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临床试验/NCT07629427
NCT07629427已完成不适用

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

Marmara University Pendik Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 204 人开始时间: 2026年7月23日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
204
试验地点
1

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

20G Cannula Group

Active Comparator

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.

干预措施: 20-gauge peripheral intravenous cannula (Device)

18G Cannula Group

Active Comparator

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.

干预措施: 18-gauge peripheral intravenous cannula (Device)

研究者

发起方
Marmara University Pendik Training and Research Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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