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Green or Pink? A Comparison of Pain and Procedural Difficulty With Intravenous Cannulas in the Emergency Department

A Comparison of 18-Gauge and 20-Gauge Intravenous Cannulas in Terms of Pain and Procedural Difficulty: A Randomized Controlled Trial in the Emergency Department

Peripheral intravenous catheter (PIVC) insertion is one of the most frequently performed invasive procedures in both medical and nursing practice. It is essential for blood sampling, intravenous (IV) fluid resuscitation, medication administration, blood product transfusion, and IV contrast-enhanced radiological imaging. In emergency department (ED) settings, where patients may deteriorate rapidly, timely and adequate IV access is of critical importance. Larger-bore cannulas allow faster fluid and contrast delivery and are less prone to occlusion; however, Larger-bore cannulas are often perceived to cause greater pain and procedural difficulty compared to smaller-bore cannulas. This perception may lead clinicians to prefer smaller cannulas, potentially compromising care quality in patients who may unexpectedly deteriorate.

Cannula insertion inherently causes discomfort, pain, and anxiety for patients, and multiple failed attempts further amplify these effects. Patient satisfaction, an important dimension of overall care quality, is directly influenced by pain experience and the number of insertion attempts. Patients requiring two or more attempts for successful cannulation are generally classified as having difficult intravenous access (DIVA). Repeated failed attempts are associated with vascular injury, increased patient distress, delays in diagnosis and treatment, and greater consumption of healthcare resources. The A-DIVA score, developed by Van Loon et al., enables risk stratification for IV access difficulty at triage, classifying patients as low, moderate, or high risk, and facilitating proactive measures such as ultrasound guidance or involvement of experienced personnel for high-risk patients.

This single-center, prospective, single-blind, randomized controlled trial aims to compare 18-gauge (18G) and 20-gauge (20G) PIVCs in terms of patient-reported pain intensity and nurse-reported procedural difficulty in adult ED patients with low-to-moderate A-DIVA risk. The investigators hypothesize that 18G cannulas cause similar pain and procedural difficulty compared to 20G cannulas in this patient population.

The study will be conducted at Marmara University Pendik Training and Research Hospital Emergency Department. Ethics approval has been granted by the Marmara University Faculty of Medicine Clinical Research Ethics Committee. Adult patients (18 years and older) requiring IV access for diagnostic or therapeutic purposes and classified as low or moderate A-DIVA risk will be eligible. Patients with cognitive impairment, altered mental status, or hemodynamic instability (systolic BP less than 90 mmHg or mean arterial pressure less than 65 mmHg) will be excluded.

Eligible consenting patients will be randomized 1:1 using a block randomization method (block size of 4) to either 18G or 20G cannula insertion. Cannula assignment will be delivered to nurses in sealed envelopes. Patients will be blinded to cannula size using blackout goggles. Cannulation will be performed by ED nurses following standard antiseptic and securement procedures, targeting the dorsum of the hand, forearm, or antecubital fossa. If the first attempt fails, at least one additional attempt with the assigned cannula will be required before allowing free choice of cannula and site.

The primary outcomes are patient-reported pain intensity and nurse-reported procedural difficulty, each assessed using a 10 cm Visual Analog Scale (VAS) immediately after the first cannulation attempt and compared between the 18G and 20G cannula groups. Secondary outcomes include the comparison of first-attempt cannulation success rate between the 18G and 20G cannula groups. This comparison will also be performed separately according to cannulation site, operator experience, A-DIVA risk category, patient age, and patient sex.

A total of 204 patients (102 per group) will be enrolled, based on 90% power, 5% type I error, a minimum clinically important difference of 13 mm on the VAS, and a 10% dropout allowance.

調査の概要

研究の種類

介入

入学 (実際)

204

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。

研究場所

      • Istanbul、トルコ(Türkiye)
        • Marmara University Pendik Training and Research Hospital

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:

  • 18 years of age or older
  • Requiring intravenous access for diagnostic or therapeutic purposes
  • Classified as low or moderate risk according to the A-DIVA (Adult Difficult Intravenous Access) score
  • Provision of informed consent by the patient, a relative, or a legal guardian

Exclusion Criteria:

  • Inability to effectively communicate pain intensity due to cognitive impairment, altered mental status, or visual or language difficulties
  • Hemodynamic instability defined as systolic blood pressure less than 90 mmHg or mean arterial pressure less than 65 mmHg

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:ランダム化
  • 介入モデル:並列代入
  • マスキング:ダブル

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:18G Cannula Group
Participants in this arm will undergo peripheral intravenous cannulation using an 18-gauge (18G, green) cannula. Cannulation will be performed by emergency department nurses targeting the dorsum of the hand, forearm, or antecubital fossa following standard antiseptic and securement procedures. If the first attempt fails, at least one additional attempt with the assigned 18G cannula will be made before allowing free choice of cannula and site.
Peripheral intravenous cannulation performed using an 18-gauge (18G, green) cannula inserted into the dorsum of the hand, forearm, or antecubital fossa by an emergency department nurse following standard antiseptic and securement procedures. No local anesthetic agents will be used. Patients will be blinded to cannula size using blackout goggles.
アクティブコンパレータ:20G Cannula Group
Participants in this arm will undergo peripheral intravenous cannulation using a 20-gauge (20G, pink) cannula. Cannulation will be performed by emergency department nurses targeting the dorsum of the hand, forearm, or antecubital fossa following standard antiseptic and securement procedures. If the first attempt fails, at least one additional attempt with the assigned 20G cannula will be made before allowing free choice of cannula and site.
Peripheral intravenous cannulation performed using a 20-gauge (20G, pink) cannula inserted into the dorsum of the hand, forearm, or antecubital fossa by an emergency department nurse following standard antiseptic and securement procedures. No local anesthetic agents will be used. Patients will be blinded to cannula size using blackout goggles.

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
Pain intensity
時間枠:Immediately after the first cannulation attempt
Patient-reported pain intensity assessed using a 10 cm Visual Analog Scale (VAS) after the first cannulation attempt, compared between the 18G and 20G cannula groups. The VAS score ranges from 0 (no pain) to 10 (worst imaginable pain). The unit of measure is the score on the Visual Analog Scale (0-10 cm).
Immediately after the first cannulation attempt
Procedural difficulty
時間枠:Immediately after the first cannulation attempt
Nurse-reported procedural difficulty assessed using a 10 cm Visual Analog Scale (VAS) after the first cannulation attempt, compared between the 18G and 20G cannula groups. The VAS score ranges from 0 (no difficulty) to 10 (worst imaginable difficulty). The unit of measure is the score on the Visual Analog Scale (0-10 cm)
Immediately after the first cannulation attempt

二次結果の測定

結果測定
メジャーの説明
時間枠
First-attempt cannulation success rate
時間枠:Immediately after the first cannulation attempt
The proportion of participants with successful cannulation achieved on the first attempt, compared between the 18G and 20G cannula groups. The unit of measure is the percentage of participants (%).
Immediately after the first cannulation attempt
Comparison of first-attempt cannulation success rate by cannulation site between groups
時間枠:Immediately after the first cannulation attempt
The first-attempt cannulation success rate at each cannulation site (dorsum of hand, forearm, or antecubital fossa), assessed by procedural documentation, will be compared between the 18G and 20G cannula groups. The unit of measure is the percentage of participants with successful first-attempt cannulation per site (%).
Immediately after the first cannulation attempt
Comparison of first-attempt cannulation success rate by operator experience between groups
時間枠:Immediately after the first cannulation attempt
The first-attempt cannulation success rate across different levels of operator experience, assessed in years of clinical experience, will be compared between the 18G and 20G cannula groups. The unit of measure is the percentage of participants with successful first-attempt cannulation per operator experience level (%).
Immediately after the first cannulation attempt
Comparison of first-attempt cannulation success rate by A-DIVA score between groups
時間枠:Immediately after the first cannulation attempt
The first-attempt cannulation success rate across A-DIVA risk categories, assessed using the Adult Difficult Intravenous Access (A-DIVA) scoring tool, will be compared between the 18G and 20G cannula groups. The unit of measure is the percentage of participants with successful first-attempt cannulation per A-DIVA risk category (%). The A-DIVA score ranges from 0 to 5, with scores of 0-1 indicating low risk, 2-3 indicating moderate risk, and 4-5 indicating high risk of difficult intravenous access.
Immediately after the first cannulation attempt
Comparison of first-attempt cannulation success rate by patient age between groups
時間枠:Immediately after the first cannulation attempt
The first-attempt cannulation success rate across different age groups, recorded in years at the time of enrollment, will be compared between the 18G and 20G cannula groups. The unit of measure is the percentage of participants with successful first-attempt cannulation per age group (%).
Immediately after the first cannulation attempt
Comparison of first-attempt cannulation success rate by patient sex between groups
時間枠:Immediately after the first cannulation attempt
The first-attempt cannulation success rate by patient sex (male or female), recorded at the time of enrollment, will be compared between the 18G and 20G cannula groups. The unit of measure is the percentage of participants with successful first-attempt cannulation per sex (%).
Immediately after the first cannulation attempt

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

  • 主任研究者:Erhan Altunbas、Marmara University Scholl Of Medicine

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 (実際)

2026年7月23日

一次修了 (実際)

2026年7月30日

研究の完了 (実際)

2026年8月3日

試験登録日

最初に提出

2026年5月13日

QC基準を満たした最初の提出物

2026年6月4日

最初の投稿 (実際)

2026年6月5日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月5日

QC基準を満たした最後の更新が送信されました

2026年8月3日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 09.2026.774

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