Alarm FatigueNCT06403397
Assessing the Impact of Monitor Maintenance Package Utilization
A study testing Experimental group: CEASE Care Package and Remember Me Tool in people with Alarm Fatigue and Patient Safety, run by Istanbul Demiroglu Bilim University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alarm Fatigue, Patient Safety
- What is being tested?
- Experimental group: CEASE Care Package and Remember Me Tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2024to 15 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Nurses who leave the intensive care unit during the data collection process and those who do not use the monitor alarm control tool
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Demiroğlu Bilim University
Istanbul, Şişli, 34394
About this study
Official title: Assessing the Impact of Monitor Maintenance Package Utilization on Patient Monitor Alarms and Nurse Alarm Fatigue
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.
Read the 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.
- Conditions
- Alarm Fatigue, Patient Safety
- Being tested
- Experimental group: CEASE Care Package and Remember Me Tool
- Keywords
- alarm fatigue, Intensive care unit, Nurse-driven monitoring bundle, patient safety
- Medical subject headings
- Alert Fatigue, Health Personnel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental group: CEASE Care Package and Remember Me ToolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | * Working in the intensive care unit,
* Willing to participate in the study voluntarily,
* Nurses willing to use the monitor alarm control tool. Receives: Other: Experimental group: CEASE Care Package and Remember Me Tool |
| Control group | No intervention | * Working in the intensive care unit, * Willing to participate in the study voluntarily, |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
This outcome will measured by Current Situation Analysis Form and CEASE care package tool.
Measured: 2 months
The use of the CEASE care package tool will lead to a reduction in alarm fatigue levels end of the 3 weeks.
This outcome will measured by alarm fatigue scale.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start15 Jun 2024
- Primary completion15 Mar 2025
- Study completion15 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Alarm FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Demiroglu Bilim University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ogretim Uyesi Serpil Topcu, Istanbul Demiroglu Bilim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06403397
- Sponsor's protocol ID
- Remember Me Tool
- Status last verified
- May 2024
- First submitted
- 29 Apr 2024
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Researchers may share IPD data after the completion and publication of the study.
Publications
Schmid F, Goepfert MS, Reuter DA. Patient monitoring alarms in the ICU and in the operating room. Crit Care. 2013 Mar 19;17(2):216. doi: 10.1186/cc12525. No abstract available.
PubMed 23510435Joint Commission. Medical device alarm safety in hospitals. Sentinel Event Alert. 2013 Apr 8;(50):1-3. No abstract available.
PubMed 23767076De Vaux L, Cooper D, Knudson K, Gasperini M, Rodgerson K, Funk M. Reduction of Nonactionable Alarms in Medical Intensive Care. Biomed Instrum Technol. 2017 Feb;51(s2):58-61. doi: 10.2345/0899-8205-51.s2.58. No abstract available.
PubMed 28296452Clark, T., David, Y., & Baretich, M. Impact of clinical alarms on patient safety. ACCE Healthcare Technology Foundation 2006: 1-20
Sendelbach S, Funk M. Alarm fatigue: a patient safety concern. AACN Adv Crit Care. 2013 Oct-Dec;24(4):378-86; quiz 387-8. doi: 10.1097/NCI.0b013e3182a903f9.
PubMed 24153215Graham KC, Cvach M. Monitor alarm fatigue: standardizing use of physiological monitors and decreasing nuisance alarms. Am J Crit Care. 2010 Jan;19(1):28-34; quiz 35. doi: 10.4037/ajcc2010651.
PubMed 20045845Association for the Advancement of Medical Instrumentation (2011). A siren call to action: Priority issues from the medical device alarms summit. Clinical Alarms AAMI Summit Proceedings, 5(6).
Cvach M. Monitor alarm fatigue: an integrative review. Biomed Instrum Technol. 2012 Jul-Aug;46(4):268-77. doi: 10.2345/0899-8205-46.4.268.
PubMed 22839984Erbay-Dalli O, Bagci-Derinpinar K. Adaptation and validation of the Turkish version of the alarm fatigue assessment questionnaire. Enferm Intensiva (Engl Ed). 2024 Apr-Jun;35(2):114-123. doi: 10.1016/j.enfie.2023.09.001. Epub 2023 Oct 5.
PubMed 37805362Alarm management. Crit Care Nurse. 2013 Oct;33(5):83-6. No abstract available.
PubMed 24085833Ashrafi, S., Najafi Mehri, S., & Nehrir, B. (2017). Designing an Alarm Fatigue Assessment Questionnaire: Evaluation of the Validity and Reliability of an Instrument. Journal of Critical Care Nursing, 10(4), 0-0.
Lewis CL, Oster CA. Research Outcomes of Implementing CEASE: An Innovative, Nurse-Driven, Evidence-Based, Patient-Customized Monitoring Bundle to Decrease Alarm Fatigue in the Intensive Care Unit/Step-down Unit. Dimens Crit Care Nurs. 2019 May/Jun;38(3):160-173. doi: 10.1097/DCC.0000000000000357.
PubMed 30946125Topcu S, Sari MK, Yilmaz MS, Urkmez DO. Improving nurses' alarm-management performance with a behavioral reminder. Rev Esc Enferm USP. 2026 Sep 21;60:e20250579. doi: 10.1590/1980-220X-REEUSP-2025-0579en. eCollection 2026.
PubMed 42771604
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of Monitor Maintenance Package Utilization on Patient Monitor Alarms and Nurse Alarm Fatigue
- ClinicalTrials.gov ID
- NCT06403397
- Acronym / sponsor ID
- Remember Me Tool
- Conditions
- Alarm Fatigue, Patient Safety
- Keywords
- alarm fatigue, Intensive care unit, Nurse-driven monitoring bundle, patient safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Istanbul Demiroglu Bilim UniversityUniversity, hospital or other
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 7 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Experimental group: CEASE Care Package and Remember Me Tool* Working in the intensive care unit, * Willing to participate in the study voluntarily, * Nurses willing to use the monitor alarm control tool. |
| Control group | No intervention | –* Working in the intensive care unit, * Willing to participate in the study voluntarily, |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (1 listed)
- Nurses who leave the intensive care unit during the data collection process and those who do not use the monitor alarm control tool
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental group: CEASE Care Package and Remember Me ToolBefore 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. | Other | Experimental group |
Primary outcome
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.
Time frame: 2 months
This 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.
Time frame: 2 months
This outcome will measured by alarm fatigue scale.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Background: PubMed 23510435Schmid F, Goepfert MS, Reuter DA. Patient monitoring alarms in the ICU and in the operating room. Crit Care. 2013 Mar 19;17(2):216. doi: 10.1186/cc12525. No abstract available.
- Background: PubMed 23767076Joint Commission. Medical device alarm safety in hospitals. Sentinel Event Alert. 2013 Apr 8;(50):1-3. No abstract available.
- Background: PubMed 28296452De Vaux L, Cooper D, Knudson K, Gasperini M, Rodgerson K, Funk M. Reduction of Nonactionable Alarms in Medical Intensive Care. Biomed Instrum Technol. 2017 Feb;51(s2):58-61. doi: 10.2345/0899-8205-51.s2.58. No abstract available.
- BackgroundClark, T., David, Y., & Baretich, M. Impact of clinical alarms on patient safety. ACCE Healthcare Technology Foundation 2006: 1-20
- Background: PubMed 24153215Sendelbach S, Funk M. Alarm fatigue: a patient safety concern. AACN Adv Crit Care. 2013 Oct-Dec;24(4):378-86; quiz 387-8. doi: 10.1097/NCI.0b013e3182a903f9.
- Background: PubMed 20045845Graham KC, Cvach M. Monitor alarm fatigue: standardizing use of physiological monitors and decreasing nuisance alarms. Am J Crit Care. 2010 Jan;19(1):28-34; quiz 35. doi: 10.4037/ajcc2010651.
- BackgroundAssociation for the Advancement of Medical Instrumentation (2011). A siren call to action: Priority issues from the medical device alarms summit. Clinical Alarms AAMI Summit Proceedings, 5(6).
- Background: PubMed 22839984Cvach M. Monitor alarm fatigue: an integrative review. Biomed Instrum Technol. 2012 Jul-Aug;46(4):268-77. doi: 10.2345/0899-8205-46.4.268.
- Background: PubMed 37805362Erbay-Dalli O, Bagci-Derinpinar K. Adaptation and validation of the Turkish version of the alarm fatigue assessment questionnaire. Enferm Intensiva (Engl Ed). 2024 Apr-Jun;35(2):114-123. doi: 10.1016/j.enfie.2023.09.001. Epub 2023 Oct 5.
- Background: PubMed 24085833Alarm management. Crit Care Nurse. 2013 Oct;33(5):83-6. No abstract available.
- BackgroundAshrafi, S., Najafi Mehri, S., & Nehrir, B. (2017). Designing an Alarm Fatigue Assessment Questionnaire: Evaluation of the Validity and Reliability of an Instrument. Journal of Critical Care Nursing, 10(4), 0-0.
- Background: PubMed 30946125Lewis CL, Oster CA. Research Outcomes of Implementing CEASE: An Innovative, Nurse-Driven, Evidence-Based, Patient-Customized Monitoring Bundle to Decrease Alarm Fatigue in the Intensive Care Unit/Step-down Unit. Dimens Crit Care Nurs. 2019 May/Jun;38(3):160-173. doi: 10.1097/DCC.0000000000000357.
- Individual participant dataSharing planned: No. Researchers may share IPD data after the completion and publication of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group: CEASE Care Package and Remember Me Tool in people with Alarm Fatigue and Patient Safety, run by Istanbul Demiroglu Bilim University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06403397, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.