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Assessing the Impact of Monitor Maintenance Package Utilization

Assessing the Impact of Monitor Maintenance Package Utilization on Patient Monitor Alarms and Nurse Alarm Fatigue

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06403397
Enrollment
142
Registered
2024-05-07
Start date
2024-06-15
Completion date
2024-12-15
Last updated
2024-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alarm Fatigue, Patient Safety

Keywords

alarm fatigue, Intensive care unit, Nurse-driven monitoring bundle, patient safety

Brief summary

Bedside monitors are frequently used in monitoring vital signs of critically ill patients. Nurses working in healthcare facilities, especially in intensive care units, are required to manage devices with different alarm threshold values, categories, and types of alerts, leading to alarm fatigue. In response to this serious threat to patient safety, the FDA and The Joint Commission worked to develop strategies to address alarm fatigue in 2011. Alarm monitoring, identification of the cause, and silencing are typically performed by nurses. When reviewing alarm control studies in the literature, the CEASE care package developed by Levis et al. in 2019 was encountered. The tool was developed for personalized clinical alarm monitoring for the patient.

Detailed description

Bedside monitors are frequently used in monitoring vital signs of critically ill patients. Patient monitors assist healthcare professionals in continuous monitoring of basic vital signs such as EKG (electrocardiogram), blood pressure, pulse oximetry, respiration, as well as advanced hemodynamic parameters like central venous pressure, pulmonary artery pressure. These devices alert healthcare personnel visually and audibly in case of any abnormality in the monitored parameters. According to the Sentinel Event Alert report published by The Joint Commission (TJC) in 2013, each unit can receive thousands of alarm alerts in a single day. It is stated that 85% to 99% of these alarms are either not related to the patient's clinical condition, false, or do not require any action. This situation leads to necessary alarms being silenced, ignored, or muted, thereby threatening patient safety. Thousands of patient injuries and deaths have been reported due to alarm system errors. The main reasons for alarm errors include failure to recognize the alarm, desensitization in nurses, inadequate training in monitor usage, decreased response time to alarms, deficiencies in device interface design, equipment failures, and staff shortages. Monitor alarms occur in a hierarchy of high, medium, and low priority. Each hierarchical alarm produces a different auditory tone. Clinicians use these alarm tones to determine the urgency level and appropriate alarm response. When clinically irrelevant alarms occur more frequently, there is a higher likelihood of overall alarm fatigue. Nurses working in healthcare facilities, especially in intensive care units, are required to manage devices with different alarm threshold values, categories, and types of alerts, leading to alarm fatigue. Alarm fatigue is defined as healthcare workers becoming desensitized and indifferent to many recurring or simultaneous alarm sounds. In response to this serious threat to patient safety, the FDA and The Joint Commission worked to develop strategies to address alarm fatigue in 2011. The published report emphasizes the need to identify the problem clinically and develop solution strategies tailored to the problem, to be implemented alongside general standard interventions. The report primarily focuses on adjusting alarm parameters appropriately and establishing clinic-specific protocols and procedures. Alarm monitoring, identification of the cause, and silencing are typically performed by nurses. When reviewing alarm control studies in the literature, the CEASE care package developed by Levis et al. in 2019 was encountered. The tool was developed for personalized clinical alarm monitoring for the patient. The name CEASE is formed by combining the initials of the words Communication, Electrodes, Appropriateness, Setup, and Education. Researchers found a decrease in the number of monitor alarms and alarm fatigue levels in nurses after using the CEASE care package. More supportive studies are needed for the widespread adoption of this package in clinics. In this study, the investigators aimed to demonstrate a reduction in unnecessary alarm counts and a decrease in nurse alarm fatigue levels with the use of the CEASE care package.

Interventions

OTHERExperimental group: CEASE Care Package and Remember Me Tool

Before the intervention, the intervention group will first undergo the 'Nurse Identification Form' and the 'Alarm Fatigue Scale'. The current root cause analysis of monitor alarms in the clinical setting will be conducted through the 'CEASE Care Package' and the 'Current Situation Analysis Form'. Each patient monitor in the intensive care unit will be observed and recorded by two observers for a period of 24 hours.The Monitor Alarm Control Tool - Remember Me will be attached beneath each monitor to facilitate easier monitoring by nurses. Nurses are expected to use the tool for a period of 15 days. After intervention; Two observers will conduct a re-evaluation using the CEASE Care Package and the Current Status Analysis Form. Monitor alarms will be continuously assessed and recorded for 24 hours. Following the completion of this stage, the Alarm Fatigue Scale will be reapplied to the intervention group.

Sponsors

Istanbul Demiroglu Bilim University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)

Masking description

The population of the study consists of all nurses working in the intensive care units of Prof. Dr. Cemil Taşcıoğlu City Hospital. There are a total of 142 nurses working in the adult intensive care units of the hospital.

Intervention model description

This study is a cross-controlled experimental research conducted to determine the effect of using the CEASE care package on patient monitor alarms and nurse alarm fatigue in adult intensive care units

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Working in the intensive care unit, * Willing to participate in the study voluntarily, * Nurses willing to use the monitor alarm control tool (for intervention group).

Exclusion criteria

* Nurses who leave the intensive care unit during the data collection process and those who do not use the monitor alarm control tool

Design outcomes

Primary

MeasureTime frameDescription
The use of the CEASE care package tool will result in a decrease in the number of alarms in the intensive care unit end of the 3 weeks.2 monthsThis outcome will measured by Current Situation Analysis Form and CEASE care package tool.
The use of the CEASE care package tool will lead to a reduction in alarm fatigue levels end of the 3 weeks.2 monthsThis outcome will measured by alarm fatigue scale.

Countries

Turkey (Türkiye)

Contacts

Primary ContactSerpil Topçu
serpilakkustopcu@gmail.com05324676179

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026