Non Ventilated ICU Patients Clinical Trial
— FR-REAOfficial title:
Relevance and Possible Nuisances of Respiratory Rate Alarm Generated by Multi-parametric Monitors in Non Ventilated ICU Patients.A Prospective, Monocentric, Observational Study
| Verified date | January 2018 |
| Source | Centre Hospitalier Departemental Vendee |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 122 |
| Est. completion date | February 28, 2017 |
| Est. primary completion date | February 28, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | CHD Vendee | La roche sur yon |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Departemental Vendee |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Number of care activity interrupted by a respiratory rate alarm generated by the monitoring device | through study completion within 6 months | ||
| Secondary | Setting of alarms on the monitoring device | through study completion within 6 months | ||
| Secondary | ICU length of stay | Until discharge from ICU, an expected average of 7 days | ||
| Secondary | all-cause ICU mortality | Until discharge from ICU, an expected average of 7 days ] | ||
| Secondary | Ratio of respiratory rate alarms generated by the monitoring device among all ICU alarms | through study completion within 6 months |