Relevance and Nuisances of Respiratory Rate Alarm Generated by Multi-parametric Monitors in Non Ventilated ICU Patients

Relevance and Possible Nuisances of Respiratory Rate Alarm Generated by Multi-parametric Monitors in Non Ventilated ICU Patients.A Prospective, Monocentric, Observational Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02908659

Acronym

FR-REA

Enrollment

122

Registered

2016-09-21

Start date

2016-09-21

Completion date

2017-02-28

Last updated

2018-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Ventilated ICU Patients

Keywords

intensive care unit, patient's monitoring, respiratory rate

Brief summary

In ICU setting, a large number of medical devices are attached to patients, generating numerous alarm signals. Several studies have demonstrated that most of these alarms are not clinically relevant and tend to lower the attentiveness of healthcare professional and, in turn, lower patient safety.The aim of the study is to assess the relevance of respiratory rate alarm on a monitoring device in non-ventilated ICU patients. The investigator primary hypothesis is that this alarm is potentially useless. If this hypothesis is confirmed, a second interventional trial will be conducted on the impact of this alarm removal.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age over 18 years * Patient hospitalized in ICU * Need for monitoring

Exclusion criteria

* Invasive mechanical ventilation * Non-invasive mechanical ventilation * Patient not monitored * Patient already included in this study * Patient hospitalized without consent and/or deprived of liberty by court's decision * Patient under guardianship or curators * Lack of social insurance * Patient's or next of kin's refusal

Design outcomes

Primary

Measure	Time frame	Description
Number of useful alarms within 2000 patient-monitored hours	through study completion, within 6 months	Number of intervention of healthcare team following a relevant respiratory rate alarm generated by a monitoring device and without any other associated alarm.

Secondary

Measure	Time frame	Description
all-cause ICU mortality	Until discharge from ICU, an expected average of 7 days ]	—
Ratio of respiratory rate alarms generated by the monitoring device among all ICU alarms	through study completion within 6 months	—
Ratio of artifact alarms among all alarms generated by the monitoring device	through study completion within 6 months	Artifact alarm : monitoring is functional but the measure is false
ICU length of stay	Until discharge from ICU, an expected average of 7 days	—
Ratio of significant alarms among all alarms generated by the monitoring device	through study completion within 6 months	Significant alarm: True alarm triggered by a correct measure
Number of care activity interrupted by a respiratory rate alarm generated by the monitoring device	through study completion within 6 months	—
Setting of alarms on the monitoring device	through study completion within 6 months	—
Ratio of technical alarms among all alarms generated by the monitoring device	through study completion within 6 months	Technical alarm : Alarm leading to a reactivation of the monitoring system.

Countries

France

Outcome results