Trend in Clinical Trial Participation During COVID-19: A Secondary Analysis of the I-SPY COVID Clinical Trial.

To analyze the temporal trend in enrollment rates in a COVID-19 platform trial during the first three waves of the pandemic in the United States. DESIGN: Secondary analysis of data from the I-SPY COVID randomized controlled trial (RCT). SETTING: Thirty-one hospitals throughout the United States. PATIENTS: Patients who were approached, either directly or via a legally authorized representative, for consent and enrollment into the I-SPY COVID RCT. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Among 1,338 patients approached for the I-SPY COVID trial from July 30, 2020, to February 17, 2022, the number of patients who enrolled (n = 1,063) versus declined participation (n = 275) was used to calculate monthly enrollment rates. Overall, demographic and baseline clinical characteristics were similar between those who enrolled versus declined. Enrollment rates fluctuated over the course of the COVID-19 pandemic, but there were no significant trends over time (Mann-Kendall test, p = 0.21). Enrollment rates were also comparable between vaccinated and unvaccinated patients. In multivariable logistic regression analysis, age, sex, region of residence, COVID-19 severity of illness, and vaccination status were not significantly associated with the decision to decline consent. CONCLUSIONS: In this secondary analysis of the I-SPY COVID clinical trial, there was no significant association between the enrollment rate and time period or vaccination status among all eligible patients approached for clinical trial participation. Additional studies are needed to better understand whether the COVID-19 pandemic has altered clinical trial participation and to develop strategies for encouraging participation in future COVID-19 and critical care clinical trials.

Perceived Hospital Stress, Severe Acute Respiratory Syndrome Coronavirus 2 Activity, and Care Process Temporal Variance During the COVID-19 Pandemic.

OBJECTIVES: The COVID-19 pandemic threatened standard hospital operations. We sought to understand how this stress was perceived and manifested within individual hospitals and in relation to local viral activity. DESIGN: Prospective weekly hospital stress survey, November 2020-June 2022. SETTING: Society of Critical Care Medicine's Discovery Severe Acute Respiratory Infection-Preparedness multicenter cohort study. SUBJECTS: Thirteen hospitals across seven U.S. health systems. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: We analyzed 839 hospital-weeks of data over 85 pandemic weeks and five viral surges. Perceived overall hospital, ICU, and emergency department (ED) stress due to severe acute respiratory infection patients during the pandemic were reported by a mean of 43% ( sd , 36%), 32% (30%), and 14% (22%) of hospitals per week, respectively, and perceived care deviations in a mean of 36% (33%). Overall hospital stress was highly correlated with ICU stress (ρ = 0.82; p < 0.0001) but only moderately correlated with ED stress (ρ = 0.52; p < 0.0001). A county increase in 10 severe acute respiratory syndrome coronavirus 2 cases per 100,000 residents was associated with an increase in the odds of overall hospital, ICU, and ED stress by 9% (95% CI, 5-12%), 7% (3-10%), and 4% (2-6%), respectively. During the Delta variant surge, overall hospital stress persisted for a median of 11.5 weeks (interquartile range, 9-14 wk) after local case peak. ICU stress had a similar pattern of resolution (median 11 wk [6-14 wk] after local case peak; p = 0.59) while the resolution of ED stress (median 6 wk [5-6 wk] after local case peak; p = 0.003) was earlier. There was a similar but attenuated pattern during the Omicron BA.1 subvariant surge. CONCLUSIONS: During the COVID-19 pandemic, perceived care deviations were common and potentially avoidable patient harm was rare. Perceived hospital stress persisted for weeks after surges peaked.

Failure of surface-modified bypass circuits to improve platelet function during pediatric cardiac surgery.

OBJECTIVE: Surface-modified cardiopulmonary bypass circuits have been shown to improve platelet function and decrease postoperative bleeding after heart surgery in adults. Two surface-modified cardiopulmonary bypass circuits are approved and commercially available for pediatric cardiac surgery. There have been few studies demonstrating the efficacy of these modifications for children. We performed a prospective, randomized trial comparing surface-modified cardiopulmonary bypass circuits to a standard unmodified circuit in pediatric cardiac surgery. METHODS: Sixty-nine children (median 6 months old) undergoing first-time cardiac surgery were enrolled and randomized to an uncoated circuit or one of the two commercially available surface modified circuits for their operation. Blood samples were collected at baseline, on cardiopulmonary bypass, at the end of rewarming, after protamine, and at 18 to 24 postoperative hours. Platelet count, beta-thromboglobulin, and thromboelastography with and without abciximab were measured. Postoperative chest tube outputs and blood product utilization were also analyzed. RESULTS: The platelet counts, beta-thromboglobulin levels, thromboelastographic measures of platelet function, and postoperative bleeding were not significantly different between the surface-modified cardiopulmonary bypass circuit groups and the control group. CONCLUSION: Currently available surface-modified cardiopulmonary bypass circuits do not significantly improve platelet function or clinical outcomes after routine pediatric cardiac surgery.

Protocol-driven ventilator management in children: comparison to nonprotocol care.

The purpose of this study was to compare ventilator weaning time, time to spontaneous breathing, and overall ventilator hours duration with use of a ventilator management protocol (VMP) versus standard nonprotocol-based care in a pediatric intensive care unit. A multidisciplinary task force developed a comprehensive protocol for ventilator management with four specific phases: initial ventilator set up and adjustment, weaning, minimal settings, and spontaneous mode prior to extubation. Medical records of ventilated patients both before and after protocol implementation were reviewed. A total of 187 patients were studied (89 nonprotocol and 98 VMP patients). No differences were seen between groups in PRISM scores, Murray scores, or oxygenation indices, but VMP patients were significantly younger (P =.03). Ventilator weaning times (P =.005) and time to spontaneous breathing modes (P =.006) were significantly decreased in VMP patients compared to nonprotocol patients, but overall ventilator duration was not significantly different. No significant differences were seen in extubation failure, use of corticosteroids, or use of racemic epinephrine between groups. Use of an institution-specific VMP developed by a multidisciplinary team was associated with significantly reduced ventilator weaning time and time to spontaneous breathing. Further studies are needed.