Post-Extubation Assessment of Clinical Stability in Extremely Preterm Infants: the PEACE Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Acceptability of the multimodal monitoring approach
研究概览
简要总结
This is an observational, proof-of-concept, feasibility study that aims to evaluate the feasibility of a monitoring system that integrates clinical data, high-resolution waveforms from the bedside monitor, regional oxygenation (via cerebral and splanchnic near-infrared spectroscopy), and regional ventilation (via electrical impedance tomography) from 20 extremely low birth weight infants at high-risk of reintubation.
详细描述
The primary aim of this proof-of-concept study is to evaluate the feasibility and acceptance of a monitoring system that integrates clinical data and biomedical signals from multiple modalities in a cohort of extremely preterm infants at high-risk of clinical instability on non-invasive respiratory support.
Secondary aims will be to longitudinally describe peripheral oxygen saturation, cerebral oxygen saturation, splanchnic oxygen saturation and regional lung ventilation in extremely low birth weight infants with or without reintubation during the 7 days post extubation.
The application of this multimodal monitoring approach using both clinical and physiological data during the postextubation period will help by making the assessment of clinical stability more comprehensive, more objective, more accurate, more standardized, and more reflective of important end-organ function. Thus, the proposed multimodal monitoring could lead to more informed decisions about reintubation and more individualized treatment plans during this critical period, hence potentially leading to better outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 28 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Birth weight < 1000g and gestational age < 28+0 weeks,
- •Received mechanical ventilation within the first 72h of life,
- •Undergoing their first planned extubation within the first 6 weeks of life.
排除标准
- •Congenital anomalies and congenital heart disorders.
结局指标
主要结局
Acceptability of the multimodal monitoring approach
时间窗: 168 hours
Acceptability of the multimodal monitoring approach will be evaluated using short anonymous surveys distributed to parents, bedside nurses, and attending clinicians participating in the study.
Recruitment rate
时间窗: 168 hours
To evaluate the time frame needed to recruit patients and percentage of eligible infants recruited
Consent rate
时间窗: 168 hours
To evaluate the percentage of eligible infants consented
次要结局
- To describe longitudinal peripheral blood oxygen saturation patterns for infants with and without reintubation during the 7 days post-extubation(168 hours)
- To describe longitudinal cerebral oxygen saturation patterns for infants with and without reintubation during the 7 days post-extubation(168 hours)
- To describe longitudinal splanchnic oxygen saturation patterns for infants with and without reintubation during the 7 days post-extubation(168 hours)
- To describe regional lung ventilation from the immediate pre-extubation period until 72-96 hours post-extubation.(96 hours)
研究者
Wissam Shalish
Assistant Professor of Pediatrics, McGill University Neonatologist, Montreal Children's Hospital
McGill University Health Centre/Research Institute of the McGill University Health Centre