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

Completed

• Conditions: Non Ventilated ICU Patients

• Registration Number: NCT02908659
• Lead Sponsor: Centre Hospitalier Departemental Vendee

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-07
• Study First Submitted QC: 2016-09-16
• Study Start: 2016-09-21
• Study First Posted: 2016-09-21
• Primary Completion: 2017-02-28
• Study Completion: 2017-02-28
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-31
• Last Update Posted: 2018-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Setting of alarms on the monitoring device	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
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.
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
ICU length of stay	Until discharge from ICU, an expected average of 7 days
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

Trial Locations

Locations (1)

CHD Vendee; 🇫🇷 La roche sur yon, France