Clinical trial NCT02908659: Relevance and Nuisances of Respiratory Rate Alarm Generated by Multi-parametric Monitors in Non Ventilated ICU Patients
Official title: Relevance and Possible Nuisances of Respiratory Rate Alarm Generated by Multi-parametric Monitors in Non Ventilated ICU Patients.A Prospective, Monocentric, Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Ventilated ICU Patients
Keywords: intensive care unit
patient's monitoring
respiratory rate
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
First posted: 2016-09-21
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to ICU unit at La Roche sur yon Hospital

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of useful alarms within 2000 patient-monitored hours
timeFrame: through study completion, within 6 months
Secondary outcomes:
measure: Ratio of artifact alarms among all alarms generated by the monitoring device
timeFrame: through study completion within 6 months
measure: Ratio of technical alarms among all alarms generated by the monitoring device
timeFrame: through study completion within 6 months
measure: Ratio of significant alarms among all alarms generated by the monitoring device
timeFrame: through study completion within 6 months
measure: Number of care activity interrupted by a respiratory rate alarm generated by the monitoring device
timeFrame: through study completion within 6 months
measure: Setting of alarms on the monitoring device
timeFrame: through study completion within 6 months
measure: ICU length of stay
timeFrame: Until discharge from ICU, an expected average of 7 days
measure: all-cause ICU mortality
timeFrame: Until discharge from ICU, an expected average of 7 days ]
measure: Ratio of respiratory rate alarms generated by the monitoring device among all ICU alarms
timeFrame: through study completion within 6 months
Other outcomes:
Locations:
city: La roche sur yon
country: France
facility: CHD Vendee
Study officials:
References: