Evaluation of Proximal Massage and Palm-to-Fist Tapping on Reducing the Risk of Phlebitis
Evaluation of the Effect of Proximal Massage and Palm-to-Fist Tapping on Reducing the Risk of Phlebitis Associated With Peripheral Venous Catheter Insertion
調査の概要
状態
詳細な説明
Peripheral venous catheter insertion is a common clinical procedure performed in a substantial proportion of hospitalized patients. It is estimated that between 58.7% and 86.7% of hospitalized patients require a peripheral venous catheter during their hospital stay, and, ideally, catheter dwell time should not exceed six days. Indications for peripheral venous catheterization are diverse and include hemodynamic monitoring, intravenous administration of fluids and medications, blood transfusions, and the administration of contrast media for diagnostic imaging procedures.
Despite being a routine and relatively simple procedure, complications associated with peripheral venous catheter use continue to represent an important public health concern because they are associated with prolonged hospital stays, delayed patient discharge, and increased healthcare costs. The most common complications include phlebitis, infiltration, ecchymosis, extravasation, and embolism. These complications may occur while the catheter remains in place or even up to 96 hours after catheter removal. Therefore, given the widespread use of peripheral venous catheters and the potentially deleterious consequences of these complications, appropriate catheter management and care are essential to reduce their incidence.
Phlebitis is defined as inflammation of the venous intima and is clinically characterized by local inflammatory signs, including erythema, edema, and pain. Reported incidence rates range from 2% to 80%, depending largely on the control of modifiable risk factors. Three major categories of risk factors have been associated with the development of phlebitis. The first comprises patient-related factors, including age, sex, and pre-existing medical conditions. The second includes chemical factors, primarily related to the dose and osmolarity of intravenously administered medications. The third encompasses mechanical factors, such as catheter size, insertion site, and catheter material.
Several types of phlebitis have been described, each associated with different risk factors. Mechanical phlebitis is related to catheter size and material, inadequate catheter stabilization that facilitates catheter movement and subsequent irritation of the vascular wall, and catheter placement near a joint. Bacterial phlebitis develops as a consequence of poor aseptic technique or prolonged catheter dwell time. Finally, chemical phlebitis is associated with the characteristics of the cannulated vein and the type of infused solution, particularly highly acidic or alkaline solutions.
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：Sandra Valderrama, Dra
- 電話番号：6932 +57(601) 594616
- メール：svalderrama.med@javeriana.edu.co
研究場所
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Bogota D.C.
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Bogotá、Bogota D.C.、コロンビア
- 募集
- Hospital Universitario San Ignacio
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コンタクト：
- Sandra Valderrama, Dra.
- 電話番号：6932 +57 (601) 5946161
- メール：slvalderrama@husi.org.co
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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:
a. Eligible participants will be adults aged 18 years or older who have had a PIVC inserted into an upper extremity within the previous 24 hours and are expected to require peripheral intravenous access for at least 48 hours.
Exclusion Criteria:
a.Patients will be excluded if they have impaired consciousness, critical illness precluding participation in the intervention, physical limitations preventing performance of the prescribed exercises, anatomical or functional abnormalities of the catheterized upper extremity, or if adequate clinical follow-up cannot be ensured.
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：順次割り当て
- 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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プラセボコンパレーター：Estandard peripheral venous catheter care protocol
Participants assigned to the control group will receive the standard peripheral venous catheter care protocol implemented at Hospital Universitario San Ignacio
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control group will receive the standard peripheral venous catheter care protocol implemented
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実験的：Effect of proximal massage and palm-to-fist tapping
The intervention will consist of two non-pharmacological components.
Following hand hygiene, participants will receive gentle massage using the palmar surface of the fingers over an area located approximately 2-3 cm proximal to the peripheral intravenous catheter insertion site.
Each session will last approximately 2-3 minutes and will be performed three times daily for up to four consecutive days or until catheter removal, whichever occurs first.
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Following hand hygiene, participants will receive gentle massage using the palmar surface of the fingers over an area located approximately 2-3 cm proximal to the peripheral intravenous catheter insertion site.
Each session will last approximately 2-3 minutes and will be performed three times daily for up to four consecutive days or until catheter removal, whichever occurs first
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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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Incidence of phlebitis during the observation period
時間枠：Participants will be followed for 4 days (96 hours) after catheter insertion. Outcome assessments will be performed at 24, 48, 72, and 96 hours.
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To evaluate the effect of proximal massage and palm-to-fist tapping exercises on reducing the risk of peripheral venous catheter-related phlebitis during the first 96 hours after catheter insertion
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Participants will be followed for 4 days (96 hours) after catheter insertion. Outcome assessments will be performed at 24, 48, 72, and 96 hours.
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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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Time to first episode of phlebitis, maximum phlebitis severity during follow-up and evaluate factors associated with the development of phlebitis
時間枠：Participants will be followed for 4 days (96 hours) after catheter insertion. Outcome assessments will be performed at 24, 48, 72, and 96 hours.
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Participants assigned to the intervention group will receive standardized instruction from the study investigators and will be encouraged
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Participants will be followed for 4 days (96 hours) after catheter insertion. Outcome assessments will be performed at 24, 48, 72, and 96 hours.
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協力者と研究者
捜査官
- 主任研究者：Ángel García, Dr、Hospital Universitario San Ignacio
出版物と役立つリンク
一般刊行物
- Heng SY, Yap RT, Tie J, McGrouther DA. Peripheral Vein Thrombophlebitis in the Upper Extremity: A Systematic Review of a Frequent and Important Problem. Am J Med. 2020 Apr;133(4):473-484.e3. doi: 10.1016/j.amjmed.2019.08.054. Epub 2019 Oct 10.
- Cihan Erdoğ an B, Zehra GB. Nursing initiatives in peripheral intravenous catheter re- lated flebit and preventıon. Gazi J Heal Sci 2020;5:30-36
- Ozturk D, Erdogan BC, Dogan N, Kiziltepe K, Baykara ZG. Phlebitis related to peripheric intravenous catheter: A point prevalence study. J Ankara Univ Fac Med 2021;74:310-316
- Lv L, Zhang J. The incidence and risk of infusion phlebitis with peripheral intravenous catheters: A meta-analysis. J Vasc Access. 2020 May;21(3):342-349. doi: 10.1177/1129729819877323. Epub 2019 Sep 23.
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 (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
その他の研究ID番号
- 2024/293
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?
IPD プランの説明
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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