groups affected by an uncommon life-threatening streptococcal sepsis, each of them exhibiting some distinct features. Streptococcus Agalactiae sepsis was associated with cerebral thrombotic/ischaemic lesions, whereas severe cardiogenic shock was prominent in the Streptococcus Viridans group; Streptococcus Faecalis and β-hemolytic group A Streptococcus patients mostly reported lung complications. Conclusions Previous antibiotic treatments should not delay aggressive treatment in the intensive care setting. Early diagnostic suspicion, as well as appropriate and aggressive treatment provided within an intensive care setting are crucial for the clinical outcome.

Misfits: An ethnographic study of extremely fat patients in intensive care

<p>Critically ill fat patients pose considerable healthcare delivery and resource utilisation challenges which are often exacerbated by the patients’ critical condition and types of interventional therapies used in the intensive care environment. Added to these difficulties of managing care is the social stigma that is attached to being fat. Intensive care staff not only have to attend to the specific needs of the critically ill body but also navigate, both personally and professionally, the social terrain of stigma when providing care to this patient population. The purpose of this research was to explore the culture and influences within the intensive care setting in which doctors and nurses cared for fat patients. A focused ethnographic approach was adopted to elicit the specific knowledge and ‘situated’ experiences of caring for critically ill fat patients from the perspectives of intensive care staff. The setting for this study was an 18 bedded tertiary intensive care unit (ICU) in New Zealand. Participant observation of care practices and interviews with intensive care staff were undertaken over a four month period. This study adopted an insider perspective throughout the research process as the study site was also my place of work. The dual tensions of the nurse and researcher position are reflexively explored through the thesis. Key findings from this research reveal how fat patients were considered to be ‘misfits’ in the ICU as a result of not fitting the physical, medical, and social norms of intensive care practices. Staff managed their private perceptions of fatness during care situations through the use of emotional labour, behavioural regions, and face-work. Through the construction and presentation of the professional and private ‘face’, staff were able to establish positive social experiences for fat patients. This study has brought new understandings of fatness; often percieved as the last socially accepted form of discrimination. Conceptualising fat patients as ‘misfits’ in the intensive care setting, reveals the performances of staff in managing the social awkwardness of fat stigma. The implications of this for healthcare is the provision of clinical services that are fit for purpose and a reconceptualisation of how staff use emotional labour in order to deliver non-discriminatory care to socially stigmatised fat patients.</p>

Misfits: An ethnographic study of extremely fat patients in intensive care

<p>Critically ill fat patients pose considerable healthcare delivery and resource utilisation challenges which are often exacerbated by the patients’ critical condition and types of interventional therapies used in the intensive care environment. Added to these difficulties of managing care is the social stigma that is attached to being fat. Intensive care staff not only have to attend to the specific needs of the critically ill body but also navigate, both personally and professionally, the social terrain of stigma when providing care to this patient population. The purpose of this research was to explore the culture and influences within the intensive care setting in which doctors and nurses cared for fat patients. A focused ethnographic approach was adopted to elicit the specific knowledge and ‘situated’ experiences of caring for critically ill fat patients from the perspectives of intensive care staff. The setting for this study was an 18 bedded tertiary intensive care unit (ICU) in New Zealand. Participant observation of care practices and interviews with intensive care staff were undertaken over a four month period. This study adopted an insider perspective throughout the research process as the study site was also my place of work. The dual tensions of the nurse and researcher position are reflexively explored through the thesis. Key findings from this research reveal how fat patients were considered to be ‘misfits’ in the ICU as a result of not fitting the physical, medical, and social norms of intensive care practices. Staff managed their private perceptions of fatness during care situations through the use of emotional labour, behavioural regions, and face-work. Through the construction and presentation of the professional and private ‘face’, staff were able to establish positive social experiences for fat patients. This study has brought new understandings of fatness; often percieved as the last socially accepted form of discrimination. Conceptualising fat patients as ‘misfits’ in the intensive care setting, reveals the performances of staff in managing the social awkwardness of fat stigma. The implications of this for healthcare is the provision of clinical services that are fit for purpose and a reconceptualisation of how staff use emotional labour in order to deliver non-discriminatory care to socially stigmatised fat patients.</p>

Practice Guidelines for the Diagnosis of COVID-19-Associated Pulmonary Aspergillosis in an Intensive Care Setting

Coronavirus disease-2019 (COVID-19)-associated pulmonary aspergillosis (CAPA) is a new disease characterized by secondary Aspergillus mold infection in patients with COVID-19. It primarily affects patients with COVID-19 in critical state with acute respiratory distress syndrome, requiring intensive care and mechanical ventilation. CAPA has a higher mortality rate than COVID-19, posing a serious threat to affected individuals. COVID-19 is a potential risk factor for CAPA and has already claimed a massive death toll worldwide since its outbreak in December 2019. Its second wave is currently progressing towards a peak, while the third wave of this devastating pandemic is expected to follow. Therefore, an early and accurate diagnosis of CAPA is of utmost importance for effective clinical management of this highly fatal disease. However, there are no uniform criteria for diagnosing CAPA in an intensive care setting. Therefore, based on a review of existing information and our own experience, we have proposed new criteria in the form of practice guidelines for diagnosing CAPA, focusing on the points relevant for intensivists and pulmonary and critical care physicians. The main highlights of these guidelines include the role of CAPA-appropriate test specimens, clinical risk factors, computed tomography of the thorax, and non-culture-based indirect and direct mycological evidence for diagnosing CAPA in the intensive care unit. These guidelines classify the diagnosis of CAPA into suspected, possible, and probable categories to facilitate clinical decision-making. We hope that these practice guidelines will adequately address the diagnostic challenges of CAPA, providing an easy-to-use and practical algorithm to clinicians for rapid diagnosis and clinical management of the disease.

Improving the effectiveness of the referral process in a tertiary NICU using lean methodology concepts

Aim: To reduce the administrative time trainees spent when completing a patient referral to specialist teams in a tertiary Neonatal Intensive care setting. Methods: We designed a pre intervention and post intervention questionnaire completed prospectively by trainees describing the tasks they needed to undertake to complete a referral, the time perceived as ‘wasted’ and suggest potential solutions over a 2 month period between 1st June 2020 and 1st August 2020. We used Lean methodology to identify waste as steps that did not add value to quality patient care. We designed a NICU referral directory containing the standard operating steps, the appropriate proformas and contact details of receiving unit, a process algorithm and a collective consultant email address. Results: Our project achieved a reduction in the median time to complete a referral from 27.5 minutes to 6 minutes (p = 0.0087). The time perceived ‘wasted’ by trainees was reduced from 20 minutes to 0 minutes (p=0.006). Conclusion: Our project is a simple intervention and supports using Lean methodologies to identify waste and bring about quick improvements without significant capital investments. We demonstrate how front line staff can be engaged in identifying inefficiencies, suggest solutions which help in the successful adoption and sustainability of quality improvements.

Nurses’ Views on the Use of Physical Restraints in Intensive Care: A Qualitative Study

Despite the worldwide promotion of a “restraint-free” model of care due to the questionable ethical and legal issues and the many adverse physical and psychosocial effects of physical restraints, their use remains relatively high, especially in the intensive care setting. Therefore, the aim of the present study was to explore the experiences of nurses using physical restraints in the intensive care setting. Semi-structured interviews with 20 nurses working in intensive care units for at least three years, were conducted, recorded, and transcribed verbatim. Then, the transcripts were analyzed according to the qualitative descriptive approach by Sandelowsky and Barroso (2002). Six main themes emerged: (1) definition of restraint, (2) who decides to restrain? (3) reasons behind the restraint use, (4) physical restraint used as the last option (5) family involvement, (6) nurses’ feelings about restraint. Physical restraint evokes different thoughts and feelings. Nurses, which are the professionals most present at the patient’s bedside, have been shown to be the main decision-makers regarding the application of physical restraints. Nurses need to balance the ethical principle of beneficence through this practice, ensuring the safety of the patient, and the principle of autonomy of the person.