Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06403397
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-04-29
Brief Title:
Assessing the Impact of Monitor Maintenance Package Utilization
Sponsor:
Istanbul Demiroglu Bilim University
Organization:
Istanbul Demiroglu Bilim University
Study Overview
Official Title:
Assessing the Impact of Monitor Maintenance Package Utilization on Patient Monitor Alarms and Nurse Alarm Fatigue
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None