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临床试验/NCT05147922
NCT05147922已完成不适用

Neo RQI: Evaluating the Effect of Neonatal Resuscitation Quality Improvement Cart Booster Training on Provider Positive Pressure Ventilation Skills Retention

University of Texas Southwestern Medical Center2 个研究点 分布在 1 个国家目标入组 155 人开始时间: 2022年4月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
155
试验地点
2
主要终点
Mask Leak

研究概览

简要总结

This is a prospective multicenter randomized control trial to assess percentage mask leak six months post instructor led positive pressure ventilation skills training in providers who undergo booster training compared to those who do not undergo any booster training

详细描述

Baseline positive pressure ventilation skill assessment of all study participants: Site principal investigators will recruit eligible providers for the trial. Participants will fill out study enrollment sheet which will ask for 1. Demographic information 2. Profession 3. Experience (number of times positive pressure ventilation performed on a newborn in the last 6 months) 4. Last time Neonatal Resuscitation Program course attended and 5. Institution. Participants will perform 1 minute of positive pressure ventilation on the cart. During this baseline assessment, there is no audio-visual feedback or display. The cart will record data on mask leak, pressure used, ventilation rate, head positioning.

Pre-randomization Standardized Instructor Led Skills Training: All study participants will undergo the standard instructor-led positive pressure ventilation skills training. Each site will have a designated study instructor who will remain blinded to the baseline positive pressure ventilation skill assessment data. Study instructors will use a standardized script as a guide for the instructor led positive pressure ventilation skills training. This training will occur with the same manikin and equipment as the one available at the cart. This training will decrease the impact of variability in prior training received by the study participants.

Post- Instructor led positive pressure ventilation skills training Assessment: Immediately after the instructor led training, participants will perform 1-minute positive pressure ventilation on the cart. This will also be a blinded assessment without any display or feedback. Comparison of pre- and post- instructor led training assessments will provide unique data to evaluate if instructor led training changes the positive pressure ventilation skills.

Randomization with minimization procedure: Randomization will be provided by a secure website using the computer-generated randomization and the minimization procedure. The goal of the minimization procedure is to prevent an imbalance of factors that may influence positive pressure ventilation skill retention. Factors that will be taken into account during minimization procedure are

  1. PPV skill proficiency during baseline pre-instructor led training assessment: Based on the pre-training skill assessment, each participant will be coded as a Group A [Proficient] or Group B [not proficient]. Participants will be considered proficient if participants are able to achieve low mask leak (< 30%) on >80% of ventilations provided. Only study Principal investigator and research nurse will have access to this data. 2. Profession 3. Experience (number of times positive pressure ventilation performed on a newborn in the last 6 months) 4. Last time NRP course attended and 5. Institution. Based on this information, the randomization website will assign them to the intervention (booster training) or control group (no booster training) with 1:1 allocation.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Any Neonatal Resuscitation Program-card carrying provider at the participating sites (University of Texas Southwestern, Stanford University and St. Louis University).

排除标准

  • Novice providers, who have never taken an Neonatal Resuscitation Program course, will be excluded as participant may not be familiar with the equipment to initiate positive pressure ventilation skills without a face-to-face interaction with an instructor

研究组 & 干预措施

Booster Training Group

Experimental

Participants randomized to intervention will undergo booster training sessions with the RQI cart (including audiovisual feedback) at 3, 6 and 9 months post instructor-led training session. Following each of these booster sessions, the participants will undergo 1 minute assessments, without feedback.

干预措施: Booster Training with the Neonatal Resuscitation Quality Improvement Cart (Behavioral)

No Booster Training Group

No Intervention

Participants randomized to the control group will undergo 1 minute assessments, without feedback, at 6 and 9 months. Participants will not be able to access the RQI cart outside of their assessment.

结局指标

主要结局

Mask Leak

时间窗: 6 months after initial enrollment and instructor-led training session

The primary outcome of the study is the proportion of subjects who provide \>80% ventilation with low mask leak (\< 30% mask leak) during the one-minute assessment at six months from the instructor led positive pressure ventilation skills training

次要结局

  • Peak Inspiratory Pressure score(6 month and 9 month assessments)
  • Tidal volumes(6 month and 9 month assessments)
  • Positive Pressure Ventilation composite score(6 month and 9 month assessments)
  • Rate score(6 month and 9 month assessments)
  • Positive End Expiratory Pressure score(6 month and 9 month assessments)

研究者

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

Vishal Kapadia

Associate Professor- Pediatrics

University of Texas Southwestern Medical Center

研究点 (2)

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