Effects of Laryngeal Tube Ventilation on no Flow Time During Out of Hospital Cardiac Arrest (FLOWERS)
2012年7月2日 更新者：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.
調査の概要
詳細な説明
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
研究の種類
介入
入学 (実際)
84
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Isere
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Fontaine、Isere、フランス、38602
- SDIS
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Grenoble、Isere、フランス、38043
- Samu Smur
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：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
他の名前：
|
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偽コンパレータ：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
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
comparison of no flow time between two strategies
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
時間枠：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
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qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
時間枠：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
時間枠：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
時間枠：during cardiac arrest at T0
|
Time of device installation
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during cardiac arrest at T0
|
|
qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
時間枠：during cardiac arrest at T0
|
chest expansion during insuflation (yes/no)
|
during cardiac arrest at T0
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qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
時間枠：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
時間枠：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
時間枠：during cardiac arrest at T0
|
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
時間枠：during cardiac arrest at T0
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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
時間枠：during cardiac arrest a T0
|
degradation due to technical manipulations
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during cardiac arrest a T0
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Vincent Danel, MD、University Hospital, Grenoble
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2011年3月1日
一次修了 (実際)
2012年2月1日
研究の完了 (実際)
2012年6月1日
試験登録日
最初に提出
2011年2月11日
QC基準を満たした最初の提出物
2011年2月11日
最初の投稿 (見積もり)
2011年2月14日
学習記録の更新
投稿された最後の更新 (見積もり)
2012年7月3日
QC基準を満たした最後の更新が送信されました
2012年7月2日
最終確認日
2012年7月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。