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FEMART-1 Pilot Study (FEMART-1)

2026年5月18日 更新者：Emergency Medical Service, Prague

The FEMART-1 Pilot Study is focused on evaluating the feasibility, safety, and procedural timing of prehospital femoral arterial sheath placement in patients with non-traumatic out-of-hospital cardiac arrest (OHCA), both during ongoing cardiopulmonary resuscitation and after return of spontaneous circulation (ROSC).

The primary objective of the study is to enable invasive arterial blood pressure monitoring for targeted and continuous hemodynamic management using vasopressor therapy in the prehospital setting. The study evaluates the feasibility, safety, and procedural performance of invasive arterial monitoring with the aim of improving assessment of the patient's hemodynamic status and enabling more accurate titration of vasopressor support. This approach may reduce episodes of hypotension and decrease the risk of recurrent cardiac arrest while allowing safer transport to specialized cardiac arrest centers.

Femoral arterial access enables more precise monitoring of perfusion pressure, targeted vasopressor titration, and early recognition of impending circulatory collapse. The intervention may contribute to improved early organ perfusion and could be associated with more favorable neurological and overall clinical outcomes after cardiac arrest. In accordance with the ERC Guidelines 2025, which emphasize active hemodynamic optimization after ROSC and acknowledge the potential role of invasive arterial pressure monitoring during ongoing resuscitation, the study evaluates not only feasibility, safety, and procedural timing, but also the potential clinical benefit of continuous hemodynamic-guided management in the prehospital phase, including (1) early identification of hypotension, (2) targeted vasopressor administration, and (3) prevention of re-arrest.

The study is conducted by the Prague Air Rescue Service Kryštof 01 (Prague Emergency Medical Services) in collaboration with the Central Bohemian Emergency Medical Service, the Second Department of Internal Medicine - Cardiology and Angiology of the General University Hospital in Prague and First Faculty of Medicine, Charles University, and the Department of Anesthesiology, Resuscitation and Intensive Care Medicine of the General University Hospital in Prague and First Faculty of Medicine, Charles University.

FEMART-1 is designed as a prospective pilot study without external funding.

調査の概要

状態

募集

条件

介入・治療

研究の種類

介入

入学 (推定)

60

段階

  • 適用できない

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

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:

* Non-traumatic out-of-hospital cardiac arrest (OHCA).

Patients meeting criteria for one of the following clinical scenarios:

Group A - ECPR-like group:

  • Refractory cardiac arrest, including cardiac arrest occurring in the presence of the EMS crew.
  • Age 18-70 years.
  • Effective bystander cardiopulmonary resuscitation.
  • Initial rhythm of ventricular fibrillation (VF), pulseless ventricular tachycardia (pVT), or pulseless electrical activity (PEA).

Group B - post-ROSC group:

  • Return of spontaneous circulation (ROSC) after non-traumatic OHCA.
  • Age 18-70 years.

Exclusion Criteria:

  • Trauma as the probable primary cause of cardiac arrest.

  • Known severe comorbidity, including:

    • terminal stage of incurable disease (advanced malignancy, advanced dementia, terminal pulmonary disease, terminal heart failure, or palliative care status),
    • established do-not-resuscitate (DNR) status,
    • severe pre-existing neurological disability (CPC 3 or CPC 4),
    • known severe peripheral arterial disease or known occlusion of lower limb arteries,
    • suspected pulmonary embolism with indication for thrombolytic therapy,
    • known severe hematological disease associated with severe thrombocytopenia,
    • morbid obesity.
  • Known or suspected pregnancy.

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：処理
  • 割り当て：非ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ：Prehospital Femoral Arterial Sheath Insertion
Patients receive standard advanced prehospital resuscitation and post-resuscitation care including ultrasound-guided femoral arterial sheath insertion for invasive blood pressure monitoring and potential facilitation of subsequent VA-ECMO cannulation if clinically indicated.
手順：Prehospital Ultrasound-Guided Femoral Arterial Sheath Placement
Ultrasound-guided placement of a femoral arterial sheath in the prehospital setting during ongoing cardiopulmonary resuscitation or after return of spontaneous circulation. The procedure is performed to enable invasive arterial blood pressure monitoring, optimization of hemodynamic management during ongoing cardiopulmonary resuscitation or post-resuscitation care, prevention of re-arrest, and to facilitate rapid transition to potential VA-ECMO cannulation if clinically indicated.
他の名前：
  • Femoral Arterial Cannulation
  • Prehospital Arterial Access
  • Femoral Arterial Sheath Insertion
  • Ultrasound-Guided Femoral Access
介入なし：Standard Prehospital Care
Patients receive standard advanced prehospital resuscitation and post-resuscitation care without prehospital femoral arterial sheath insertion.

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
Percentage of Patients With Successful and Functional Invasive Arterial Blood Pressure Monitoring
時間枠：During prehospital care until hospital arrival
Feasibility of prehospital femoral arterial sheath placement expressed as the percentage of patients with successfully established and functional invasive arterial blood pressure monitoring among patients in whom prehospital femoral arterial sheath placement was attempted following a clinical decision to perform the procedure.
During prehospital care until hospital arrival
Percentage of Patients With Major Procedure-Related Complications
時間枠：From sheath insertion until hospital admission
Safety of prehospital femoral arterial sheath placement expressed as the percentage of patients with major procedure-related complications among patients in whom prehospital femoral arterial sheath placement was attempted following a clinical decision to perform the procedure. Major complications include clinically significant bleeding, vascular injury, distal limb ischemia, or sheath-related complications requiring therapeutic intervention.
From sheath insertion until hospital admission
Procedural Time Characteristics of Prehospital Femoral Arterial Sheath Placement
時間枠：During prehospital care until hospital arrival
Assessment of procedural time characteristics of prehospital femoral arterial sheath placement among patients in whom the procedure was attempted following a clinical decision to perform the intervention. Time intervals are assessed using predefined procedural time points recorded during the intervention.
During prehospital care until hospital arrival

二次結果の測定

結果測定
メジャーの説明
時間枠
Use of Vasopressor or Inotropic Therapy in the Prehospital Setting
時間枠：During prehospital care until hospital arrival
Comparison of the number and proportion of patients receiving vasopressor or inotropic therapy during prehospital care.
During prehospital care until hospital arrival
Recognition of Impending Hemodynamic Collapse After ROSC
時間枠：During prehospital care until hospital arrival
Comparison of the number and proportion of patients with return of spontaneous circulation who develop hypotension (MAP below 50 mmHg) associated with re-initiation of cardiopulmonary resuscitation, initiation of vasopressor therapy, or escalation of ongoing vasopressor therapy during prehospital care.
During prehospital care until hospital arrival
Prehospital Re-arrest Rate
時間枠：During prehospital care until hospital arrival
Comparison of the number and proportion of patients requiring defibrillation or manual/mechanical cardiopulmonary resuscitation after previously achieved return of spontaneous circulation during prehospital care.
During prehospital care until hospital arrival
In-Hospital Re-arrest Within 20 Minutes After Handover
時間枠：Within 20 minutes after hospital admission
Comparison of the number and proportion of patients transferred to the receiving hospital with return of spontaneous circulation who subsequently require defibrillation or manual/mechanical cardiopulmonary resuscitation within 20 minutes after hospital handover.
Within 20 minutes after hospital admission
Adequate Mean Arterial Pressure at Hospital Handover
時間枠：At hospital admission
Comparison of the number and proportion of patients with mean arterial pressure above 60 mmHg at hospital handover.
At hospital admission
Blood Lactate Level at Hospital Admission
時間枠：At hospital admission
Comparison of median and mean lactate levels measured at hospital admission.
At hospital admission
Heart Rate at Hospital Admission
時間枠：At hospital admission
Comparison of median and mean heart rate measured at hospital admission.
At hospital admission
Survival and Neurological Clinical Outcomes
時間枠：Through hospital discharge (up to 30 days) and at 30 days after the index event
Comparison of the number and percentage of patients surviving to hospital discharge, surviving with favorable neurological outcome defined as Cerebral Performance Category (CPC) 1-2 at hospital discharge, and surviving 30 days after the index event.
Through hospital discharge (up to 30 days) and at 30 days after the index event

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。

スポンサー

Emergency Medical Service, Prague

協力者

General University Hospital, Prague
Emergency Medical Service of the Central Bohemian Region, Czech Republic

捜査官

  • 主任研究者：Jan Spicak, MD、Prague Emergency Medical Services

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

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5月11日

一次修了 (推定)

2026年12月31日

研究の完了 (推定)

2027年3月30日

試験登録日

最初に提出

2026年5月7日

QC基準を満たした最初の提出物

2026年5月12日

最初の投稿 (実際)

2026年5月19日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月20日

QC基準を満たした最後の更新が送信されました

2026年5月18日

最終確認日

2026年5月1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

  • ZZSHMP_001_2026

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?

未定

IPD プランの説明

Individual participant data sharing has not yet been determined. Future data sharing decisions will depend on data protection requirements, institutional policies, ethical considerations, and the feasibility of adequate anonymization of prehospital and hospital clinical data.

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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