Non Ventilated ICU PatientsFR-REANCT02908659
Relevance and Nuisances of Respiratory Rate Alarm Generated by Multi-parametric Monitors in Non Ventilated ICU Patients
An observational study of Non Ventilated ICU Patients, run by Centre Hospitalier Departemental Vendee at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Ventilated ICU Patients
- How many people
- 122 participants
- Where
- 1 siteFrance
- Study dates
- 21 Sep 2016to 28 Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to ICU unit at La Roche sur yon Hospital
Who may be able to join
- Age over 18 years
- Patient hospitalized in ICU
- Need for monitoring
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Non Ventilated ICU Patients
- Keywords
- intensive care unit, patient's monitoring, respiratory rate
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, within 6 months
Secondary outcomes (8)
Ratio of artifact alarms among all alarms generated by the monitoring device
Artifact alarm : monitoring is functional but the measure is false
Measured: through study completion within 6 months
Ratio of technical alarms among all alarms generated by the monitoring device
Technical alarm : Alarm leading to a reactivation of the monitoring system.
Measured: through study completion within 6 months
Ratio of significant alarms among all alarms generated by the monitoring device
Significant alarm: True alarm triggered by a correct measure
Measured: through study completion within 6 months
Number of care activity interrupted by a respiratory rate alarm generated by the monitoring device
Measured: through study completion within 6 months
Setting of alarms on the monitoring device
Measured: through study completion within 6 months
ICU length of stay
Measured: Until discharge from ICU, an expected average of 7 days
all-cause ICU mortality
Measured: Until discharge from ICU, an expected average of 7 days ]
Ratio of respiratory rate alarms generated by the monitoring device among all ICU alarms
Measured: through study completion within 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study start21 Sep 2016
- Primary completion28 Feb 2017
- Study completion28 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Ventilated ICU PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02908659
- Sponsor's protocol ID
- CHD 087-16
- Acronym
- FR-REA
- Status last verified
- Jan 2018
- First submitted
- 7 Sep 2016
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02908659
- Acronym / sponsor ID
- FR-REA / CHD 087-16
- Conditions
- Non Ventilated ICU Patients
- Keywords
- intensive care unit, patient's monitoring, respiratory rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Study start
- 21 Sep 2016 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 21 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to ICU unit at La Roche sur yon Hospital
Key inclusion criteria (3 listed)
- Age over 18 years
- Patient hospitalized in ICU
- Need for monitoring
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
8 secondary outcomes
Ratio of artifact alarms among all alarms generated by the monitoring device
Time frame: through study completion within 6 months
Ratio of technical alarms among all alarms generated by the monitoring device
Time frame: through study completion within 6 months
Ratio of significant alarms among all alarms generated by the monitoring device
Time frame: through study completion within 6 months
Number of care activity interrupted by a respiratory rate alarm generated by the monitoring device
Time frame: through study completion within 6 months
Setting of alarms on the monitoring device
Time frame: through study completion within 6 months
ICU length of stay
Time frame: Until discharge from ICU, an expected average of 7 days
all-cause ICU mortality
Time frame: Until discharge from ICU, an expected average of 7 days ]
Ratio of respiratory rate alarms generated by the monitoring device among all ICU alarms
Time frame: through study completion within 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Ventilated ICU Patients, run by Centre Hospitalier Departemental Vendee at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of useful alarms within 2000 patient-monitored hours (time frame: through study completion, within 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2018.