Effects of Laryngeal Tube Ventilation on no Flow Time During Out of Hospital Cardiac Arrest (FLOWERS)
2. Juli 2012 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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
Studientyp
Interventionell
Einschreibung (Tatsächlich)
84
Phase
- Phase 3
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Isere
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Fontaine, Isere, Frankreich, 38602
- SDIS
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Grenoble, Isere, Frankreich, 38043
- Samu Smur
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Aktiver 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
Andere Namen:
|
|
Schein-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
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
comparison of no flow time between two strategies
Zeitfenster: arrival of paramedical staff T0
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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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Zeitfenster: during cardiac arrest at T0
|
No flow proportion during resuscitation by paramedical staff after emergency training
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during cardiac arrest at T0
|
|
qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Zeitfenster: 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
Zeitfenster: during cardiac arrest at T0
|
number of failure installation after 2 tests
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during cardiac arrest at T0
|
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qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Zeitfenster: during cardiac arrest at T0
|
Time of device installation
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during cardiac arrest at T0
|
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qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Zeitfenster: during cardiac arrest at T0
|
chest expansion during insuflation (yes/no)
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during cardiac arrest at T0
|
|
qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Zeitfenster: 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
|
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qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Zeitfenster: during cardiac arrest at T0
|
incident during ventilation : obstruction number of manipulations to optimize ventilation |
during cardiac arrest at T0
|
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qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Zeitfenster: during cardiac arrest at T0
|
ETCO2
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during cardiac arrest at T0
|
|
qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Zeitfenster: during cardiac arrest at T0
|
Number of external electric shocks
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during cardiac arrest at T0
|
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qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Zeitfenster: during cardiac arrest a T0
|
degradation due to technical manipulations
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during cardiac arrest a T0
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Vincent Danel, MD, University Hospital, Grenoble
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
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Nützliche Links
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. März 2011
Primärer Abschluss (Tatsächlich)
1. Februar 2012
Studienabschluss (Tatsächlich)
1. Juni 2012
Studienanmeldedaten
Zuerst eingereicht
11. Februar 2011
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
11. Februar 2011
Zuerst gepostet (Schätzen)
14. Februar 2011
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
3. Juli 2012
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
2. Juli 2012
Zuletzt verifiziert
1. Juli 2012
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- DCIC - 1014
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