Effect of Push-Dose Adrenaline on Peri-intubation Hypotension During Rapid Sequence Intubation in the Emergency Department
Effect of Push-Dose Adrenaline on Peri-intubation Cardiovascular and Clinical Outcomes During Rapid Sequence Intubation in the Emergency Department: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial
Rapid sequence intubation is commonly performed in the emergency department to secure the airway of critically ill patients. However, blood pressure may decrease during or shortly after intubation because of the patient's underlying illness, the effects of induction medications, and the transition to positive-pressure ventilation. This complication is known as peri-intubation hypotension and is associated with worse clinical outcomes.
This study will evaluate whether a preemptive low dose of intravenous adrenaline, also known as epinephrine, can reduce peri-intubation hypotension in adult emergency department patients undergoing rapid sequence intubation. Participants will be randomly assigned to receive either 10 mcg of intravenous adrenaline or 1 mL of 0.9% sodium chloride placebo immediately before induction. The study will compare hemodynamic changes, vasopressor requirements, safety outcomes, and mortality between the two groups.
調査の概要
詳細な説明
Rapid sequence intubation is a standard advanced airway procedure used in emergency departments for critically ill patients who require rapid and secure airway control. Although this procedure is clinically necessary, it may be associated with peri-intubation hypotension, commonly defined as systolic blood pressure below 90 mmHg or mean arterial pressure below 65 mmHg during or after the intubation period. This hemodynamic deterioration may result from the patient's underlying critical illness, the cardiovascular effects of induction agents, reduced venous return after initiation of positive-pressure ventilation, or a combination of these factors.
Preventing hypotension during rapid sequence intubation is an important component of peri-intubation resuscitation. Intravenous fluids and vasopressor infusions are frequently used when hypotension develops, but these interventions may not always be fast enough to prevent early hemodynamic collapse. Push-dose vasopressors are used in emergency and critical care practice to provide short-term hemodynamic support. However, prospective randomized evidence regarding the preemptive use of push-dose adrenaline during emergency department rapid sequence intubation remains limited.
This is a single-center, prospective, randomized, double-blind, placebo-controlled trial conducted in the emergency department of Marmara University Pendik Training and Research Hospital. Adult patients undergoing rapid sequence intubation, who are hypotensive or considered to be at significant risk of hypotension, will be enrolled after informed consent is obtained from the patient or legally authorized representative when applicable.
Participants will be randomized in a parallel-group design to receive either 10 mcg intravenous adrenaline or 1 mL of 0.9% sodium chloride placebo immediately before the administration of induction agents. The intervention and placebo syringes will be identical in volume and appearance. Syringes will be prepared according to the randomization list by an independent non-blinded nurse who will not participate in clinical care, outcome assessment, or data collection. Treating physicians, participants, investigators, care providers, and outcome assessors will remain blinded to group allocation.
The decision to perform intubation, selection and dosing of induction and neuromuscular blocking agents, endotracheal tube size, and post-intubation management will be determined by the treating physician according to standard emergency department practice and current clinical guidance. Study procedures will not delay airway management or standard resuscitative care.
Hemodynamic variables, including systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate, will be recorded at baseline and during the first 60 minutes after intubation. The study will evaluate peri-intubation hypotension, changes in mean arterial pressure, post-intubation vasopressor requirements, new ventricular or supraventricular arrhythmias, reactive hypertension, cardiac arrest, and mortality at predefined time points. The planned enrollment is 128 participants.
研究の種類
入学 (推定)
段階
- フェーズ 4
連絡先と場所
研究連絡先
- 名前:Emre Kudu, MD
- 電話番号:+90 5067613610
- メール:dr.emre.kudu@gmail.com
研究連絡先のバックアップ
- 名前:Emir Ünal, MD
- メール:emirunal@gmail.com
研究場所
-
-
Pendik
-
Istanbul、Pendik、トルコ(Türkiye)、34899
- Marmara University Pendik Training and Research Hospital
-
コンタクト:
- Emre Kudu, MD
- 電話番号:+90 5067613610
- メール:dr.emre.kudu@gmail.com
-
コンタクト:
- Emir Ünal, MD
- メール:emirunal@gmail.com
-
主任研究者:
- Emre Kudu, MD
-
副調査官:
- Emir Ünal, MD
-
副調査官:
- Hasan Temel, MD
-
副調査官:
- Erhan Altunbaş, MD
-
副調査官:
- Sinan Karacabey, MD
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Adult patients aged 18 years or older
- Patients in the emergency department for whom the treating physician has made a clinical decision to perform rapid sequence intubation
- Patients who are hypotensive, defined as systolic blood pressure less than 90 mmHg or mean arterial pressure less than 65 mmHg, or who are considered to be at significant risk of hypotension during rapid sequence intubation
- Written informed consent obtained from the patient or from a legally authorized representative when the patient lacks decision-making capacity
Exclusion Criteria:
- Pregnancy
- Known allergy to adrenaline
- Known contraindication to adrenaline administration
- Withdrawal of consent by the patient or legally authorized representative after enrollment
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
- 主な目的:防止
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター:Placebo
Adult emergency department patients undergoing rapid sequence intubation who receive standard care and a 1 mL intravenous placebo bolus of 0.9% sodium chloride immediately before induction.
|
Participants receive 1 mL of 0.9% sodium chloride intravenously as placebo immediately before the administration of induction agents for rapid sequence intubation.
The placebo syringe is identical in volume and appearance to the adrenaline syringe.
他の名前:
|
|
アクティブコンパレータ:Push dose adrenaline
Adult emergency department patients undergoing rapid sequence intubation who receive standard care and a preemptive 10 mcg intravenous bolus dose of adrenaline immediately before induction.
|
Participants receive 10 mcg of intravenous adrenaline, administered as 1 mL of a 10 mcg/mL dilution, immediately before the administration of induction agents for rapid sequence intubation.
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 |
|---|---|---|
|
Peri-intubation hypotension
時間枠:Within 60 minutes after intubation
|
Peri-intubation hypotension will be defined as the occurrence of systolic blood pressure less than 90 mmHg or mean arterial pressure less than 65 mmHg at any time during the first 60 minutes after intubation.
The incidence of peri-intubation hypotension will be compared between the adrenaline and placebo groups.
|
Within 60 minutes after intubation
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in mean arterial pressure from baseline
時間枠:Baseline, 1, 5, 10, 15, 30, 45, and 60 minutes after intubation
|
Mean arterial pressure will be recorded at baseline and at 1, 5, 10, 15, 30, 45, and 60 minutes after intubation.
Changes from baseline will be compared between the adrenaline and placebo groups.
|
Baseline, 1, 5, 10, 15, 30, 45, and 60 minutes after intubation
|
|
Change in heart rate from baseline
時間枠:Baseline, 1, 5, 10, 15, 30, 45, and 60 minutes after intubation
|
Heart rate will be recorded at baseline and at 1, 5, 10, 15, 30, 45, and 60 minutes after intubation.
Changes from baseline will be compared between the adrenaline and placebo groups.
|
Baseline, 1, 5, 10, 15, 30, 45, and 60 minutes after intubation
|
|
Post-intubation vasopressor requirement
時間枠:1 hour and 24 hours after intubation
|
The need for continuous vasopressor infusion after intubation will be recorded.
Total vasopressor dose administered during the first hour and the first 24 hours after intubation will be compared between the adrenaline and placebo groups.
|
1 hour and 24 hours after intubation
|
|
Adverse events
時間枠:Within 24 hours after intubation
|
Adverse events including reactive hypertension, cardiac arrest, mortality
|
Within 24 hours after intubation
|
協力者と研究者
捜査官
- スタディチェア:Emre Kudu, MD、Marmara University
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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
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
- 09.2026.764
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。