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CompletedNCT02908659FR-REAUpdated Feb 1, 2018

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

An observational study in Non Ventilated ICU Patients, sponsored by Centre Hospitalier Departemental Vendee. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-01.

Sponsored by Centre Hospitalier Departemental Vendee · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
122
Ages
18 Years and older
Sex
All
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Study 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.

02

Conditions studied

  • Non Ventilated ICU Patients

Keywords

  • intensive care unit
  • patient's monitoring
  • respiratory rate
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In context

Lead sponsor

Centre Hospitalier Departemental Vendee is the lead sponsor of 81 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients admitted to ICU unit at La Roche sur yon Hospital

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
122 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: through study completion, within 6 months

Secondary outcomes

  1. Ratio of artifact alarms among all alarms generated by the monitoring device

    Artifact alarm : monitoring is functional but the measure is false

    Time frame: through study completion within 6 months

  2. Ratio of technical alarms among all alarms generated by the monitoring device

    Technical alarm : Alarm leading to a reactivation of the monitoring system.

    Time frame: through study completion within 6 months

  3. Ratio of significant alarms among all alarms generated by the monitoring device

    Significant alarm: True alarm triggered by a correct measure

    Time frame: through study completion within 6 months

  4. Number of care activity interrupted by a respiratory rate alarm generated by the monitoring device

    Time frame: through study completion within 6 months

  5. Setting of alarms on the monitoring device

    Time frame: through study completion within 6 months

  6. ICU length of stay

    Time frame: Until discharge from ICU, an expected average of 7 days

  7. all-cause ICU mortality

    Time frame: Until discharge from ICU, an expected average of 7 days ]

  8. Ratio of respiratory rate alarms generated by the monitoring device among all ICU alarms

    Time frame: through study completion within 6 months

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Study locations

1 site
  • CHD Vendee
    La roche sur yon, 85000, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02908659
Lead sponsor
Centre Hospitalier Departemental Vendee
Responsible party
Sponsor
First posted
Sep 21, 2016
Start date
Sep 21, 2016
Primary completion
Feb 28, 2017
Completion
Feb 28, 2017
Last update
Feb 1, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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