A Study of Silent Alarm Delivery Versus Standard Audible Alarm Delivery in Intensive Care and High Dependency Units (DECIBEL)

MindWave Medical Inc

Status: Active, not recruiting

Conditions: Nursing Workload; Delirium in the Intensive Care Unit; Alarms; Alarm Fatigue; Alarm Fatigue in Intensive Care Unit Nurses; Burnout, Healthcare Workers; Noise in the ICU

Treatments: Other: Silent alarm strategy

Study type: Interventional

Funder types: Industry

Identifiers

NCT07364097

D26

Details and patient eligibility

About

The goal of the trial is to learn if a strategy to eliminate audible alarm noise in intensive care and high dependency units can reduce overall noise levels, patient delirium, staff alarm fatigue, and staff burnout. Researchers will implement a silent alarm strategy in specific care units for four weeks and compare this to a separate 4 weeks where a silent strategy is not implemented. Noise, burnout, delirium levels, and staff alarm response times will be compared between the silent and non-silent units.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Admission to Intensive or high dependency care unit.

Exclusion criteria

• Pre-existing diagnosis of dementia
• Endotracheally intubated (may enroll when extubated)
• CNS injury, infection, or malignancy as reason for admission.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Silent alarm strategy

Experimental group

Description:

The intervention consists of the implementation of a silent alarm system for the clinical environment. The silent alarm system consists of a self-locating interface device, which is interposed between an alarm-generating device and its audio output. This device contains communication, locating, motion, logic, and relay chips, which enable the interface device to identify its location and staff responsible for that location, as well as to detect audio output from the alarm-generating device, and to control the audible state of that output. The Interface device can communicate with separate bone conduction headsets worn by staff, which contain sensors that confirm staff presence at the headset, and buttons for response to an alarm announcement. The interface device then delivers alarms silently to those staff specifically responsible for its location when a responsible staff member can be identified, confirmed to be present, and accepts responsibility for the alarm through button action

Treatment:

Other: Silent alarm strategy

Control

No Intervention group

Description:

In the control arm of the study, interface devices (as described in the experimental arm) will remain in place for data collection only, but will allow all alarms to be audible, and will not attempt silent alarms.