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临床试验/NCT05399628
NCT05399628已完成不适用

LISA Catheter With Marked vs. Unmarked Tip in Extremely Low Birth Weight Infants With RDS: a Crossover Randomized Controlled Manikin Trial

University Hospital Padova2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年6月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Number of participants who will achieve the positioning of the device at the correct depth in the trachea

研究概览

简要总结

This is an unblinded, randomized, controlled, crossover (AB/BA) trial of surfactant treatment with LISA catheter with a marked tip vs. LISA catheter with an unmarked tip in a manikin simulating an extremely low birth weight infant. Participants will be level III NICU consultants and residents. Randomization will be performed using a computer-generated random assignment list. The primary outcome measure will be the positioning of the device at the correct depth in the trachea. The secondary outcome measures will be the time and number of attempts to achieve the correct depth and participant satisfaction.

详细描述

Although less invasive surfactant administration (LISA) offers some advantages in ventilation procedure and neonatal outcomes, achieving the correct depth in the trachea using a LISA catheter may be difficult. This may have some drawbacks such as impaired surfactant administration (reducing the efficacy of the procedure) or prolonged duration of the laryngoscopy (aggravating the invasiveness of the procedure).

The aims of the present study should be: i) positioning of the device at the correct depth in the trachea, ii) time and number of attempts to achieve the correct depth, iii) participant satisfaction.

This is an unblinded, randomized, controlled, crossover (AB/BA) trial of surfactant treatment with LISA catheter with a marked tip vs. LISA catheter with an unmarked tip in a manikin simulating an extremely low birth weight infant. Participants will be level III NICU consultants and residents. Randomization will be performed using a computer-generated random assignment list. The primary outcome measure will be the positioning of the device at the correct depth in the trachea. The secondary outcome measures will be the time and number of attempts to achieve the correct depth and participant satisfaction.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

盲法说明

Due to the characteristics of the intervention, both participants and outcome assessors cannot be masked. The statistician will be blind to the intervention arms.

入排标准

性别
All
接受健康志愿者

入选标准

  • Level III NICU consultants and residents will be eligible to participate in the study

排除标准

  • Refusal to participate in the study.

结局指标

主要结局

Number of participants who will achieve the positioning of the device at the correct depth in the trachea

时间窗: 5 minutes

Number of participants who will achieve the positioning of the device at the correct depth in the trachea (as assessed by the external observer using a laryngoscope).

次要结局

  • Participant opinion on using the device(10 minutes)
  • Number of attempts for positioning the device in the trachea(5 minutes)
  • Time for positioning the device in the trachea(5 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniele Trevisanuto

Associate Professor

University Hospital Padova

研究点 (2)

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