NCT06175091

Brief Summary

Resuscitation patients are monitored for various physiological parameters. When these parameters exceed abnormal thresholds, an audible alarm is triggered. Given the complexity of physiological situations and the number of monitored parameters, the number of alarms within an intensive care unit is significant. In the literature, the number ranges from 100 to 350 alarms per patient per day. Among these alarms, 74 to 99% are deemed irrelevant as they provide false or insignificant information. This study will enable to assess the efficacy of a restrictive protocol for managing alarms as a means of rationalizing their use.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
514

participants targeted

Target at P75+ for not_applicable

Timeline
21mo left

Started Feb 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress56%
Feb 2024Feb 2028

First Submitted

Initial submission to the registry

November 20, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 18, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

February 8, 2024

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2028

Expected
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2028

Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

4 years

First QC Date

November 20, 2023

Last Update Submit

March 9, 2026

Conditions

Intensive Care Unit

Keywords

alarm fatiguenursing staffResuscitation patientsrestrictive alarm strategy

Outcome Measures

Primary Outcomes (2)

  • efficiency criterion: the number of alarms per patient per day

    An efficiency criterion: the number of alarms per patient per day

    1 month

  • A safety criterion: the length of time patients have potentially dangerous heart rate, blood pressure or oxygen saturation values

    A safety criterion: the length of time patients have potentially dangerous heart rate, blood pressure or oxygen saturation values.

    1 month

Secondary Outcomes (4)

  • Incidence of serious adverse events

    1 month

  • Alarm response time

    1 month

  • Evaluation of patient perception using the Discomforts of intensive care patients questionnaire

    1 month

  • Sound level measurement using a sound level meter

    7 days

Study Arms (2)

control group

ACTIVE COMPARATOR

Usual management, i.e. alarm management left to the discretion of the nurse caring for the patient.

Device: alarm management left to the discretion of the nurse

intervention group

EXPERIMENTAL

restrictive alarm strategy

Device: restrictive alarm use strategy

Interventions

restrictive alarm use strategyDEVICE

more restrictive protocol for the use of alarms

intervention group
alarm management left to the discretion of the nurseDEVICE

alarm management left to the discretion of the nurse in charge of the patient

control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient aged ≥ 18 years
  • Patient admitted to the intensive care unit of the ST-ETIENNE University Hospital
  • Patient affiliated or entitled to a social security system
  • Patient having received informed information about the study and having co-signed, with the investigator, a consent to participate in the study or, for patients who are unable to consent due to health condition, a trusted person/family member who has been informed about the study and has who has co-signed, with the investigator, a consent to participate

You may not qualify if:

  • Pregnant and nursing women
  • Persons of legal age under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, 42055, France

RECRUITING

MeSH Terms

Conditions

Alert Fatigue, Health Personnel

Condition Hierarchy (Ancestors)

Mental FatigueFatigueSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Study Officials

  • Guillaume Thiéry, PhD

    Centre Hospitalier Universitaire de Saint Etienne

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guillaume Thiéry, PhD

CONTACT

(04)77127862guillaume.thiery@chu-st-etienne.fr

Amandine BAUDOT, CRA

CONTACT

(0)477829450amandine.baudot@chu-st-etienne.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2023

First Posted

December 18, 2023

Study Start

February 8, 2024

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

February 28, 2028

Last Updated

March 10, 2026

Record last verified: 2026-03

Locations

FR(1)