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临床试验/NCT06465121
NCT06465121
招募中
不适用

Difficult Venous Access in Pediatric Patients: Paramedical Care Using Ultrasound Guidance

CHU de Reims1 个研究点 分布在 1 个国家目标入组 120 人2026年2月17日

概览

阶段
不适用
干预措施
peripheral intravenous catheterization performed with ultrasound guidance by a trained nurse
疾病 / 适应症
Catheter Related Complication
发起方
CHU de Reims
入组人数
120
试验地点
1
主要终点
Number of Participants with success at first intravenous catheter insertion attempt
状态
招募中
最后更新
2个月前

概览

简要总结

Obtaining intravenous access is difficult in the pediatric population. Ultrasound-guidance allows real-time visualization of target veins which are invisible and impalpable. We hypothesize that the use of ultrasound by a trained nurse team would improve the success rate of peripheral intravenous catheter insertion in pediatric patients with difficult intravenous access, compared to palpation of the vein alone.

For this study, when peripheral intravenous catheterization will be indicated in one of the participating pediatric services for an eligible patient, state-certified nurse investigators, trained in ultrasound guidance, will be contacted. After verification of eligibility criteria and all informed consents obtained, one of the investigators will randomize the patient in one of the 2 treatment groups under study: peripheral intravenous catheterization by visualization and palpation of the vein alone (standard of care) or by ultrasound guidance performed by a trained nurse.

Several outcomes will be measured and compared between the 2 groups (e.g. successful insertion of intravenous catheter, pain, adverse events).

详细描述

Venipunctures are very common in hospitalized patients. Obtaining venous access is more difficult in the pediatric population, particularly due to the smaller size of the vessels and the more difficult cooperation of patients. Traditional method for inserting intravenous catheter access requires knowledge of vascular anatomy to estimate the location of the target vein and requires visualization or palpation of the vein. The success rate for peripheral intravenous catheterization in pediatric patients is approximately 60% after one attempt and 90% after four. Delays in intravenous access can result in significant morbidity and mortality. Thus, alternative methods should be considered to improve pediatric access sites. Ultrasound-guidance allows real-time visualization of target veins which are invisible and impalpable. We hypothesize that the use of ultrasound by a trained nurse team would improve the success rate of peripheral intravenous catheter insertion in pediatric patients with difficult intravenous access. This could also have an impact on the frequency of the main associated adverse events. For this study, when peripheral intravenous catheterization will be indicated in one of the participating pediatric services for an eligible patient, state-certified nurse investigators, trained in ultrasound guidance, will be contacted. After verification of eligibility criteria and all informed consents obtained, one of the investigators will randomize the patient in one of the 2 treatment groups under study: peripheral intravenous catheterization by visualization and palpation of the vein alone (standard of care) or by ultrasound guidance performed by a trained nurse. Several outcomes will be measured and compared between the 2 groups (e.g. successful insertion of intravenous catheter, pain, adverse events). Children will be followed for a maximum of 7 days or until discharge from hospitalization.

注册库
clinicaltrials.gov
开始日期
2026年2月17日
结束日期
2027年9月1日
最后更新
2个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
CHU de Reims
责任方
Sponsor

入排标准

入选标准

  • age ≥ 1 month and \< 18 years
  • intravenous catheter insertion indicated for hospital care
  • DIVA (Difficult Intravenous Access Scale) score ≥ 4
  • hospitalized in one of the pediatric departments of the Reims University Hospital
  • who agree to participate in the study (if old enough to understand) and for whom the consent of the holder(s) of parental authority has been obtained
  • affiliated to a social security scheme

排除标准

  • Newborns (\< 1 month) and premature babies hospitalized in neonatal intensive care, neonatology and maternity units
  • Known vascular pathology
  • Hemodialysis with arteriovenous fistula
  • Unstable hemodynamic and/or respiratory clinical state according to the judgment of the medical team

研究组 & 干预措施

Ultrasound guidance

peripheral intravenous catheterization performed with ultrasound guidance by a trained nurse

干预措施: peripheral intravenous catheterization performed with ultrasound guidance by a trained nurse

Standard of care

Peripheral intravenous catheterization by visualization and palpation of the vein alone

结局指标

主要结局

Number of Participants with success at first intravenous catheter insertion attempt

时间窗: Day 0

Success at first attempt of intravenous catheter insertion with ultrasound-guidance compared to standard of care for pediatric patients with difficult venous access

研究点 (1)

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