Effects of Laryngeal Tube Ventilation on no Flow Time During Out of Hospital Cardiac Arrest (FLOWERS)
2 lipca 2012 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Szczegółowy opis
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
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
84
Faza
- Faza 3
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Isere
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Fontaine, Isere, Francja, 38602
- SDIS
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Grenoble, Isere, Francja, 38043
- Samu Smur
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Badania usług zdrowotnych
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Aktywny komparator: ventilation by laryngeal tube
ventilation by laryngeal tube and continuous chest compression
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Comparison of no flow time between two strategies in out of hospital cardiac arrest
Inne nazwy:
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Pozorny komparator: ventilation by bag valve mask
ventilation by bag valve mask and interrupted chest compression
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Comparison of no flow time between two strategies in out of hospital cardiac arrest
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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comparison of no flow time between two strategies
Ramy czasowe: 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
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Ramy czasowe: during cardiac arrest at T0
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No flow proportion during resuscitation by paramedical staff after emergency training
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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
Ramy czasowe: during cardiac arrest at T0
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no flow proportion on total resuscitation duration
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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
Ramy czasowe: during cardiac arrest at T0
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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
Ramy czasowe: during cardiac arrest at T0
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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
Ramy czasowe: during cardiac arrest at T0
|
chest expansion during insuflation (yes/no)
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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
Ramy czasowe: during cardiac arrest at T0
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Mortality : spontaneous cardiac activity recovery, hospital admission, reanimation service or hospital exit date, survival at 28 days , CPC evaluation for patients alive
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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
Ramy czasowe: during cardiac arrest at T0
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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
Ramy czasowe: during cardiac arrest at T0
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ETCO2
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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
Ramy czasowe: 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
Ramy czasowe: during cardiac arrest a T0
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degradation due to technical manipulations
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during cardiac arrest a T0
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Główny śledczy: Vincent Danel, MD, University Hospital, Grenoble
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
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Przydatne linki
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 marca 2011
Zakończenie podstawowe (Rzeczywisty)
1 lutego 2012
Ukończenie studiów (Rzeczywisty)
1 czerwca 2012
Daty rejestracji na studia
Pierwszy przesłany
11 lutego 2011
Pierwszy przesłany, który spełnia kryteria kontroli jakości
11 lutego 2011
Pierwszy wysłany (Oszacować)
14 lutego 2011
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
3 lipca 2012
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
2 lipca 2012
Ostatnia weryfikacja
1 lipca 2012
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- DCIC - 1014
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