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Effect of Push-Dose Adrenaline on Peri-intubation Hypotension During Rapid Sequence Intubation in the Emergency Department

2026年6月7日 更新者:Emre Kudu、Marmara University Pendik Training and Research Hospital

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

状態

まだ募集していません

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

介入

入学 (推定)

128

段階

  • フェーズ 4

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。

研究連絡先

研究連絡先のバックアップ

研究場所

    • Pendik
      • Istanbul、Pendik、トルコ(Türkiye)、34899
        • Marmara University Pendik Training and Research Hospital
        • コンタクト:
        • コンタクト:
        • 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

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

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

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

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: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:
  • プラセボ
  • 生理食塩水
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:
  • エピネフリン

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

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

  • スタディチェア:Emre Kudu, MD、Marmara University

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 (推定)

2026年6月1日

一次修了 (推定)

2026年12月1日

研究の完了 (推定)

2026年12月1日

試験登録日

最初に提出

2026年5月26日

QC基準を満たした最初の提出物

2026年5月27日

最初の投稿 (実際)

2026年6月2日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月10日

QC基準を満たした最後の更新が送信されました

2026年6月7日

最終確認日

2026年6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。

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