Manual vs Pneumatic Compression to Prevent Radial Artery Occlusion After Transradial Procedures (RADIAL-HEMO)
Manual Radial Compression Versus Gradual Pneumatic Compression for the Prevention of Radial Artery Occlusion After Transradial Cardiac Catheterization: A Pragmatic Multicenter Study
This study evaluates two commonly used methods of achieving hemostasis after transradial cardiac catheterization: manual compression and pneumatic compression with gradual deflation.
Transradial access is widely used for diagnostic and interventional cardiac procedures due to its safety profile, but radial artery occlusion remains a relevant complication that may limit future vascular access.
In this pragmatic, prospective, multicenter study conducted in routine clinical practice, adult patients undergoing transradial cardiac catheterization were assigned to receive either manual compression or pneumatic compression using a standardized patent hemostasis protocol. The primary objective is to compare the incidence of radial artery occlusion at 30 days between both strategies.
Secondary outcomes include local vascular complications, patient-reported pain, and total compression time.
調査の概要
詳細な説明
Transradial access has become the preferred approach for diagnostic and interventional coronary procedures due to its association with reduced bleeding complications, earlier mobilization, and shorter hospital stay compared with transfemoral access. However, radial artery occlusion (RAO) remains a relevant access-site complication that may limit future vascular access or the use of the radial artery as a conduit for coronary artery bypass grafting.
Hemostasis following radial sheath removal is a critical step in preserving arterial patency. Two commonly used strategies include manual compression using sterile gauze and non-circumferential adhesive dressing, and pneumatic compression using dedicated mechanical devices typically applied with gradual deflation protocols. Both approaches aim to achieve effective hemostasis while maintaining antegrade arterial flow, a concept known as patent hemostasis.
This study was designed as a pragmatic, prospective, multicenter interventional study conducted across eight hospitals in Spain, with central coordination from Hospital Clinic of Barcelona. The objective was to compare the effectiveness and safety of manual radial compression versus pneumatic compression with gradual deflation under standardized patent hemostasis protocols in real-world clinical practice.
Consecutive adult patients undergoing diagnostic or interventional cardiac catheterization via transradial access were included. After sheath removal, participants were assigned in a 1:1 predefined alternating sequence to either manual compression or pneumatic compression strategies.
In the manual compression group, hemostasis was achieved using direct pressure with sterile gauze and a non-circumferential adhesive dressing, with progressive adjustment of pressure to maintain arterial patency assessed by plethysmography. In the pneumatic compression group, a dedicated compression device was applied and gradually deflated according to a standardized protocol to achieve patent hemostasis.
The primary outcome was radial artery occlusion at 30 days, defined as absence of distal plethysmographic signal during radial artery compression assessed using the Barbeau test. Secondary outcomes included local vascular complications (such as hematoma, persistent bleeding, or pseudoaneurysm), patient-reported pain assessed using a visual analog scale (VAS), and total compression time.
All participating centers followed a unified protocol, and hemostasis procedures were performed by trained nursing staff. The study was designed to reflect routine clinical practice conditions and to evaluate whether clinical outcomes are primarily influenced by the type of compression strategy or by the standardized implementation of patent hemostasis protocols.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Barcelona、スペイン、08036
- Hospital Clinic of Barcelona
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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:
- Adults aged ≥18 years
- Undergoing diagnostic or interventional cardiac catheterization via transradial access
- Preserved dual hand circulation confirmed by Barbeau test
- Ability to provide informed consent
- Ability to complete 30-day follow-up
Exclusion Criteria:
- Refusal to participate
- Inability to complete follow-up
- Abnormal collateral circulation (Barbeau type D)
- Initial failure of radial access
- Contraindication to prolonged radial compression
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: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 |
|---|---|
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実験的:Manual Compression
Hemostasis achieved by direct manual compression using sterile gauze and a non-circumferential adhesive dressing, with progressive adjustment of pressure to maintain arterial patency.
Compression duration was approximately 3-4 hours depending on the procedure.
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Direct manual compression using sterile gauze and a non-circumferential adhesive dressing applied after radial sheath removal, with progressive pressure adjustment to achieve patent hemostasis.
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実験的:Pneumatic Compression
Hemostasis achieved using a pneumatic compression device with gradual deflation following a standardized patent hemostasis protocol, ensuring bleeding control while maintaining arterial flow.
The device was progressively deflated until complete removal.
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Application of a pneumatic compression device with gradual deflation following a standardized patent hemostasis protocol to maintain arterial flow while achieving hemostasis.
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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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Radial Artery Occlusion
時間枠:30 days
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Radial artery occlusion assessed by absence of distal plethysmographic signal during radial artery compression using the Barbeau test.
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30 days
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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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Local Vascular Complications
時間枠:During hospital stay and up to 30 days
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Incidence of access-site complications including hematoma, persistent bleeding, pseudoaneurysm, or other local vascular complications.
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During hospital stay and up to 30 days
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Pain During Compression
時間枠:Immediately after compression
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Patient-reported pain during the compression period assessed using a visual analog scale (VAS).
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Immediately after compression
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Total Compression Time
時間枠:During procedure
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Total duration of radial compression measured in minutes from sheath removal to device or dressing removal.
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During procedure
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協力者と研究者
捜査官
- 主任研究者:Montserrat Pardo, RN、Hospital Clinic of Barcelona
研究記録日
主要日程の研究
研究開始 (実際)
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 (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
その他の研究ID番号
- HCB-RAO-HEMOSTASIS-2022
- HCB/2021/1166 (その他の識別子:Clinical Research Ethics Committee of Hospital Clínic of Barcelona)
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
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