Comparison of Three Reconstitution Devices: A Simulated Time and Use Study.

The objective of this study was to compare residual volume and time to prepare and reconstitute cefazolin using 3 different reconstitution devices while observing for use errors, participant feedback, and particulate after reconstitution. After demonstrations on the use of each device and practicing twice with each device, participants performed reconstitutions 3 times per device while being timed and observed on device preparation and assembly, mixing the drug with intravenous fluid into vials, and transfer of vial contents into the intravenous bags. Participants completed surveys to assess perceptions on use of each device. Intravenous bags were then hung for 60 minutes and observed for residual fluid and particulate matter. Residual vial volumes ranged from 0.05 mL to 2.6 mL: >0.3 mL in Device 2 (16.7%), Device 1 (55.6%), and Device 3 (81.1%). Most participants (83%) had experience with Device 1. Mean (standard deviation) total time in seconds to reconstitute medication significantly differed between devices (P<0.001): Device 1, 70.98 (15.72), Device 2, 99.11 (14.87), Device 3, 103.7 (18.99). Device assembly took the longest time and significantly differed between devices (P<0.001): Device 1, 18.76 (8.13), Device 2, 36.09 (8.05), and Device 3, 31.21 (7.75). Survey results (60=max score) were significantly different (P<0.001): Device 1, 54.5 (5.3), Device 2, 44 (13.1), Device 3, 37.1 (9.1). Nurses ranked Device 1 the highest (79%) and pharmacy technicians favored Device 2 (60%). No particulates were found (n = 270). Potentially significant residual vial volume was found and use errors were concerning in Device 2 and Device 3, potentially resulting in incomplete medication dosing. Mean times for reconstitution were <104 seconds, with Device 1 being the fastest and most favored.

A 1-minute blood test detects decreased immune function and increased clinical risk in COVID-19 patients.

Upon infection with SARS-CoV-2, the virus that causes COVID-19, most people will develop no or mild symptoms. However, a small percentage of the population will become severely ill, and some will succumb to death. The clinical severity of COVID-19 has a close connection to the dysregulation of the patient's immune functions. We previously developed a simple, nanoparticle-enabled blood test that can determine the humoral immune status in animals. In this study, we applied this new test to analyze the immune function in relation to disease severity in COVID-19 patients. From the testing of 153 COVID-19 patient samples and 142 negative controls, we detected a drastic decrease of humoral immunity in COVID-19 patients who developed moderate to severe symptoms, but not in patients with no or mild symptoms. The new test may be potentially used to monitor the immunity change and predict the clinical risk of patients with COVID-19.

Original Research: Oral Care as Prevention for Nonventilator Hospital-Acquired Pneumonia: A Four-Unit Cluster Randomized Study.

BACKGROUND: Nonventilator hospital-acquired pneumonia (NV-HAP) presents a serious and largely preventable threat to patient safety in U.S. hospitals. There is an emerging body of evidence on the effectiveness of oral care in preventing NV-HAP. PURPOSE: The primary aim of this study was to determine the effectiveness of a universal, standardized oral care protocol in preventing NV-HAP in the acute care setting. The primary outcome measure was NV-HAP incidence per 1,000 patient-days. METHODS: This 12-month study was conducted on four units at an 800-bed tertiary medical center. Patients on one medical and one surgical unit were randomly assigned to receive enhanced oral care (intervention units); patients on another medical and another surgical unit received usual oral care (control units). RESULTS: Total enrollment was 8,709. For the medical control versus intervention units, oral care frequency increased from a mean of 0.95 to 2.25 times per day, and there was a significant 85% reduction in the NV-HAP incidence rate. The odds of developing NV-HAP were 7.1 times higher on the medical control versus intervention units, a significant finding. For the surgical control versus intervention units, oral care frequency increased from a mean of 1.18 to 2.02 times per day, with a 56% reduction in the NV-HAP incidence rate. The odds of developing NV-HAP were 1.6 times higher on the surgical control versus intervention units, although this result did not reach significance. CONCLUSIONS: These findings add to the growing body of evidence that daily oral care as a means of primary source control may have a role in NV-HAP prevention. The implementation of effective strategies to ensure that such care is consistently provided warrants further study. It's not yet known what degree and frequency of oral care are required to effect favorable changes in the oral microbiome during acute care hospitalization.

Pulmonary Microbiome of Patients Receiving Mechanical Ventilation: Changes Over Time.

BACKGROUND: Interest in the pulmonary microbiome is growing, particularly in patients undergoing mechanical ventilation. OBJECTIVES: To explore the pulmonary microbiome over time in patients undergoing prolonged mechanical ventilation and to evaluate the effect of an oral suctioning intervention on the microbiome. METHODS: This descriptive subanalysis from a clinical trial involved a random sample of 16 participants (7 intervention, 9 control) who received mechanical ventilation for at least 5 days. Five paired oral and tracheal specimens were evaluated for each participant over time. Bacterial DNA from the paired specimens was evaluated using 16S rRNA gene sequencing. Bacterial taxonomy composition, α-diversity (Shannon index), and ß-diversity (Morisita-Horn index) were calculated and compared within and between participants. RESULTS: Participants were predominantly male (69%) and White (63%), with a mean age of 58 years, and underwent mechanical ventilation for a mean of 9.36 days. Abundant bacterial taxa included Prevotella, Staphylococcus, Streptococcus, Stenotrophomonas, and Veillonella. Mean tracheal α-diversity decreased over time for the total group (P = .002) and the control group (P = .02). ß-Diversity was lower (P = .04) in the control group (1.905) than in the intervention group (2.607). CONCLUSIONS: Prolonged mechanical ventilation was associated with changes in the pulmonary microbiome, with the control group having less diversity. The oral suctioning intervention may have reduced oral-tracheal bacterial transmission.

Intubation Setting, Aspiration, and Ventilator-Associated Conditions.

BACKGROUND: Patients experience endotracheal intubation in various settings with wide-ranging risks for postintubation complications such as aspiration and ventilator-associated conditions. OBJECTIVES: To evaluate associations between intubation setting, presence of aspiration biomarkers, and clinical outcomes. METHODS: This study is a subanalysis of data from the NO-ASPIRATE single-blinded randomized clinical trial. Data were prospectively collected for 513 adult patients intubated within 24 hours of enrollment. Patients with documented aspiration events at intubation were excluded. In the NO-ASPIRATE trial, intervention patients received enhanced oropharyngeal suctioning every 4 hours and control patients received sham suctioning. Tracheal specimens for α-amylase and pepsin tests were collected upon enrollment. Primary outcomes were ventilator hours, lengths of stay, and rates of ventilator-associated conditions. RESULTS: Of the baseline tracheal specimens, 76.4% were positive for α-amylase and 33.1% were positive for pepsin. Proportions of positive tracheal α-amylase and pepsin tests did not differ significantly between intubation locations (study hospital, transfer from other hospital, or field intubation). No differences were found for ventilator hours or lengths of stay. Patients intubated at another hospital and transferred had significantly higher ventilator-associated condition rates than did those intubated at the study hospital (P = .02). Ventilator-associated condition rates did not differ significantly between patients intubated in the field and patients in other groups. CONCLUSIONS: Higher ventilator-associated condition rates associated with interhospital transfer may be related to movement from bed, vehicle loading and unloading, and transport vehicle vibrations. Airway assessment and care may also be suboptimal in the transport environment.

Impact of deep oropharyngeal suctioning on microaspiration, ventilator events, and clinical outcomes: A randomized clinical trial.

AIMS: To evaluate a deep oropharyngeal suction intervention (NO-ASPIRATE) in intubated patients on microaspiration, ventilator-associated events and clinical outcomes. DESIGN: Prospective, two-group, single-blind, randomized clinical trial. METHODS: The study was conducted between 2014 - 2017 in 513 participants enroled within 24 hr of intubation and randomized into NO-ASPIRATE or usual care groups. Standard oral care was provided to all participants every 4 hr and deep oropharyngeal suctioning was added to the NO-ASPIRATE group. Oral and tracheal specimens were obtained to quantify α-amylase as an aspiration biomarker. RESULTS: Data were analysed for 410 study completers enrolled at least 36 hr: NO-ASPIRATE (N = 206) and usual care (N = 204). Percent of tracheal specimens positive for α-amylase, mean tracheal α-amylase levels over time and ventilator-associated events were not different between groups. The NO-ASPIRATE group had a shorter hospital length of stay and a subgroup with moderate aspiration at baseline had significantly lower α-amylase levels across time. CONCLUSION: Hospital length of stay was shorter in the NO-ASPIRATE group and a subgroup of intervention participants had lower α-amylase across time. Delivery of standardized oral care to all participants may have been an intervention itself and possibly associated with the lack of significant findings for most outcomes. IMPACT: This trial compared usual care to oral care with a deep suctioning intervention on microaspiration and ventilator-associated events, as this has not been systematically studied. Further research on the usefulness of α-amylase as an aspiration biomarker and the role of oral suctioning, especially for certain populations, is indicated. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov: NCT02284178.

Nursing oral suction intervention to reduce aspiration and ventilator events (NO-ASPIRATE): A randomized clinical trial.

AIM: The primary aim of this study is to compare an oropharyngeal suction intervention versus usual care on microaspiration in intubated patients. Secondary aims are to evaluate the intervention on ventilator-associated condition rates, time to occurrence and compare tracheal-oral α-amylase ratios between groups. DESIGN: Prospective randomized clinical trial. METHODS: The study received funding from the National Institutes of Health in February 2014 and Institutional Review Board approval in July 2013. Over 4 years, a convenience sample of 600 orally intubated, ventilated adult patients will be enrolled within 24 hr of intubation. The target sample is 400 participants randomized to the two groups. The intervention involves enhanced suctioning of the mouth and oropharynx every 4 hr, while the usual care group receives a sham suctioning. The research team will deliver usual oral care to all patients every 4 hr and collect oral and tracheal specimens every 12 hr, to quantify α-amylase levels to detect aspiration of oral secretions. Study completers must be enrolled at least 36 hr (baseline and three paired samples). Outcomes include α-amylase levels, percent of positive specimens, ventilator-associated conditions, length of stay, ventilator hours, and discharge disposition. DISCUSSION: Enrolment has closed, and data analysis has begun. Subgroup analyses emerged, contributing to future research knowledge. IMPACT: Standardized interventions have reduced but do not address all risk factors associated with ventilator-associated conditions. This study provides the potential to reduce microaspiration and associated sequelae in critically ill, intubated patients.

Collecting Nursing Research Data 24 Hours a Day: Challenges, Lessons, and Recommendations.

BACKGROUND: Research on many routine nursing interventions requires data collection around the clock each day (24/7). Strategies for implementing and coordinating a study 24/7 are not discussed in the literature, and best practices are needed. OBJECTIVE: To identify strategies incorporated into implementing a nursing intervention trial 24/7, including key lessons learned. METHODS: Strategies to facilitate implementation of a clinical trial of a nursing intervention with patients undergoing mechanical ventilation are shared. Challenges and changes for future studies also are discussed. RESULTS: Adequate planning, including a detailed operations manual, guides study implementation. Staffing is the most challenging and costly part of a study but is essential to a study's success. Other important strategies include communication among the study personnel and with collaborators and direct care staff. An electronic method of recording study-related data also is essential. CONCLUSIONS: A nursing clinical trial that requires interventions on a 24/7 basis can be done with thorough planning, staffing, and continuous quality improvement activities.

Enrollment Challenges in Critical Care Nursing Research.

BACKGROUND: Enrollment challenges for critical care research are common. Contributing factors include short enrollment windows, the crisis nature of critical illness, lack of research staff, unavailable legal proxy, family dynamics, and language barriers. OBJECTIVE: To describe enrollment statistics for an ongoing critical care nursing trial, barriers to recruitment, and strategies to enhance enrollment. METHODS: Two years' worth of recruitment and enrollment data from an oral care intervention trial in critically ill adults receiving mechanical ventilation at 1 hospital were analyzed. Recruitment logs include number of patients screened, eligible, enrolled, and declined and patients' sex, race, and ethnicity. RESULTS: Target enrollment (15.5 patients per month) was based on experience and historical data. Strategies implemented to promote enrollment included providing study personnel at least 18 hours per day for 7 days per week, regular rounds, communication with direct care staff, and Spanish consent processes. In 2 years, 6963 patients were screened; 1551 (22%) were eligible. Consent was sought from 366 (24% of eligible patients). Enrollment averaged 13.3 patients per month (86% of projected target). The main factor impeding enrollment was unavailability of a legal proxy to provide consent (88%). The refusal rates of white (11%), black (13%), and Hispanic (16%) patients did not differ significantly. However, those classified as Asian or as more than 1 race declined significantly more often (35%) than did white or black patients (P = .02). CONCLUSIONS: Unavailability of a legal proxy within a short enrollment window was the major challenge to enrollment. Various factors influenced consent decisions. Clinical study design requires more conservative estimates.

Pepsin and amylase in oral and tracheal secretions: a pilot study.

BACKGROUND: Endotracheal intubation increases the risk for microaspiration of secretions around the tube cuff. Pepsin has been used as a biomarker for gastric aspiration. Amylase is a newer proposed biomarker for aspiration of oral contents. OBJECTIVE: To assess the presence of pepsin and amylase in paired oral-tracheal secretions of adult patients treated with mechanical ventilation. METHODS: In this descriptive study, paired samples of oral and tracheal secretions were obtained from adult patients at baseline and again within 4 hours when a need for endotracheal suctioning was assessed. Assays of pepsin and amylase were processed in a specialty diagnostic laboratory. RESULTS: The sample consisted of 10 men and 3 women with a median age of 56 years. The majority were intubated with a subglottic suction endotracheal tube (9 patients, 69%), receiving synchronized intermittent mandatory ventilation (10 patients; 77%), and receiving enteral feedings (11 patients; 85%) through a tube distally placed in the stomach (8 patients; 67%). Pepsin was present in oral secretions of 9 patients (69%), and in tracheal specimens of 7 patients (54%) at one or both sampling times. Amylase was detected in all patients' oral secretions and in tracheal secretions of 5 patients (38%) at one or both sampling times. CONCLUSIONS: Many patients had pepsin, amylase, or both in tracheal aspirates. Pepsin was more commonly detected than was amylase. Although the relationship of this finding to long-term outcomes was not assessed, findings indicate that microaspiration of oral and gastric secretions occurs frequently.

The dispersal process of asexual propagules and the contribution to population persistence in Marchantia (Marchantiaceae).

PREMISE OF THE STUDY: The dispersal process involves emigration from a focal source, dispersal through the landscape, and immigration into a new population or habitat. Despite the fact that dispersal is vital for the long-term persistence of a species, key stages of the process are unknown or understudied for many species, including the importance and contribution of asexual reproduction. Focusing only on a single stage in the dispersal process may give an incomplete and potentially flawed picture of the effects of asexual reproduction on metapopulation dynamics in plant species. METHODS: Using a multifaceted approach that combines laboratory experiments, field studies, and mathematical models, we quantify the production, dispersal, and survival of immigrants of water-dispersed asexual offspring (gemmae) of the clonal liverwort Marchantia inflexa. KEY RESULTS: Compared to female plants, male plants of Marchantia inflexa produce gemmae more quickly and in higher numbers, but due to desiccation have lower gemmae survival rates. Gemmae move up to 20 cm per minute in light rain, suggesting they can leave the source population. Long distance dispersal of gemmae is supported by the mathematical analysis of unisexual metapopulations. Upon reaching the new habitat, gemmae survival is high if they stay moist. CONCLUSIONS: By integrating multiple experiments to quantify the effects of gemmae on metapopulation dynamics, we found that different stages of dispersal can lead to different conclusions on which sex has an advantage. Gemmae are critical for the maintenance of both sexes, the persistence of single-sex metapopulations and species, and the invasibility of clonal organisms.