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

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

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.

Study Overview

• Status: Completed
• Conditions: Non Ventilated ICU Patients

• Study Type: Observational
• Enrollment (Actual): 122

Contacts and Locations

Study Locations

• France
  • La roche sur yon, France, 85000
    • CHD Vendée

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients admitted to ICU unit at La Roche sur yon Hospital

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ratio of artifact alarms among all alarms generated by the monitoring device	Artifact alarm : monitoring is functional but the measure is false	through study completion within 6 months
Ratio of technical alarms among all alarms generated by the monitoring device	Technical alarm : Alarm leading to a reactivation of the monitoring system.	through study completion within 6 months
Ratio of significant alarms among all alarms generated by the monitoring device	Significant alarm: True alarm triggered by a correct measure	through study completion within 6 months
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
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Departemental Vendee

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2016
• Primary Completion (Actual): February 28, 2017
• Study Completion (Actual): February 28, 2017

Study Registration Dates

• First Submitted: September 7, 2016
• First Submitted That Met QC Criteria: September 16, 2016
• First Posted (Estimate): September 21, 2016

Study Record Updates

• Last Update Posted (Actual): February 1, 2018
• Last Update Submitted That Met QC Criteria: January 31, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: intensive care unit; respiratory rate; patient's monitoring
• Other Study ID Numbers: CHD 087-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO