Effects of Laryngeal Tube Ventilation on no Flow Time During Out of Hospital Cardiac Arrest (FLOWERS)
2. juli 2012 oppdatert av: University Hospital, Grenoble
Reduction of no Flow Time During Out of Hospital Cardiac Arrest by Using Laryngeal Tube for Airway Management by Nurses.
International recommendations stress on the importance of no flow time reduction in cardiac arrest management. In fact, no flow time is an independent factor of morbidity and mortality.
In France, cardiac arrests are treated by first responders (including emergency nurses) before the arrival of a mobile intensive care unit. Those first responders use bag-valve-mask for ventilation and therefore practice conventional CPR (30 chest compression / 2 ventilation rhythm). Laryngeal tube is a safe and efficient device in cardiac arrest ventilation. The purpose of our study is to compare the no flow time between two strategies of out of hospital cardiac arrest management by first responders: conventional CPR with bag-valve-mask ventilation vs. compression only CPR with Laryngeal Tube ventilation.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Multicentric, prospective, controlled, randomized study with parallel groups in single blind.
Patients will be included in chronological periods to avoid selection biais (one month with the first medical device the next month with the other one). The determination of these periods will be centralized. The emergency vehicles will be supplied sufficiently with devices. This design has been chosen in order to answer to the emergency problem.
Patients will be included and ventilated by paramedical staff (first responders) before medical staff (Mobile Intensive Care Unit) intervention. Complete detailed information will be given to the patient or to the family and consent asked.
The comparison of no flow time between the two strategies in out of hospital cardiac arrest will be the following :
A : ventilation by bag valve mask and interrupted chest compression B : ventilation by laryngeal tube and continuous chest compression
Studietype
Intervensjonell
Registrering (Faktiske)
84
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Isere
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Fontaine, Isere, Frankrike, 38602
- SDIS
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Grenoble, Isere, Frankrike, 38043
- Samu Smur
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- preliminary treatment of cardiac arrest by fire fighters (Basic Life support)
- more than 18 years
- patient affiliated to the social security system or equivalent
Exclusion Criteria:
- certain death
- patient deprived of freedom by judicial or administrative decision
- patient under legal protection
- Pregnancy, parturient or breast feeding
- facial trauma
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: ventilation by laryngeal tube
ventilation by laryngeal tube and continuous chest compression
|
Comparison of no flow time between two strategies in out of hospital cardiac arrest
Andre navn:
|
|
Sham-komparator: ventilation by bag valve mask
ventilation by bag valve mask and interrupted chest compression
|
Comparison of no flow time between two strategies in out of hospital cardiac arrest
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
comparison of no flow time between two strategies
Tidsramme: arrival of paramedical staff T0
|
group A : ventilation by bag valve mask and interrupted chest compression group B : ventilation by laryngeal tube and continuous chest compression outcome measure : time of no flow during Resuscitation by trained paramedical staff in out of hospital cardiac arrest |
arrival of paramedical staff T0
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Tidsramme: during cardiac arrest at T0
|
No flow proportion during resuscitation by paramedical staff after emergency training
|
during cardiac arrest at T0
|
|
qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Tidsramme: during cardiac arrest at T0
|
no flow proportion on total resuscitation duration
|
during cardiac arrest at T0
|
|
qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Tidsramme: during cardiac arrest at T0
|
number of failure installation after 2 tests
|
during cardiac arrest at T0
|
|
qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Tidsramme: during cardiac arrest at T0
|
Time of device installation
|
during cardiac arrest at T0
|
|
qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Tidsramme: during cardiac arrest at T0
|
chest expansion during insuflation (yes/no)
|
during cardiac arrest at T0
|
|
qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Tidsramme: during cardiac arrest at T0
|
Mortality : spontaneous cardiac activity recovery, hospital admission, reanimation service or hospital exit date, survival at 28 days , CPC evaluation for patients alive
|
during cardiac arrest at T0
|
|
qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Tidsramme: during cardiac arrest at T0
|
incident during ventilation : obstruction number of manipulations to optimize ventilation |
during cardiac arrest at T0
|
|
qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Tidsramme: during cardiac arrest at T0
|
ETCO2
|
during cardiac arrest at T0
|
|
qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Tidsramme: during cardiac arrest at T0
|
Number of external electric shocks
|
during cardiac arrest at T0
|
|
qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Tidsramme: during cardiac arrest a T0
|
degradation due to technical manipulations
|
during cardiac arrest a T0
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Vincent Danel, MD, University Hospital, Grenoble
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
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Studierekorddatoer
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Studer hoveddatoer
Studiestart
1. mars 2011
Primær fullføring (Faktiske)
1. februar 2012
Studiet fullført (Faktiske)
1. juni 2012
Datoer for studieregistrering
Først innsendt
11. februar 2011
Først innsendt som oppfylte QC-kriteriene
11. februar 2011
Først lagt ut (Anslag)
14. februar 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
3. juli 2012
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. juli 2012
Sist bekreftet
1. juli 2012
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- DCIC - 1014
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