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

31. januar 2018 opdateret af: Centre Hospitalier Departemental Vendee

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.

Studieoversigt

Status

Afsluttet

Betingelser

Non Ventilated ICU Patients

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

122

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Frankrig
- - La roche sur yon, Frankrig, 85000
    - CHD Vendée

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Patients admitted to ICU unit at La Roche sur yon Hospital

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Number of useful alarms within 2000 patient-monitored hours Tidsramme: 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.	through study completion, within 6 months

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Ratio of artifact alarms among all alarms generated by the monitoring device Tidsramme: through study completion within 6 months	Artifact alarm : monitoring is functional but the measure is false	through study completion within 6 months
Ratio of technical alarms among all alarms generated by the monitoring device Tidsramme: through study completion within 6 months	Technical alarm : Alarm leading to a reactivation of the monitoring system.	through study completion within 6 months
Ratio of significant alarms among all alarms generated by the monitoring device Tidsramme: through study completion within 6 months	Significant alarm: True alarm triggered by a correct measure	through study completion within 6 months
Number of care activity interrupted by a respiratory rate alarm generated by the monitoring device Tidsramme: through study completion within 6 months		through study completion within 6 months
Setting of alarms on the monitoring device Tidsramme: through study completion within 6 months		through study completion within 6 months
ICU length of stay Tidsramme: Until discharge from ICU, an expected average of 7 days		Until discharge from ICU, an expected average of 7 days
all-cause ICU mortality Tidsramme: Until discharge from ICU, an expected average of 7 days ]		Until discharge from ICU, an expected average of 7 days ]
Ratio of respiratory rate alarms generated by the monitoring device among all ICU alarms Tidsramme: through study completion within 6 months		through study completion within 6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Centre Hospitalier Departemental Vendee

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

21. september 2016

Primær færdiggørelse (Faktiske)

28. februar 2017

Studieafslutning (Faktiske)

28. februar 2017

Datoer for studieregistrering

Først indsendt

7. september 2016

Først indsendt, der opfyldte QC-kriterier

16. september 2016

Først opslået (Skøn)