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Completed

NCT Number: NCT02908659

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

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.

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Key information

Conditions

Non Ventilated ICU Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHD Vendee

La Roche-sur-Yon, 85000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of useful alarms within 2000 patient-monitored hours

    Time frame: 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 outcomes

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

    Time frame: through study completion within 6 months

    Artifact alarm : monitoring is functional but the measure is false

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

    Time frame: through study completion within 6 months

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

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

    Time frame: through study completion within 6 months

    Significant alarm: True alarm triggered by a correct measure

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Departemental Vendee

Other

Registry information

Official study title

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

Acronym: FR-REA

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 21, 2016
Registry last updated
Feb 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.