Post-extubation Pressures on Non-invasive Respiratory Support in Preterm Neonates: A Prospective Comparative Effectiveness Research Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,050
- 主要终点
- Re-intubation within 7 days post-extubation
研究概览
简要总结
The optimal post-extubation pressure level on non-invasive respiratory support modes - irrespective of the choice of the specific non-invasive mode - that optimizes extubation success and improves clinical outcomes remains unknown.
The investigators aim to determine the optimal initial non-invasive pressure support level post-extubation in preterm neonates, in relation to the pre-extubation measured mean airway pressures (Paw). The hypothesis is that use of higher pressures will lead to fewer re-intubations.
This will be a prospective comparative effectiveness study across participating tertiary NICUs across Canada. Centres will self-select whether to use Higher or Equal/Lower pressure levels as well as the initial post-extubation mode (NIPPV or CPAP) for the study duration. Only the first eligible extubation will be included for analysis. Eligible patients <28 weeks' gestational age at birth undergoing an eligible extubation (from a mean airway pressure </= 13 cmH2O) will be included. The primary outcome will be re-intubation within 7 days. Secondary outcomes will include other neonatal morbidities.
详细描述
BACKGROUND Invasive mechanical ventilation (IMV) is a well-established risk factor for bronchopulmonary dysplasia and associated long-term complications. In recent years, a large body of research has evaluated and helped establish clinical practices aimed at avoiding initiation of IMV altogether by using non-invasive respiratory support modes such as CPAP in place of routine intubation and use of minimally invasive surfactant treatment. Despite such efforts, ~85% of preterm neonates <280 weeks' gestational age require IMV [Canadian Neonatal Network data - unpublished]. Furthermore, ~25% of preterm neonates extubated to non-invasive support ultimately require re-intubation [Canadian Neonatal Network data - unpublished], which itself is associated with complications including mortality and bronchopulmonary dysplasia. As such, further research on strategies to facilitate successful extubation is required. While there has been a considerable focus on comparing various modes of non-invasive support following extubation, there are limited published data on peri-extubation practices, particularly as they relate to the choice of post-extubation pressure levels.
In the meantime, there is considerable practice variability in choice of initial settings on both CPAP and NIPPV. A national-level survey (unpublished) demonstrated an almost even split - with half the sites choosing equal or lower pressures, whereas others choosing slightly higher pressures on the initial non-invasive respiratory support compared to pre-extubation pressures on IMV. As such, while the optimal post-extubation pressure level on non-invasive respiratory support that optimizes extubation success and clinical outcomes remains unknown, this natural practical variability affords a unique opportunity to conduct this comparative effectiveness research study using real-world data.
OBJECTIVE To determine the optimal initial non-invasive respiratory pressure support level following extubation in preterm neonates.
HYPOTHESIS The hypothesis is that higher pressures will lead to fewer re-intubations.
SPECIFIC RESEARCH QUESTION
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm neonates GA <28 weeks' gestation, admitted to a participating centre who received any duration of mechanical ventilation.
排除标准
- •Major chromosomal/genetic/congenital abnormalities
- •Never received invasive mechanical ventilation (IMV)
- •Received IMV, but never extubated to non-invasive respiratory support (NRS)
- •Transferred to non-participating site while intubated
- •Death prior to extubation
- •Initial extubation was for withdrawal of care
- •Lack of any eligible extubation, eligible defined as ALL of the following: (i) ≥36 continuous hours on IMV; (ii) pre-extubation MAP ≤13 cmH2O; and (iii) on post-extubation NRS for ≥1 hour.
结局指标
主要结局
Re-intubation within 7 days post-extubation
时间窗: 7 days
次要结局
- New gastro-intestinal perforation (any cause) within 7 days of extubation(7 days)
- Mortality(During initial hospitalization (up to a maximum of 60 weeks' postmenstrual age))
- Moderate to Severe Bronchopulmonary Dysplasia(until 36 weeks' postmenstrual age (or discharge if sooner))
- Post-extubation days on invasive mechanical ventilation(During initial hospitalization (up to a maximum of 60 weeks' postmenstrual age))
- Presence of any 1 or more predefined intubation criteria(7 days)
- Composite of Mortality OR moderate to severe bronchopulmonary dysplasia(During initial hospitalization (up to a maximum of 60 weeks' postmenstrual age))
- Post-extubation days on any form of positive pressure respiratory support(During initial hospitalization (up to a maximum of 60 weeks' postmenstrual age))
- Failure of initial NRS (non-invasive respiratory support) mode(7 days)
- New pulmonary air leak including pneumothorax, pulmonary interstitial emphysema, and/or pneumo-mediastinum within 7 days of extubation(7 days)
- Necrotizing enterocolitis diagnosed any time post-extubation(During initial hospitalization (up to a maximum of 60 weeks' postmenstrual age))
研究者
Amit Mukerji
Associate Professor and Staff Neonatologist
McMaster Children's Hospital