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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.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

204

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

      • Istanbul, 터키 (Türkiye)
        • Marmara University Pendik Training and Research Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 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.
활성 비교기: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Pain intensity
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
First-attempt cannulation success rate
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 수석 연구원: Erhan Altunbas, Marmara University Scholl Of Medicine

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 7월 23일

기본 완료 (실제)

2026년 7월 30일

연구 완료 (실제)

2026년 8월 3일

연구 등록 날짜

최초 제출

2026년 5월 13일

QC 기준을 충족하는 최초 제출

2026년 6월 4일

처음 게시됨 (실제)

2026년 6월 5일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 5일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 3일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 09.2026.774

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아니요

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