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.

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.