Pre-hospital Hypoxemia in Trauma Patients
Prevalence of Pre-hospital Hypoxemia in Trauma Patients: Do Trauma Patients Need Oxygen?
調査の概要
状態
条件
詳細な説明
Trauma patients in the United States frequently receive high-flow high-concentration supplemental oxygen in the pre-hospital setting, yet their physiologic need is rarely known. Providing oxygen to everyone regardless of need may seem straightforward, but the practice has extensive implications in logistically challenging areas such as a combat arena or mass casualty event, and is not supported by care guidelines. Indeed, too much oxygen can be harmful for some patients.1, 2 If it is the case, that not all trauma patients require oxygen, this would decrease the logistical burden of providing oxygen in the pre-hospital environment. No study has yet been performed that describes the proportion of patients requiring oxygen, the amount of oxygen they require, and whether or not oxygen is beneficial to outcomes. This prospective observational cohort investigation aims to bridge the knowledge gap surrounding the need and possible benefits or harms arising from oxygen therapy. In our Emergency Medical Services (EMS) systems, the written standard of care is to provide oxygen only to maintain oxygen saturation at 95% or when hemorrhagic shock or traumatic brain injury are suspected.3 We will observe patterns of oxygen treatment and outcome for patients treated according to this written standard of care, and compare this to the treatment and outcomes for patients transported by EMS units who continue their usual practice pattern.
Specifically, we aim to:
- Identify the proportion of trauma patients who are hypoxemic or who have traumatic brain injury or hemorrhagic shock at the time of initial EMS contact
- Identify the proportion of trauma patients who develop hypoxemia or hemorrhagic shock while in the pre-hospital setting
- Identify differences in clinically important outcomes associated with treatments driven by written standard of care compared with the usual practice pattern of EMS units. These outcomes include requirement for advanced airway management, hospital and intensive care unit lengths of stay, and disposition (including in-hospital and 30-day mortality)
- Determine the amount of oxygen (Liters per minute) required to reverse hypoxemia
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
Ohio
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Cincinnati、Ohio、アメリカ、45267
- University Hospital
-
-
参加基準
適格基準
就学可能な年齢
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:
- acute traumatic injury
- transported directly to study hospital
- meets at least one trauma consult/trauma stat criteria
Exclusion Criteria:
- lack of continuous peripheral pulse oximetry data
- age <18 years
- on prescribed home oxygen therapy prior to trauma
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
コホートと介入
グループ/コホート |
---|
Written standard of care
|
Usual practice pattern
|
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 |
時間枠 |
---|---|
Proportion of trauma patients who are hypoxemic or who have traumatic brain injury or hemorrhagic shock at the time of initial emergency medical services (EMS) contact
時間枠:At enrollment
|
At enrollment
|
二次結果の測定
結果測定 |
時間枠 |
---|---|
Proportion of trauma patients who develop hypoxemia or hemorrhagic shock while in the pre-hospital setting
時間枠:at enrollment
|
at enrollment
|
Amount of oxygen required to correct hypoxemia
時間枠:at enrollment
|
at enrollment
|
Clinically important outcomes associated with treatments driven by written standard of care compared with the usual practice pattern of EMS units
時間枠:at study conclusion
|
at study conclusion
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Jason T McMullan, MD、University of Cincinnati
研究記録日
主要日程の研究
研究開始
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 (見積もり)
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
その他の研究ID番号
- FA8650-05-2-6518-661150
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。