Preoxygenation With High-flow Nasal Oxygen in Adult Trauma Patients During Rapid Sequence Induction Anaesthesia (PRIOR-Trauma)
Preoxygenation With High-flow Nasal Oxygen in Comparison to Standard Face Mask in Adult Trauma Patients During Rapid Sequence Induction Anesthesia- a Prospective, Non-randomized, Before-and-after Study
Previous studies investigating apnoea oxygenation has shown that delivering oxygen via a high flow can maintain adequate oxygen saturation levels in a patient for over 30 minutes.
It has recently been demonstrated, in several studies, that High Flow Nasal Oxygen (HFNO) used during preoxygenation in patients undergoing emergency surgery is at least equally effective as preoxygenation with standard tight fitting mask. Data from these recent studies investigating arterial oxygen saturation levels during rapid sequence induction anaesthesia have not been able to detect any difference between the two methods. The mean apnea time among the patients in the previous studies have been relatively short.
Patients suffering traumatic injuries could be more prone to desaturate during prolonged apnea due to being hemodynamic unstable or suffering injuries to the respiratory tract.
Based on the above, the aim is now to conduct a trial where trauma patients are preoxygenated with high flow nasal oxygen before anaesthetised with rapid sequence induction (RSI) technique. The trial is set to be a before-and-after study. During approximately 6 to 9 months data will be registered from trauma patients undergoing emergency anaesthesia where preoxygenation is performed according to standard rutin, with traditional facemask. During the coming six to nine months trauma patients undergoing emergency anaesthesia will be preoxygenated with high flow nasal oxygen. Data will be registered and compared to the data collected from the patients preoxygenated with facemark.
The general purpose of this project is to compare the preoxygenation technique based on HFNO with traditional preoxygenation with a tight fitting mask, with the main focus being oxygen saturation levels, during rapid sequence induction (RSI) intubation in trauma patients in need of immediate anaesthesia.
調査の概要
状態
条件
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前：Malin Jonsson Fagerlund
- 電話番号：0707691405
- メール：malin.jonsson-fagerlund@sll.se
研究場所
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Stockholm、スウェーデン、SE-17176
- 募集
- Karolinska University Hospital Solna
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コンタクト：
- Malin Jonsson Fagerlund
- 電話番号：+46707691405
- メール：malin.jonsson.fagerlund@ki.se
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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:
- 1 Adult, ≥18 years old
- 2 Level 1 trauma with patients in need of emergency anaesthesia before leaving the trauma unit (trauma room or nearby operating theatre).
Exclusion Criteria:
- 1 Patients with or with risk of skull or facial injuries where application of nasal cannula is decided to be avoided by the trauma team.
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 |
介入・治療 |
|---|---|
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Tight fitting facemask
Preoxygenation with tight facemask, 100% oxygen.
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Preoxygenation with tight facemask, 10 L/min, 100% oxygen.
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High flow nasal oxygen
Preoxygenation with high flow nasal oxygen, 100% oxygen
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Preoxygenation with high flow nasal oxygen, 40-70 L/min, 100% oxygen.
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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 |
|---|---|---|
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Number of patients with a peripheral oxygen saturation (SpO2) below 93%
時間枠：From start of anaesthesia until 1 minute after tracheal intubation.
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Compare the number of patients with a peripheral oxygen saturation (SpO2) below 93% from induction of anesthesia (when induction drug is administered) until one minute after intubation between the group preoxygenated using HFNO and the group preoxygenated with traditional tight-fitting mask.
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From start of anaesthesia until 1 minute after tracheal intubation.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Lowest median SpO2.
時間枠：From start of anaesthesia until 1 minute after tracheal intubation.
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Lowest median SpO2 during preoxygenation using HFNO compared to traditional preoxygenation from when first anesthetic drug is administered until 1 minute after intubation
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From start of anaesthesia until 1 minute after tracheal intubation.
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End tidal gas levels
時間枠：At the first breath after tracheal intubation.
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Difference in levels of ETO2 and ETCO2 in the first breath after intubation with HFNO oxygenation compared to traditional pre-oxygenation.
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At the first breath after tracheal intubation.
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Time span from start of preoxygenation until intubation.
時間枠：Could vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.
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Compare the time span from start of preoxygenation until intubation between the HFNO group and the group with traditional preoxygenation.
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Could vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.
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Time span from entering trauma room until intubation.
時間枠：Could vary depending on patient and trauma, from a couple of minutes up to an hour.
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Time span from when the patient enters the trauma room until intubation in the HFNO group compared to the group with traditional preoxygenation.
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Could vary depending on patient and trauma, from a couple of minutes up to an hour.
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Difficulties with induction of anaesthesia
時間枠：Could vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.
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Compare the perceived difficulties during induction of anaesthesia between the HFNO technique and traditional preoxygenation, for example tolerance to mask or nasal cannula
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Could vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.
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Frequency of complications
時間枠：Could vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.
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Frequency of complications (aspiration, signs of intraabdominal/intracranial gas, difficulties intubating the trachea, hypotension) in the HFNO group compared to the group preoxygenated with traditional facemask.
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Could vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.
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協力者と研究者
捜査官
- 主任研究者：Malin Jonsson Fagerlund、Karolinska University Hospital and Karolinska Institute
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
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 (実際)
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
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