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1.
Critical Care Conference: 42nd International Symposium on Intensive Care and Emergency Medicine Brussels Belgium ; 27(Supplement 1), 2023.
Artículo en Inglés | EMBASE | ID: covidwho-2317174

RESUMEN

Introduction: Manipulations with continuous syringe infusions in the ICU are time-consuming and cost-intensive. Nurses often have to exchange syringes at preplanned times, but pre-emptive swapping of syringes may result in considerable unused residual volume, and thus additional waste. During vasopressor infusion, automated infusion relay is usually considered for ensuring a smooth switching between syringe pumps. However, infusion relay also allows the optimal use of drug solutions and could present an opportunity to reduce environmental footprint and lower costs. Consequently, we studied the magnitude of unused drug disposal in our ICU in a context of manual syringe exchange, to evaluate the potential benefit of an automated infusion relay function. Method(s): We performed a prospective study over 3 weeks in a 32-bed tertiary university adult ICU. All patients, except strictly isolated patients (e.g. with COVID-19, MRSA or ESBL) were included. All 50 ml syringes that were disposed of before or after use were separately collected per patient and the constituent solution and the remaining volume were recorded. Medication costs, as used internally in our hospital, were identified for the 20 most commonly used drugs or solutions. Result(s): A total of 2667 syringes from 105 subsequent adult ICU patients were collected and analyzed (Fig. 1). Expired medication or discontinuation of medication accounted for disposal of 179 (7%) completely filled syringes. The 2488 remaining syringes had a mean +/- SD residual volume of 12 +/- 13 ml (24%). This remaining medication volume had an associated cost of 5736 or 28% of total cost of fully filled syringes, or at least 100,000 on an annual basis. Conclusion(s): In our ICU approximately a quarter of syringe solutions are discarded during syringe switching. In terms of waste production, associated nursing time and associated material costs, more efficient syringe exchanges with automated infusion relay may address these three concerns.

2.
Medicina Clinica Practica ; 6(3) (no pagination), 2023.
Artículo en Inglés, Español | EMBASE | ID: covidwho-2302517

RESUMEN

Objective: Identify lung sequelae of COVID-19 through radiological and pulmonary function assessment. Design(s): Prospective, longitudinal, cohort study from March 2020 to March 2021. Setting(s): Intensive Care Units (ICU) in a tertiary hospital in Portugal. Patient(s): 254 patients with COVID-19 admitted to ICU due to respiratory illness. Intervention(s): A chest computed tomography (CT) scan and pulmonary function tests (PFT) were performed at 3 to 6 months. Main variables of interest: CT-scan;PFT;decreased diffusion capacity of carbon monoxide (DLCO). Result(s): All CT scans revealed improvement in the follow-up, with 72% of patients still showing abnormalities, 58% with ground glass opacities and 62% with evidence of fibrosis. PFT had abnormalities in 94 patients (46%): thirteen patients (7%) had an obstructive pattern, 35 (18%) had a restrictive pattern, and 58 (30%) had decreased DLCO. There was a statistically significant association between abnormalities in the follow-up CT scan and older age, more extended hospital and ICU stay, higher SAPS II and APACHE scores and invasive ventilation. Mechanical ventilation, especially with no lung protective parameters, was associated with abnormalities in PFT. Multivariate regression showed more abnormalities in lung function with more extended ICU hospitalization, chronic obstructive pulmonary disease (COPD), chronic kidney disease, invasive mechanical ventilation, and ventilation with higher plateau pressure, and more abnormalities in CT-scan with older age, more extended ICU stay, organ solid transplants and ventilation with higher positive end-expiratory pressure (PEEP). Conclusion(s): Most patients with severe COVID-19 still exhibit abnormalities in CT scans or lung function tests three to six months after discharge.Copyright © 2023

3.
European Urology ; 83(Supplement 1):S1630, 2023.
Artículo en Inglés | EMBASE | ID: covidwho-2298111

RESUMEN

Introduction & Objectives: Holmium laser enucleation of the prostate (HoLEP) has the strongest evidence base for bladder outlet surgery, despite its steep learning curve. Rapid enucleation rates can be achieved in established hands with day-case surgery being the norm in service delivery. We have previously shown the validity of such a model. With the post Covid surgical backlog we have developed a tool to support theatre utilization based on established surgeon specific operating room (OR) times for a given prostate volume in our unit based on almost 1100 cases. Material(s) and Method(s): Four HoLEP naive surgeons completed 1096 HoLEPs over 7.5 years using a 50 Watt (W) Holmium laser (Auriga XL, Boston Scientific Inc., Piranha morcellator, Richard Wolf). Pre and post-operative data including TRUS/MRI volume, flow rate, residual volume, international prostate symptom score, quality of life, stop-clock enucleation, morcellation and total operating room (OR) times, hospital stay, histology, haemoglobin, creatinine, sodium and catheter times were prospectively recorded. Mentorship was provided by a senior 100W HoLEP surgeon from an adjoining hospital. Result(s): The data was independently analysed by a bio-statistician (IN). Statistical regression analysis of unit and surgeon specific OR times vs prostate volume were used to produce predictive linear graphs of OR times (mins) for a given prostate volume for individual surgeons and the unit. [Figure presented] Conclusion(s): Use of surgeon-specific and unit specific OR times allows the opportunity to maximize theatre operating schedules to help tackle the post Covid surgical backlog. We encourage this process for index specialist procedures across units.Copyright © 2023 European Association of Urology. Published by Elsevier B.V. All rights reserved.

4.
European Respiratory Journal Conference: European Respiratory Society International Congress, ERS ; 60(Supplement 66), 2022.
Artículo en Inglés | EMBASE | ID: covidwho-2283977

RESUMEN

The airborne transmission of SARS-CoV-2 has been quickly suggested based on the stability of SARS-CoV-2 in aerosol for 3 hours. Nebulization, by a possible microorganisms contamination and/or by the aerosolization of contaminated particles, may expose health care workers. Thus, various guidelines on nebulization emerged during the SARS-CoV-2 pandemic to ensure a maximal protection. This study aimed to address the risk of airborne transmission in patients hospitalized with severe COVID-19. Ten severe COVID-19 patients were recruited at the admission in the hospital. They were treated by nebulization with a standard single-use jet nebulizer operating at 8 L/min with a T piece connected to a mouthpiece and a filter. Immediately after the first nebulization, the residual solution of each nebulizer was sampled. Then, the nebulizers were refilled with isotonic saline solution to complete the residual volume. The filter was replaced by a BioSampler (SKC 20-mL) loaded with 20 mL phosphatebuffered saline and 0.5% bovine serum albumin. The nebulizer was driven by a compressed air supply, and a 10minnebulization was performed again on the bench. The emitted aerosol was continuously collected during the nebulization. The nominal and emitted dose were sampled. The SARS-CoV-2 viral load was quantified in all samples by RT-PCR. No SARS-CoV-2 RNA was found in any sample for all nebulizations. The result of this study shows no SARS-CoV-2 nebulizers contamination by COVID-19 patients at hospital and does not support the role of nebulizers in terms of aerosol virus dissemination in air. Nevertheless, exhaled virus by the patient itself remains and must be considered independently to the nebulizer.

5.
Journal of the Intensive Care Society ; 23(1):111-112, 2022.
Artículo en Inglés | EMBASE | ID: covidwho-2043005

RESUMEN

Introduction: Prone positioning and veno-venous extracorporeal membrane oxygenation (VV-ECMO) can improve oxygenation in patients with COVID 19-induced acute respiratory distress syndrome (ARDS).1 Enteral feeding in the prone position has challenges, including possible aspiration risk of gastric contents and potential for disruption to enteral feeding.2 National guidelines2 were implemented locally;including a reduction in the maximum acceptable gastric residual volume (GRV) and the avoidance of bolus feeding while patients were in prone position. Objectives: • To explore the nutritional adequacy of patients in the prone position with COVID-19 on our critical care unit during the second surge (November 2020-April 2021) • To compare nutritional adequacy of days when patients were in prone versus supine position • To identify any factors that impacted on nutritional adequacy • To provide recommendations for improvement Methods: Patients with COVID-19 who required intubation, were placed in prone position at any time during their admission and had been assessed by the dietitian, were included. Total daily energy and protein intakes, from enteral (EN) and parenteral nutrition (PN), propofol and intravenous glucose were obtained from our computerised information system (Metavision) for each full day. If nutritional aims were not met then reasons for this were investigated. Nutritional adequacy was defined as ≥ 80% of energy and protein received per day.3 Results: Data for 34 patients was collected (see Table 1). A total of 1142 ICU days were included: 106 (9.3%) prone position days and 1036 (90.7%) supine position days. Patients received EN on 1098 days (96.1%) and PN on 44 days (3.9%). Only 4 of the 44 PN days occurred whilst a patient was in the prone position (0.4%). On prone position days, patients received an average 80% of their prescribed energy and 56% of their prescribed protein requirements, compared with 95% prescribed energy and 84% prescribed protein on supine position days. The average received across both prone and supine position days was 94% energy and 82% of protein. The 4 most frequent barriers to meeting protein requirements when in prone position were: • Reduction of NG feed rate when GRV's were higher than maximum acceptable volume • Use of a standard 4g protein/100ml 'Out of Hours' enteral feed • Fasting for procedures • Failure to give protein supplement boluses when patient returned to supine position Conclusion: Patient position affected nutritional intake, with energy and protein intake being lower on prone position days compared with supine position days. As only 9.3% of total ICU days were prone position days, average energy and protein received across all days still achieved nutritional adequacy. An increase in a patient's prone position days during ICU admission is likely to result in greater nutritional deficit, particularly for protein. Recommendations to improve nutritional adequacy on prone position days: • Consider use of post-pyloric feeding to increase feed tolerance • Use of a higher protein 'out of hours' enteral feed • Raised awareness of standard fasting times to ensure minimum disruption to feeding • Consider administration of protein supplement boluses in prone position when GRV's are within the accepted range .

6.
Clinical Nutrition ESPEN ; 48:511, 2022.
Artículo en Inglés | EMBASE | ID: covidwho-2003966

RESUMEN

The aim of this analysis was to compare route and adequacy of nutrition support in patients with COVID19 admitted to an intensive care unit (ICU) between March-June 2020 (T1) compared to January-April 2021 (T2). Parameters related to nutrition support were collected from the records of all patients admitted to ICU with COVID19 with length of stay of ≥7days on mechanical ventilation requiring artificial nutrition support. Data was collected during the late acute phase which was defined as day 4-7 post intubation. Energy and protein intake was compared to calculated estimated nutritional requirements. 35 patients met the inclusion criteria in T1, 94% were on enteral nutrition (EN), 3% parenteral nutrition (PN) and 3% EN+PN. In T2, there were 54 patients (92% EN, 2% PN and 6% EN+PN). [Formula presented] Of patients who achieved <70% of energy and protein requirements in T1 (n=17) 35% had constipation or ileus and 47% had GI intolerance (high gastric residual volumes or vomiting). In T2 (n=19), 84% experienced constipation or ileus and 63% had GI intolerance. 35% of patients in T1 had hypernatraemia vs. 47% in T2 and 41% in T1 had hyperglycaemia vs. 100% in T2 despite only 12% and 32% of patients respectively having a history of diabetes. Despite a higher incidence of GI intolerance in T2, a statistically significant improvement in achieving energy targets was noted. Learning from T1 showed that where strategies to improve GI tolerance are unsuccessful supplementary PN should be considered without delay to optimise nutritional intake. There was a clinically significant trend in protein intake which may be attributed to prompt initiation of modular protein supplements or perhaps an earlier transition from fat-based sedation. Meeting protein requirements while preventing overfeeding remains a challenge in the ICU. Disclosure of Interest: None Declared

7.
Clinical Nutrition ESPEN ; 48:499, 2022.
Artículo en Inglés | EMBASE | ID: covidwho-2003954

RESUMEN

Early enteral feeding is important in maintaining the integrity of the gastrointestinal tract mucosal barrier and associated with less bacterial translocation and decreased stimulation of the systemic inflammatory response and subsequent improved outcomes in intensive care (ICU) patients. Enteral feeding by nasogastric (NG) tubes is the preferred route of nutritional support for most ICU patients. However, ICU patients with delayed gastric emptying and poor intestinal motility may not tolerate gastric feeding and may therefore benefit from post-pyloric feeding via nasojejunal (NJ) tubes1. We reviewed the effectiveness of 35 NJ tube placement in 24 patients on ICU between January and March 2021. The M:F ratio was 4:1, median age 69 years (30–80 years) and 54% of patients were non-White British. 10 patients (42%) had diabetes and 54% had COVID-19 as part of their admitting diagnoses. The median BMI was 25 (range 20 – 32.3) and none of the patients were identified as high risk for refeeding syndrome at the time of NJ tube insertion. Nutritional information was unavailable on 5 patients. Of the remaining 19 patients, 26% of patients (n=5) were commenced on parenteral nutrition (PN) within 48 hours of NJ insertion. Only 1 patient was able to meet their nutritional requirements enterally via NJ tube at 5 days;a further 2 patients had their nutritional requirements met with supplemental PN. In 8 of 22 referrals the indication for NJ tube insertion was because an NG tube could not be passed. The evaluation revealed discrepancies in adherence to protocols for high gastric residual volumes and prokinetic use. Documentation surrounding decision making, requesting and inserting an NJ tube was poor and probably reflects the complexity of the patients, involvement of multiple clinical teams, and various documentation modalities (i.e., verbal, written and different electronic systems). There was clinical dispute regarding the indication for NJ tube insertion in 23% of cases (documented in 3 of 13 referrals for NJ tube insertion). Where documentation was available 43% of patients (n=10) had an NJ tube placed on the day of request;the median time from request to insertion was 1 day (range 0-10). 5 patients had more than one NJ tube inserted (median 3;range 2–5). There was variation in experience and expertise of the endoscopists placing the NJ tubes. NJ tube feeding is considered to be less expensive and have less complications than PN2. However, our evaluation has revealed a range of issues relating to both the insertion and use of NJ tubes in an ICU setting. The true resource ‘cost’ of NJ tube insertion is probably underestimated in the literature and the complications of PN probably overestimated in the context of modern ICU and nutrition support team clinical practices. We suspect that our clinical experience is not unique and that more research is needed in this area. We are using this work to educate clinical teams, standardise documentation, provide better support and supervision for endoscopists, and raise awareness of the benefit and need for supplemental PN where nutritional requirements are not consistently reached enterally. 1 Schröder S, Hülst S V, Claussen M et al. Postpyloric feeding tubes for surgical intensive care patients. Anaesthetist 2011;60 (3): 214-20. 2 Lochs H, Dejong C, Hammarqvist F et al. ESPEN Guidelines on enteral nutrition: Gastroenterology. Clin Nutr 2006;25(20: 260-74.

8.
Clinical Nutrition ESPEN ; 48:495, 2022.
Artículo en Inglés | EMBASE | ID: covidwho-2003949

RESUMEN

The COVID-19 pandemic led to a surge in patients being admitted to the Intensive Care Unit (ICU) and increased dietetic input was required for their daily nutritional management. Non-ICU dietitians were upskilled to meet this increased demand – resulting in an increase to 5 band 6 dietitians and 1 band 7 dietitian overseen by the band 8a clinical lead. The service also changed from a 5-day to a 7-day service. The aim of this service evaluation was to analyse changes in nutritional outcomes during the COVID-19 pandemic, and how changes to the dietetic service impacted upon dietetic outcomes. Outcomes included energy and protein provision, feed type used and prokinetic use. Data was collected for all ICU patients under dietetic care with a confirmed COVID-19 diagnosis for the period of 22/03/2020 to 04/06/2020 (75 days). Total patient cohort equalled 66. Patients were reviewed daily until the patient was discharged from ICU or the patient passed away. All data was then retrospectively analysed using descriptive statistics, and an independent t-test was used to compare COVID-19 feed delivery to previous feed deliverydata. Ethical approval was not required for this service evaluation. Of the 66 patients, 62 required enteral nutrition (EN). Feeding was commenced within 48 hours of ICU admission in 92% of patients. Average percentage feed delivery was 82.4% for energy and protein. This total does not include additional protein supplementation;therefore, the overall protein delivery was higher, with 36% of patients being prescribed 1 to 2 20g protein supplements per day. A total of 60% of patients were initially started on a fluid restricted feed for fluid balance or due to being proned. A total of 50% of patients continued with a fluid restricted feed, with 44% of patients receiving a standard protocol feed (1kcal/ml high-protein feed) and 6% receiving a peptide or renal feed. Prokinetics were required in 35% of patients. A total of 3% of patients (n=2) required parenteral nutrition due to persistent high gastric residual volumes despite prokinetics. Of the 66 patients, 46 (70%) were discharged alive from ICU. Of these, 70% were receiving total or supplementary EN at the time of discharge from the ICU. A number of barriers to maintaining high standards of patient outcomes arose at the onset of the COVID-19 pandemic. These included disruptions to normal MDT working, challenges in undertaking face-to-face assessments and reviews, and an increased caseload and footfall - thereby increasing the demand for ICU trained dietitians. Despite these barriers, this service evaluation demonstrates that percentage feed delivery remained relatively stable when compared to the pre-COVID 2020 audit (n = 35) - 82.4% vs. 85% respectively. An independent-samples t-test was conducted to compare feed delivery in pre-COVID and COVID-19 samples. There was no significant difference in the scores for pre-COVID (M = 85%, SD = 13.4) and COVID (M = 82.4%, SD = 16.8) samples;t(180) = -0.81, p =.42. This is despite 36% of patients requiring proning during COVID vs. 0% pre-COVID, and increased gastrointestinal intolerance evidenced by 35% of patients requiring prokinetics vs. 29% pre-COVID. These factors eliminated the ability to utilise ‘catch-up’ feeding, which significantly improves feed delivery in normal circumstances. This suggests that changes in dietetic provision of service, including delivering a 7-day service, thereby allowing more prompt management of nutritional issues and improved access to dietetic expertise, facilitated the maintenance of the pre-existing high standards of nutritional care. Achieving this degree of feed delivery necessitated the use of a variety of different feeds – to manage tolerance, fluid volume, electrolyte imbalances and ensure nutritional adequacy. Adapting feeding regimens to best meet the patients need is a key role of the dietitian, and in the absence of dietetic input it is unlikely these feeding strategies would have been utilised. The COVID-19 pandemic presented new challenges and obstacles to eve y aspect of the healthcare sector;necessitating fast adaptations, novel methods of working and reinforcing the importance of multidisciplinary teams to guide patient care in the absence of evidence-based guidelines. This service evaluation demonstrates that forward-planning and the expansion of services in alignment with demand can assure that patient care need not be compromised, despite the unprecedented challenges and barriers presented by the COVID-19 pandemic.

9.
Clinical Nutrition ESPEN ; 48:487, 2022.
Artículo en Inglés | EMBASE | ID: covidwho-2003945

RESUMEN

Up to 10% of COVID-19 patients require respiratory and hemodynamic support in the ICU and are at an increased risk of malnutrition (1). Where enteral nutrition is impossible, contraindicated, or insufficient then parenteral nutrition (PN) is warranted, and considered safe in the critically ill cohort (2, 3). We report the characteristics and outcomes for ventilated patients with COVID-19 who received PN on ICU. A retrospective observational study was undertaken of COVID-19 ICU patients between March-April 2020 (“wave1”) and December-March 2021 (“wave2”). Nutritional risk was calculated using The NUTRIC score (4). Data was analysed in Microsoft Excel. In total, 17 patients with COVID-19 (7 in “wave1”, 10 in “wave2”) received PN for an average of 8.6 ± 4 (range 4-16) days during their admission. 1. Patient characteristics (n=17) [Formula presented] Indications for PN were high gastric residual volumes (GRVs) (70%), haemodynamic instability and impaired feed delivery. In wave 2, bedside Naso-jejunal tube (NJT) placement was available. Six patients had successful NJT insertion, all of which subsequently achieved nutritional targets enterally, and PN was discontinued. 35% of patients had a NUTRIC score ≥5 and required longer on PN (mean 10.5 days) versus those with a NUTRIC score <4 (mean 7.1 days). Biochemical refeeding was seen in 50% of patients. In conclusion, ventilated COVID-19 patients on the ICU who required PN had complex nutritional needs, and significant levels of refeeding. Accrued nutritional deficit due to high GRV’s was our primary indication for PN commencement. They had a high mortality rate, when compared to national ICNARC mortality data (5), suggesting PN was provided at the point of worsening multi-organ failure. 1. Thibault R, Seguin P, Tamion F, et al. Nutrition of the COVID-19 patient in the intensive care unit (ICU): a practical guidance. Crit Care 2020;24: 447. 2. Harvey S E, Parrott F, Harrison D A, et al. Trial of the route of early nutrition support in critically ill adults. N Engl J Med 2014;371: 1673-1684. 3. Singer P, Blaser A, Berger M, et al. ESPEN guideline on clinical nutrition in the intensive care unit. Clin Nutr 2019;38: 48-79. 4. Heyland D K, Dhaliwal R, Jiang X, et al. Identifying critically ill patients who benefit the most from nutrition therapy: the development and initial validation of a novel risk assessment tool. Crit Care 2011;15: R268. 5. ICNARC report on COVID-19 in critical care: England, Wales and Northern Ireland 3 June 2021 (Accessed June 14, 2021, at )

10.
Cardiopulmonary Physical Therapy Journal ; 33(1):e29-e30, 2022.
Artículo en Inglés | EMBASE | ID: covidwho-1677325

RESUMEN

PURPOSE/HYPOTHESIS: An increasing number of patients with COVID-19 are being referred to outpatient cardiopulmonary rehabilitation programs with a growing, but still limited understanding of the key limitations in this patient population. The purpose of this study was to examine the relationship between baseline inspiratory muscle performance (IMP) and several functional performance measures (FPM) as well as depression (D) and quality of life (QOL) hypothesizing that IMP would be significantly correlated to FPM, D, and QOL. NUMBER OF SUBJECTS: 12 patients (6 men and 6 women with a mean ± SD age and BMI of 48 ± 14 years and 33 ± ± kg/m2) diagnosed with COVID-19. MATERIALS AND METHODS: IMP was examined via the PrO2 from residual volume providing the maximal inspiratory pressure (MIP) at 1-2 seconds of inspiration and the sustained maximal inspiratory pressure (SMIP) from MIP to total lung capacity. The 6-minute walk test (6MWT), timed-upand-go (TUG), and 5x-sit-to-stand (5xSS) were performed using standardized methods while D and QOL were measured with the Patient Health Questionaire-9 (PHQ9) and Ferrans & Powers QOL instruments, respectively. Descriptive statistics and non-parametric analyses were performed with statistical significance set at P <.05. RESULTS: The mean ± SD MIP and SMIP were 76 ± 23 cm H2O and 305 ± 160 PTU (75 ± 17% and 49 ± 14% of predicted, respectively) with both MIP and SMIP significantly lower than predicted values of 99 ± 16 cm H2O and 604 ± 233 PTU, respectively. The mean ± SD of 6MWT, TUG, and 5xSS were 343 ± 144 m, 7.4 ± 2.2 s, and 12.0 ± 3.3 s, respectively. The mean ± SD PHQ9 and QOL were 7.9 ± 6.1 and 21.3 ± 4.8, respectively. Only SMIP and height were significantly different between men and women (431 ± 116 vs 180 ± 70 PTU and 182 ± 9 vs 161 ± 7 cm, respectively). IMP was not significantly correlated to FPM, but a near significant relationship was found between MIP and TUG (r = -.65;P = .06) and a trend was found between SMIP and PHQ9 (r = -.49;P =.10). Significant correlations were found between several FPM including 5xSS and 6MWT as well as TUG (r = -.64 and .81, respectively;P <.05) and the PHQ9 and FPQOL (r = -.73;P = .02). CONCLUSIONS: IMP is significantly impaired in patients with COVID-19 and the percent of predicted value of SMIP lower than MIP (49% vs 75%). Although IMP was not significantly correlated to FPM, significant correlations among several FPM highlight the functional impairments and D associated with COVID-19 that appear to impair QOL. CLINICAL RELEVANCE: IMP is significantly impaired in patients with COVID-19 with SMIP being a possible target of inspiratory muscle training (IMT). FPM like the 5xSS, 6MWT, and TUG appear to capture the impairments associated with COVID-19, but further examination of these measures and the influence of IMP on them as well as the effect of targeted IMT on SMIP is needed.

11.
Pulm Ther ; 7(2): 503-516, 2021 Dec.
Artículo en Inglés | MEDLINE | ID: covidwho-1540322

RESUMEN

INTRODUCTION: Lung hyperinflation in chronic obstructive pulmonary disease (COPD) is associated with activity limitation, impaired cardiac output, and mortality. Several studies have demonstrated that long-acting muscarinic antagonists (LAMAs) delivered by dry powder inhalers can promote lung deflation; however, the potential of nebulized LAMAs on improving hyperinflation in COPD is currently unknown. METHODS: This single-center, randomized, double-blind, two-way crossover study (NCT04155047) evaluated the efficacy of a single dose of nebulized LAMA [glycopyrrolate (GLY) 25 µg] versus placebo in patients with COPD and lung hyperinflation. Patients with moderate-to-severe COPD and a residual volume (RV) ≥ 130% of predicted normal were included. The primary endpoint was changed from baseline in RV at 6 h post-treatment. Other endpoints included changes from baseline in spirometric and plethysmographic measures up to 6 h post-treatment. RESULTS: A total of 22 patients (mean pre-bronchodilator RV, 153.7% of predicted normal) were included. The primary objective of the study was not met; the placebo-adjusted least squares (LS) mean [95% confidence interval (CI) change from baseline in RV with GLY at 6 h post-treatment was - 0.323 l (- 0.711 to 0.066); p = 0.0987]. A post hoc evaluation of the primary analysis was conducted after excluding a single statistical outlier; substantial improvements in RV with GLY compared with placebo was observed after exclusion of this outlier [placebo-adjusted LS mean change from baseline (95% CI) in RV was - 0.446 l (- 0.741 to - 0.150)]. Improvements from baseline were also observed with GLY compared with placebo in spirometric and plethysmographic measures up to 6 h post-treatment. GLY was generally safe, and no new safety signals were detected. CONCLUSIONS: This is the first study to evaluate the effect of nebulized GLY on lung deflation. Nebulized GLY resulted in marked improvements in RV up to 6 h post-treatment, compared with placebo. Improvements were also observed with GLY in spirometric and plethysmographic parameters of lung function. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT04155047.

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