UNLABELLED: Medical alarm signals are important for alerting clinicians to life-threatening conditions, but the high rate of false alarms can be problematic. Reduction in alarm signals may lead to increased staff responsiveness to alarms and create a quieter environment for patients. The effect of these changes on patient outcomes is uncertain. METHODS: We conducted a pilot, prospective, randomized, controlled trial in the cardiac care unit (CCU) to test a study protocol and data collection instruments and to examine the differences in alarms between usual care and altered settings. Subjects were randomized daily to either standard or altered CCU alarm settings. Secondary outcomes included the number of clinically significant events (CSEs) detected, event-triggered interventions (ETIs), frequency of alarms per monitored bed, and patient complications. RESULTS: Over the two-week study time frame, 22 unique patients were enrolled. There were 1,710 alarms over 163 hours of monitoring in the standard group and 1,165 alarms over 169 hours in the study group (P < 0.001). There were more CSEs detected (14 vs. 3) and ETIs (12 vs. 2) in the study group, but sample size was too small to determine efficacy. No cardiac arrests or adverse patient outcomes were observed in either group. All patients were discharged from the hospital. Study protocol and outcomes were feasible and lessons were learned. CONCLUSION: This study demonstrated feasibility of a study protocol for conducting a randomized controlled trial to evaluate CSEs, ETIs, frequency of alarms, and adverse patient outcomes when altering default alarm settings. A longer study can be performed using a similar study design.
RCT Entities:
UNLABELLED: Medical alarm signals are important for alerting clinicians to life-threatening conditions, but the high rate of false alarms can be problematic. Reduction in alarm signals may lead to increased staff responsiveness to alarms and create a quieter environment for patients. The effect of these changes on patient outcomes is uncertain. METHODS: We conducted a pilot, prospective, randomized, controlled trial in the cardiac care unit (CCU) to test a study protocol and data collection instruments and to examine the differences in alarms between usual care and altered settings. Subjects were randomized daily to either standard or altered CCU alarm settings. Secondary outcomes included the number of clinically significant events (CSEs) detected, event-triggered interventions (ETIs), frequency of alarms per monitored bed, and patient complications. RESULTS: Over the two-week study time frame, 22 unique patients were enrolled. There were 1,710 alarms over 163 hours of monitoring in the standard group and 1,165 alarms over 169 hours in the study group (P < 0.001). There were more CSEs detected (14 vs. 3) and ETIs (12 vs. 2) in the study group, but sample size was too small to determine efficacy. No cardiac arrests or adverse patient outcomes were observed in either group. All patients were discharged from the hospital. Study protocol and outcomes were feasible and lessons were learned. CONCLUSION: This study demonstrated feasibility of a study protocol for conducting a randomized controlled trial to evaluate CSEs, ETIs, frequency of alarms, and adverse patient outcomes when altering default alarm settings. A longer study can be performed using a similar study design.
Authors: Richard L Fidler; Michele M Pelter; Barbara J Drew; Jorge Arroyo Palacios; Yong Bai; Daphne Stannard; J Matt Aldrich; Xiao Hu Journal: PLoS One Date: 2017-11-27 Impact factor: 3.240
Authors: Daniel C McFarlane; Alexa K Doig; James A Agutter; Lara M Brewer; Noah D Syroid; Ranjeev Mittu Journal: PLoS One Date: 2018-05-16 Impact factor: 3.240