Clinical Trials Logo

Clinical Trial Summary

Patients admitted to the intensive care unit (ICU) undergo complex critical care treatment and are consequently surrounded by equipment and monitors contributing to high sound pressure levels. In addition, many medical and nursing ICU staff members work together with numerous visiting consultants resulting in an additional sound burden. As is already known, in the ICU environment, many activities carried out by healthcare professionals, require a high level of concentration. So, the noisy ICU environment causes interruptions in activities that require concentration and induce in this way, a higher potential for errors. The World Health Organization (WHO) and the Environmental Protection Agency (EPA) set standards for sound levels in hospitals with a recommendation for patient treatment areas. There is a clear trend for increasing hospital noise since the sixties. According to healthcare professionals, one of the strongest contributing factors of noise in the ICU environment are monitoring alarms as they occur very frequently. Additionally, ICU nurses experience high levels of stress towards clinical alarms and are becoming alarm fatigue, which means that the staff becomes desensitized because of an excessive number of alarms and may disable or silence alarms without checking the patient . Consensus dictates the importance of reducing sound pressure levels and the numerous alarm signals from monitor alarms in the ICU. In the study, we focus on busy predetermined areas in the ICU. This study aims to determine the effect of an intervention bundle, aimed at the reduction of "noise" (decibels) and its effect on health care professionals.


Clinical Trial Description

Design: The introduction is done by a stepped wedge cluster randomized design. The study will be carried out in five units of the department of intensive care medicine of the Radboud University Medical Center, a 950-bed university hospital in the Netherlands. The study focus on health care providers in the ICU.The research consists of the introduction of an intervention bundle to reduce noise and therefore interruptions during their daily work activities. Inclusion: All health care providers present at the ICU, during the study period (about 350) are asked to participate. They will recieve information about the aim, content and relevance of the study and will be asked for participation.They are free to refuse to participate in the study (e.g. part of observations, survey). Methods: The data collection focuses on quantitative noise measurements at the predetermined locations in ICU units during the study period. In addition, during the entire study period (control and intervention), we analyse the amount and type of alarms. Thirdly, we collect data with regard to disruptions during the daily work process of healthcare professionals (e.g. during "high-risk moments", such as: medication preparation) by observations. Finally, health care providers are asked about their perceived annoyance, as a result of ambient noise (NRS-annoyance). Data analysis will be supported with the use of Excel, Phyton and SPSS. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04643652
Study type Interventional
Source Radboud University Medical Center
Contact Jeanette Vreman, MSc
Phone 0641247550
Email Jeanette.Vreman@Radboudumc.nl
Status Recruiting
Phase N/A
Start date August 1, 2022
Completion date December 1, 2023

See also
  Status Clinical Trial Phase
Completed NCT04485481 - Single and Multiple Ascending Dose Study of ADX-914 in Healthy Adult Volunteers Phase 1
Completed NCT03473236 - Phase 1A Safety Trial of Inhaled PK10571 (GB002) Phase 1
Not yet recruiting NCT03683953 - The Treatment of Bronchopulmonary Dysplasia by Intratracheal Instillation of Mesenchymal Stem Cells Phase 1
Recruiting NCT05546567 - NOPARK Open Label Extension Study N/A
Recruiting NCT05413226 - Effect of Different Ingestion Doses of Celastrol on Human Sperm Motility N/A
Recruiting NCT05112159 - Study of IPG1094 in Healthy Participants Phase 1
Completed NCT04689035 - A Phase 1 Study in Healthy Volunteers to Evaluate the Safety, Tolerability and Pharmacokinetics of AVLX-144 Phase 1
Completed NCT04335045 - Phase I Study of PH100 (Ecklonia Cava Phlorotannins) Phase 1
Completed NCT05037227 - Safety Profile Following Inactivated COVID-19 Vaccine in Healthy Adults Aged >18 Years in Indonesia
Recruiting NCT05517291 - DCB Versus Primary Selective Stenting in TASC C/D Femoropopliteal Artery Disease N/A
Enrolling by invitation NCT06446778 - Haemodynamic Mechanisms and Multicentre Prospective Cohort Study of the Pipeline Flow-diverting Device for the Treatment of Intracranial Aneurysms. Evaluation of the Safety and Efficacy of the Pipeline Flow-diverting Device for the Treatment of Intracranial Aneurysms
Recruiting NCT04573049 - The Effectiveness and Safety of Levosimendan in Patients With Severe Aortic Stenosis and Heart Failure Undergoing Transcatheter Aortic Valve Replacement Phase 4
Completed NCT05585463 - Safety of Acupuncture and Intracutaneous Needles in Pediatric Cancer Patients: a Retrospective Study (ACUSAFE2021)
Completed NCT04188821 - Reduction of Seroma and Improvement of QoL in Breast Reconstruction With Tissue Expander N/A
Completed NCT03667430 - Safety Evaluation of Porous Silica in Men N/A
Completed NCT04499482 - Safety and Tolerability of Soy Fiber N/A
Completed NCT03141905 - Sick-Day Protocol to Improve Outcomes in Chronic Kidney Disease N/A
Completed NCT05244161 - A Quasi-experimental Evaluation of the Malezi Program in Tanzania N/A
Recruiting NCT03791372 - Clinical Effect and Safety of Autologous Umbilical Cord Blood Transfusion in the Treatment of Cerebral Palsy Phase 1
Not yet recruiting NCT04774900 - Standardization of Ambulance Equipment