RESUMEN
Rationale: Enteral nutrition is beneficial for stroke patients with oral intake difficulties. However, it is time consuming and may interfere with routine medical care. Therefore, there is a clinical benefit if enteral nutrition can be safely administered in a short time. Although our retrospective study showed the safety of rapid administration, it remains unclear whether rapid administration of enteral nutrition is as safe as conventional administration. Aim: The randomized study of Enteral Nutrition with Rapid versus conventional administration in acute stroke patients (Rapid EN trial) aims to clarify the safety of rapid feeding of enteral nutrition compared with conventional feeding. Methods and design: This is an investigator-initiated, multicenter, prospective, randomized, open-label, blinded end-point clinical trial. Eligible criteria include acute stroke patients who have difficulty with oral intake defined as severe altered consciousness (Japan Coma Scale 10-300) or modified water swallowing test <4. The target enrollment is 700 patients, with 350 patients receiving rapid enteral nutrition at a rate of 100 mL in 5 min (Rapid EN group) and 350 patients receiving conventional enteral nutrition at a rate of 100 mL in 30 min (Conventional EN group). Study outcome: The primary outcome is the incidence of one or more complications of vomiting or diarrhea or pneumonia within 7 days would be non-inferior in the rapid EN group compared to the conventional EN group. Secondary outcomes were total time spent on enteral nutrition within 7 days from enteral nutrition, the incidence of vomiting, diarrhea and pneumonia within 3 or 7 days, and the rate of favorable clinical outcome. Discussion: Since no previous reports have focused on the speed of administration, we felt it was necessary to prove the safety of rapid administration. If this study shows positive results, it will not only benefit patients, but also reduce the burden of medical care. We believe this study is novel and will be useful in clinical practice. Clinical trial registration: https://rctportal.niph.go.jp/s/detail/um?trial_id=UMIN000046610 Identifier UMIN000046610.
RESUMEN
OBJECTIVES: Since patients with stroke frequently develop bladder dysfunction, a careful approach is required to reduce unnecessary indwelling urinary catheter (IUC) for preventing catheter-associated urinary tract infection (CAUTI). This study aimed to assess the effectiveness and safety of a program to promote appropriate IUC use in stroke care. METHODS: We conducted a prospective interrupted time series study in three tertiary care hospitals in Japan. Adult patients with acute stroke were eligible. The study consisted of three phases: baseline, education and implementation. Our program included an assessment of IUC indications, educational meetings among healthcare professionals, reminders for removal of inappropriate IUC and a urinary retention protocol. The primary outcome was the proportion of inappropriate IUC use to assess effectiveness. The device utilization ratio and incidence of CAUTI were examined to assess effectiveness, and incidences of urinary retention and all symptomatic urinary tract infection (UTI) were examined to assess safety. RESULTS: Among 976 patients who met the inclusion criteria, 738 were analysed. Inappropriate IUC use decreased from 50.1% in the baseline phase to 22.5% in the implementation phase (absolute risk reduction in interrupted time series analysis 42.4% [95% confidence interval, 19.2%-65.6%]). The device utilization ratio decreased from 0.302 to 0.194 (p < 0.001), whereas CAUTI did not change significantly (from 8.81 to 8.28 per 1000 catheter-days; incidence rate ratio 0.95 [0.44-1.94]). All symptomatic UTI decreased from 9.5% to 4.9% (p = 0.015), with no increase in urinary retention. CONCLUSIONS: Our program improved the appropriateness of IUC use in stroke care while ensuring safety.
