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

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ClinicalTrials.gov Identifier: NCT02908659
Recruitment Status : Completed
First Posted : September 21, 2016
Last Update Posted : February 1, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Departemental Vendee

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.


Condition or disease
Non Ventilated ICU Patients

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Study Type : Observational
Actual Enrollment : 122 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : September 21, 2016
Actual Primary Completion Date : February 28, 2017
Actual Study Completion Date : February 28, 2017



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients admitted to ICU unit at La Roche sur yon Hospital
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02908659


Locations
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France
CHD Vendee
La roche sur yon, France, 85000
Sponsors and Collaborators
Centre Hospitalier Departemental Vendee

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Responsible Party: Centre Hospitalier Departemental Vendee
ClinicalTrials.gov Identifier: NCT02908659     History of Changes
Other Study ID Numbers: CHD 087-16
First Posted: September 21, 2016    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Centre Hospitalier Departemental Vendee:
intensive care unit
patient's monitoring
respiratory rate