橈骨動脈カニューレ挿入は肝移植手術における手の灌流指数(PI)に影響しますか? (radial artery)
橈骨動脈カニューレ挿入は肝移植における手の灌流指数に影響しますか?
This randomized controlled trial compared palpation-guided and ultrasound-guided radial artery catheterization in adult liver transplant recipients. The primary outcome was the change in perfusion index (Pi) from baseline after catheterization. Secondary outcomes included first-attempt success, number of skin punctures, procedure time, overall success with the assigned technique, and local complications.
調査の概要
状態
詳細な説明
## DLiver transplantation is associated with major hemodynamic changes, and continuous invasive arterial pressure monitoring is an essential part of perioperative management. The radial artery is the most commonly used site. Repeated punctures and mechanical trauma during catheterization may cause local complications and affect peripheral perfusion. Ultrasound guidance may facilitate catheter placement with fewer punctures.
The perfusion index (Pi), derived from pulse oximetry, is the ratio of the pulsatile to the non-pulsatile optical signal and is used to monitor peripheral perfusion. Because Pi is also influenced by systemic hemodynamics, sympathetic activity, temperature, nociception and drugs, changes in Pi were not interpreted as direct evidence of radial artery vasospasm.
In this prospective, randomized, controlled, two-arm parallel-group trial, adult liver transplant recipients were randomized 1:1 to palpation-guided or ultrasound-guided radial artery catheterization. Randomization used a computer-generated sequence and sequentially numbered, opaque, sealed envelopes prepared by an independent person. The envelope was opened after induction of general anesthesia, once hemodynamic stability was achieved and immediately before catheterization. All procedures were performed by a single anesthesiologist experienced in both techniques, using the same 20-gauge non-guidewire arterial cannula in both groups, preferably on the non-dominant hand after a normal modified Allen test.
In the ultrasound group, a high-frequency linear probe was used with a short-axis out-of-plane approach and dynamic needle tip positioning. Pi was measured continuously with a pulse oximetry sensor placed on the index finger the hand. Pi, heart rate, SpO2, pleth variability index (PVI), SpHb and SpOC were recorded immediately before catheterization (baseline) and immediately after catheterization; Pi was additionally recorded 5 and 10 minutes after catheterization.
The primary outcome was the change in Pi from baseline over time. The primary analysis used a linear mixed-effects model including group, time and the group-by-time interaction to account for repeated measurements. Secondary outcomes were compared with appropriate tests (t test or Mann-Whitney U test; chi-square or Fisher's exact test). Results were reported with effect estimates and 95% confidence intervals; a two-sided p<0.05 was considered statistically significant.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:duygu demiroz
- 電話番号:905319504421
- メール:drduygudemiroz@hotmail.com
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
説明
Inclusion Criteria:
- Adult patients (18 years of age or older) undergoing liver transplantation.
- Patients eligible for radial artery catheterization as part of perioperative monitoring.
- Patients who provide informed consent to participate in the study.
Exclusion Criteria:
- Patients in whom radial artery catheterization is contraindicated.
- Patients who do not provide informed consent to participate in the study.
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: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 |
|---|---|
|
他の:Conventional Palpation
Conventional Palpation |
Radial artery catheterization was performed after induction of general anesthesia, preferably on the non-dominant hand after a normal modified Allen test. The radial pulse was identified by palpation and the artery was cannulated using anatomical landmarks with a 20-gauge non-guidewire arterial cannula, the same cannula used in the ultrasound group. The procedure was limited to a maximum of three skin punctures. |
|
他の:Guided Catheterization
-Radial artery catheterization was performed after induction of general anesthesia using the conventional palpation technique. The radial pulse was identified by palpation and the artery was cannulated using anatomical landmarks with a 20-gauge non-guidewire arterial cannula, limited to a maximum of three skin punctures. |
Radial artery catheterization performed under real-time ultrasound guidance using an integrated guidewire arterial cannula system. |
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 |
|---|---|---|
|
Change in Perfusion Index from Baseline Following Radial Artery Catheterization
時間枠:Perfusion index (Pi) will be measured at baseline, immediately after radial artery catheterization, and at 5 and 10 minutes after the procedure to evaluate changes in peripheral perfusion.
|
Perfusion index (Pi) will be measured at baseline, immediately after radial artery catheterization, and at 5 and 10 minutes after the procedure to assess changes in peripheral perfusion between the palpation-guided and ultrasound-guided catheterization groups. |
Perfusion index (Pi) will be measured at baseline, immediately after radial artery catheterization, and at 5 and 10 minutes after the procedure to evaluate changes in peripheral perfusion.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
First-Attempt Radial Artery Catheterization Success Rate
時間枠:During the catheterization procedure
|
The proportion of participants in whom radial artery catheterization is successfully completed on the first skin puncture. |
During the catheterization procedure
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:duygu demiröz、INONU UNİVERSİTY
出版物と役立つリンク
一般刊行物
- Brzezinski M, Luisetti T, London MJ. Radial artery cannulation: a comprehensive review of recent anatomic and physiologic investigations. Anesth Analg. 2009 Dec;109(6):1763-81. doi: 10.1213/ANE.0b013e3181bbd416.
- Numaguchi A, Adachi YU, Aoki Y, Ishii Y, Suzuki K, Obata Y, Sato S, Nishiwaki K, Matsuda N. Radial artery cannulation decreases the distal arterial blood flow measured by power Doppler ultrasound. J Clin Monit Comput. 2015 Oct;29(5):653-7. doi: 10.1007/s10877-014-9648-5. Epub 2014 Dec 16.
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
その他の研究ID番号
- INU-LT-RAC-2026-01
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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