Evaluation and Management of Dyspnea in Hypermobile Ehlers-Danlos Syndrome and Generalized Hypermobility Spectrum Disorder: Protocol for a Pilot and Feasibility Randomized Controlled Trial.

BACKGROUND: Dyspnea is a prevalent symptom in individuals with hypermobile Ehlers-Danlos Syndrome (hEDS) and generalized hypermobility spectrum disorder (G-HSD), yet its contributors have not been identified. One known contributor to dyspnea is respiratory muscle weakness. The feasibility and effectiveness of inspiratory muscle training (IMT) in combination with standard-of-care rehabilitation (aerobic, resistance, neuromuscular stabilization, and balance and proprioception exercises) in improving respiratory muscle strength and patient-reported outcomes in patients with hEDS or G-HSD have not been evaluated. OBJECTIVE: This study aims to evaluate dyspnea, respiratory muscle strength, and patient-reported outcome measures (PROMs) in hEDS or G-HSD compared with healthy controls and to assess the feasibility of a randomized controlled trial of IMT and standard-of-care rehabilitation for improving respiratory muscle strength, exercise capacity, and PROMs compared with standard-of-care rehabilitation in hEDS and G-HSD. METHODS: The study will include 34 participants with hEDS or G-HSD and 17 healthy, age- and sex-matched controls to compare respiratory muscle structure and function and PROMs. After baseline assessments, participants with hEDS or G-HSD will be randomized into the intervention group and provided IMT combined with Ehlers-Danlos Syndrome standard-of-care rehabilitation or into the usual care group, and provided only standard-of-care rehabilitation for 8 weeks. The intervention group will be prescribed IMT in their home environment using the POWERbreathe K5 IMT device (POWERbreathe International Ltd). IMT will comprise 2 daily sessions of 30 breaths for 5 days per week, with IMT progressing from 20% to 60% of the baseline maximal inspiratory pressure (MIP) over an 8-week period. Feasibility will be assessed through rates of recruitment, attrition, adherence, adverse events, and participant satisfaction. The primary pilot outcome is MIP change over an 8-week period in hEDS or G-HSD. Secondary outcomes will include the evaluation of dyspnea using Medical Research Council Scale and 18-point qualitative dyspnea descriptors; diaphragmatic thickening fraction using ultrasound; respiratory muscle endurance; pulmonary function; prefrontal cortical activity using functional near-infrared spectroscopy; aerobic capacity during cardiopulmonary exercise testing; quality of life using Short Form-36; and scores from the Depression, Anxiety, and Stress scale-21. These measures will also be performed once in healthy controls to compare normative values. Multivariable regression will be used to assess the contributors to dyspnea. Paired 2-tailed t tests will be used to assess the changes in MIP and secondary measures after 8 weeks of IMT. RESULTS: Study recruitment began in August 2021 and, with several disruptions owing to COVID-19, is expected to be completed by December 2023. CONCLUSIONS: This study will provide a better understanding of the factors associated with dyspnea and the feasibility and effectiveness of IMT combined with standard-of-care rehabilitation. IMT may be a novel therapeutic strategy for improving respiratory muscle function and patient-reported outcomes in individuals with hEDS or G-HSD. TRIAL REGISTRATION: ClinicalTrials.gov NCT04972565; https://clinicaltrials.gov/ct2/show/NCT04972565. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/44832.

A hood shield reduces postdoffing contamination during simulated COVID-19 airway management: an exploratory, simulation-based randomized study.

PURPOSE: SARS-CoV-2 poses a significant occupational health threat to health care workers performing aerosol-generating medical procedures, with a threefold increased risk of a positive test and predicted infection compared with the general population. Nevertheless, the personal protective equipment (PPE) configuration that provides better protection with lower contamination rates is still unknown. METHODS: We enrolled 40 practitioners with airway management training (anesthesiologists, anesthesia assistants/nurses) in an exploratory, simulation-based randomized study. We evaluated the performance of a novel, locally designed hood (n = 20) in terms of protection from surrogate contamination using an ultraviolet (UV) marker during a standardized urgent intubation procedure and a simulated episode of coughing in a high-fidelity simulation setting compared with standard PPE (n = 20). The primary outcome was the presence of residual UV fluorescent contamination on any base clothing or exposed skin of the upper body after doffing PPE assessed by a blinded evaluator. RESULTS: The proportion of participants with residual contamination on any base clothing or exposed skin of the upper body after doffing was less than half in the hood PPE group compared with the standard PPE group (8/20 [40%] vs 18/20 [90%], respectively; P = 0.002). CONCLUSIONS: Compared with standard PPE, enhanced PPE with a locally designed prototype hood was associated with reduced contamination of the upper torso and fewer body areas being exposed to droplets after a simulated aerosol-generating scenario without designed airflow. STUDY REGISTRATION: ClinicalTrials.gov (NCT04373096); registered 4 May 2020.

RéSUMé: OBJECTIF: Le SRAS-CoV-2 représente une menace importante pour la santé au travail des travailleurs de la santé réalisant des interventions médicales générant des aérosols, avec un risque trois fois plus élevé de test positif au SRAS-CoV-2 et d'infection prédite au SRAS-CoV-2 par rapport à la population générale. Néanmoins, la configuration optimale des équipements de protection individuelle (EPI) offrant la meilleure protection avec des taux de contamination plus faibles est encore inconnue. MéTHODE: Nous avons recruté 40 praticiens ayant une formation en prise en charge des voies aériennes (anesthésiologistes, assistants en anesthésie/personnel infirmier) dans le cadre d'une étude exploratoire randomisée de simulation. Nous avons évalué la performance d'un nouveau capuchon conçu localement (n = 20) par rapport aux EPI standards (n = 20) en termes de protection contre la contamination de substitution à l'aide d'un marqueur ultraviolet (UV) au cours d'une procédure d'intubation urgente normalisée et d'un épisode simulé de toux dans un environnement de simulation haute fidélité. Le critère d'évaluation principal était la présence d'une contamination résiduelle par fluorescence UV sur les vêtements de base ou la peau exposée du haut du corps après le retrait des EPI telle qu'évaluée par un évaluateur en aveugle. RéSULTATS: La proportion de participants présentant une contamination résiduelle sur les vêtements de base ou la peau exposée du haut du corps après le retrait des équipements de protection était de moins de la moitié dans le groupe ayant porté le capuchon par rapport au groupe EPI standard (8/20 [40 %] vs 18/20 [90 %], respectivement; P = 0,002). CONCLUSION: Par rapport aux EPI standards, les EPI améliorés avec un prototype de capuchon conçu localement étaient associés à une contamination réduite du haut du torse et à moins de zones du corps exposées aux gouttelettes après une mise en situation simulée de génération d'aérosols sans flux d'air préconçu. ENREGISTREMENT DE L'éTUDE: clinicaltrials.gov (NCT04373096); enregistrée le 4 mai 2020.

Automated digital counselling with social network support as a novel intervention for patients with heart failure: protocol for randomised controlled trial.

INTRODUCTION: Heart failure (HF) symptoms improve through self-care, for which adherence remains low among patients despite the provision of education for these behaviours by clinical teams. Open Access Digital Community Promoting Self-Care, Peer Support and Health Literacy (ODYSSEE-vCHAT) combines automated digital counselling with social network support to improve mortality and morbidity, engagement with self-care materials, and health-related quality of life. METHODS AND ANALYSIS: Use of ODYSSEE-vCHAT via Internet-connected personal computer by 162 HF patients will be compared with a control condition over 22 months. The primary outcome is a composite index score of all-cause mortality, all-cause emergency department visits, and HF-related hospitalisation at trial completion. Secondary outcomes include individual components of the composite index, engagement with self-care materials, and patient-reported measures of physical and psychosocial well-being, disease management, health literacy, and substance use. Patients are recruited from tertiary care hospitals in Toronto, Canada and randomised on a 1:1 ratio to both arms of the trial. Online assessments occur at baseline (t=0), months 4, 8 and 12, and trial completion. Ordinal logistic regression analyses and generalised linear models will evaluate primary and secondary outcomes. ETHICS AND DISSEMINATION: The trial has been approved by the research ethics boards at the University Health Network (20-5960), Sunnybrook Hospital (5117), and Mount Sinai Hospital (21-022-E). Informed consent of eligible patients occurs in person or online. Findings will be shared with key stakeholders and the public. Results will allow for the preparation of a Canada-wide phase III trial to evaluate the efficacy of ODYSSEE-vCHAT in improving clinical outcomes and raising the standard of outpatient care. TRIAL REGISTRATION NUMBER: NCT04966104.

Physiological Effects of Wearing N95 Respirator on Medical Staff During Prolong Work Hours in Covid-19 Departments.

OBJECTIVE: The objective of the current study was to determine gas exchange abnormalities and physiological changes among healthcare workers during a 4-hour emergency department (ED) shift while wearing the N95 respirator. METHODS: Single-center prospective observational study. Comparisons of paired measurements were performed using a non-parametric Wilcoxon matched-pairs signed-rank test. Results: Forty-one subjects were included. Prolonged N95 respirator use was associated with a significant decline in plasma pH (7.35 mmHg vs 7.34 mmHg, P = 0.02), PvO 2 (23.2 mmHg vs 18.6 mmHg, P < 0.001) and a concurrent increase in EtCO 2 (32.5 mmHg vs 38.5 mmHg, P < 0.0001). PvCO 2 and bicarbonate levels did not differ. No significant change was observed for heart rate or oxygen saturation. CONCLUSION: Using an N95 respirator for prolonged periods by healthcare professionals may provoke changes in gas exchange. The clinical significance of these changes remains to be determined.

Feasibility of a Home-Based Exercise Program for Managing Posttransplant Metabolic Syndrome in Lung and Liver Transplant Recipients: Protocol for a Pilot Randomized Controlled Trial.

BACKGROUND: Posttransplant metabolic syndrome (PTMS) is a common contributor to morbidity and mortality among solid organ transplant recipients in the late posttransplant period (≥1 year). Patients diagnosed with PTMS are at a higher risk of cardiovascular disease and frequently experience decreased physical function and health-related quality of life (HRQL). Studies in the early posttransplant period (<1 year) have shown the benefits of facility-based exercise training on physical function and HRQL, but have not evaluated the effects on metabolic risk factors. It remains unclear whether home-based exercise programs are feasible and can be delivered at a sufficient exercise dose to have effects on PTMS. This protocol outlines the methodology of a randomized controlled trial of a partly supervised home-based exercise program in lung transplant (LTx) and orthotopic liver transplant (OLT) recipients. OBJECTIVE: This study aims to evaluate the feasibility (ie, recruitment rate, program adherence, attrition, safety, and participant satisfaction) of a 12-week individualized, home-based aerobic and resistance training program in LTx and OLT recipients initiated 12 to 18 months after transplantation, and to assess estimates of intervention efficacy on metabolic risk factors, exercise self-efficacy, and HRQL. METHODS: In total, 20 LTx and 20 OLT recipients with ≥2 cardiometabolic risk factors at 12 to 18 months after transplantation will be randomized to an intervention (home-based exercise training) or control group. The intervention group will receive an individualized exercise prescription comprising aerobic and resistance training, 3 to 5 times a week for 12 weeks. Participants will meet on a weekly basis (via videoconference) with a qualified exercise professional who will supervise exercise progression, provide support, and support exercise self-efficacy. Participants in both study groups will receive a counseling session on healthy eating with a dietitian at the beginning of the intervention. For the primary aim, feasibility will be assessed through recruitment rate, program adherence, satisfaction, attrition, and safety parameters. Secondary outcomes will be measured at baseline and 12 weeks, including assessments of metabolic risk factors (ie, insulin resistance, abdominal obesity, blood pressure, and cholesterol), HRQL, and exercise self-efficacy. Descriptive statistics will be used to summarize program feasibility and effect estimates (means and 95% CIs) for sample size calculations in future trials. RESULTS: Enrollment started in July 2021. It is estimated that the study period will be 18 months, with data collection to be completed by December 2022. CONCLUSIONS: A partly supervised home-based, individually tailored exercise program that promotes aerobic and resistance training and exercise self-efficacy may be an important intervention for improving the metabolic profile of LTx and OLT recipients with cardiometabolic risk factors. Thus, characterizing the feasibility and effect estimates of home-based exercise constitutes the first step in developing future clinical trials designed to reduce the high morbidity associated with PTMS. TRIAL REGISTRATION: ClinicalTrials.gov NCT04965142; https://clinicaltrials.gov/ct2/show/NCT04965142. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/35700.