Pre-Hospital Advanced Airway Management in the Nordic Countries (PHAST)
Pre-Hospital Advanced Airway Management in the Nordic Countries - A Prospective Multicentre Observational Study
調査の概要
詳細な説明
Pre-Hospital Advanced Airway Management (PHAAM) is a potentially lifesaving intervention. A recent meta-analysis of >15.000 patients reported a variation in the prehospital endotracheal intubation (PHETI) success rate with different methods used and provider background. A recent prehospital study from London revealed a significantly higher intubation failure rate among non-anaesthesiologist physicians. In Scandinavia different types of emergency medical services (EMS) and professionals provide PHAAM. The success rate of PHETI, incidence of difficult intubation and complications in the Nordic countries is not known. Although the EMS structure in Scandinavia is reasonably similar, there are some inter- and intra-national differences regarding mission profile, staffing, systems for dispatch and on-scene management. A Danish PHAAM study demonstrated a 99,7% anaesthesiologist PHETI success rate with a 7,9% complication rate. The authors concluded the study was from a homogenous Danish system limiting the ability to generalise the findings to other systems with different staffing, caseload or case mix.
The PHAST investigators aim to provide prospective multicentre data on the pre-hospital intubation success rate and complications in the Nordic countries. Additionally the investigators will compare the PHAAM procedure for different subgroups of patients, regions and EMS organisations.
In the PHAST observational study twelve Nordic (Sweden, Norway, Denmark and Finland) Helicopter and Rapid Response Emergency Medical Services will include patients during 18 months. The decision to perform PHAAM is based on the discretion of prehospital provider. The PHAAM core data will be prospectively collected according the template by Sollid et al.
The primary endpoint is PHETI success on ≤2 attempts and no complications. Secondary endpoints include overall PHETI success rate, PHETI success on 1st, 2nd, 3rd and >3rd attempt, difficult PHETI, success rate of laryngeal mask and surgical airway, PHAAM complications and prehospital mortality.
Through predefined analysis of the data, the PHAST investigators hope to
- Describe the characteristics and outcome of advanced prehospital airway management.
- Identify which groups of critically injured or ill patients will benefit most from competent advanced prehospital airway management, and identify specific areas for future research.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
VästraGötaland
-
Gothenburg、VästraGötaland、スウェーデン
- HEMS VGR
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
All patients requiring prehospital advanced airway management (PHAAM) by the Helicopter Emergency Medical Services (EMS) and Ground EMS (GEMS) units in the study. PHAAM includes endotracheal intubation, supraglottic airway and percutaneous/surgical airway. The indications for performing PHAAM as categorised by Sollid et al. are
- Decreased level of consciousness
- Hypoxemia
- Ineffective ventilation
- Existing airway obstruction
- Impending airway obstruction
- Combative or uncooperative patient
- Relief of pain or distress
- Cardiopulmonary arrest
- Other
Exclusion Criteria:
- Patients receiving advanced airway management during so-called secondary missions (or inter-hospital transfer)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：コホート
- 時間の展望：見込みのある
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 |
|---|---|---|
|
PHETI ≤ 2attempts and no complications
時間枠：At hospital admission (</= 1 day)
|
Prehospital Endotracheal Intubation success and complications as defined by Sollid et al (Sollid SJ, Lockey D, Lossius HM: A consensus-based template for uniform reporting of data from pre-hospital advanced airway management.
Scand J Trauma Resusc Emerg Med 2009, 17:58.)
|
At hospital admission (</= 1 day)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
PHETI overall success rate
時間枠：At hospital admission (</= 1 day)
|
PHETI= Prehospital Endotracheal Intubation as defined by Sollid et al (Sollid SJ, Lockey D, Lossius HM: A consensus-based template for uniform reporting of data from pre-hospital advanced airway management.
Scand J Trauma Resusc Emerg Med 2009, 17:58.)
|
At hospital admission (</= 1 day)
|
|
PHETI success on 1st attempt and no complications
時間枠：At hospital admission (</= 1 day)
|
Endpoint as defined by Sollid et al (Sollid SJ, Lockey D, Lossius HM: A consensus-based template for uniform reporting of data from pre-hospital advanced airway management.
Scand J Trauma Resusc Emerg Med 2009, 17:58.)
|
At hospital admission (</= 1 day)
|
|
PHETI success rate on 1st, 2nd, 3rd and >3rd attempt
時間枠：At hospital admission (</= 1 day)
|
PHETI success as defined by Sollid et al (Sollid SJ, Lockey D, Lossius HM: A consensus-based template for uniform reporting of data from pre-hospital advanced airway management.
Scand J Trauma Resusc Emerg Med 2009, 17:58.)
|
At hospital admission (</= 1 day)
|
|
PHAAM Complications
時間枠：At hospital admission (</= 1 day)
|
PHAAM Complications as defined by Sollid et al (Sollid SJ, Lockey D, Lossius HM: A consensus-based template for uniform reporting of data from pre-hospital advanced airway management.
Scand J Trauma Resusc Emerg Med 2009, 17:58.)
|
At hospital admission (</= 1 day)
|
|
Success rate of airway back-up devices
時間枠：At hospital admission (</= 1 day)
|
Endpoint as defined by Sollid et al (Sollid SJ, Lockey D, Lossius HM: A consensus-based template for uniform reporting of data from pre-hospital advanced airway management.
Scand J Trauma Resusc Emerg Med 2009, 17:58.)
|
At hospital admission (</= 1 day)
|
|
Pre-hospital mortality
時間枠：At hospital admission (</= 1 day)
|
Endpoint as defined by Sollid et al (Sollid SJ, Lockey D, Lossius HM: A consensus-based template for uniform reporting of data from pre-hospital advanced airway management.
Scand J Trauma Resusc Emerg Med 2009, 17:58.)
|
At hospital admission (</= 1 day)
|
|
Other pre-specified endpoints and analysis as defined by the ERB-submitted protocol
時間枠：At hospital admission (</= 1 day)
|
Endpoints as defined by Sollid et al (Sollid SJ, Lockey D, Lossius HM: A consensus-based template for uniform reporting of data from pre-hospital advanced airway management.
Scand J Trauma Resusc Emerg Med 2009, 17:58.)
|
At hospital admission (</= 1 day)
|
|
Mortality
時間枠：At hospital discharge (estimated average 7 days)
|
At hospital discharge (estimated average 7 days)
|
|
|
死亡
時間枠：30日で
|
30日で
|
|
|
PHETI ≤ 2attempts and no complications among patients with TBI
時間枠：At hospital discharge (estimated average 7 days)
|
PHETI ≤ 2attempts and no complications among subgroup of patients with Traumatic Brain Injury.
Prehospital Advanced Airway Management (PHAAM) success and complications as defined by Sollid et al (Sollid SJ, Lockey D, Lossius HM: A consensus-based template for uniform reporting of data from pre-hospital advanced airway management.
Scand J Trauma Resusc Emerg Med 2009, 17:58.)
|
At hospital discharge (estimated average 7 days)
|
協力者と研究者
スポンサー
捜査官
- スタディチェア：Hans Morten Lossius, MD, PhD、Norwegian Air Ambulance Foundation
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- PHAST-01
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