Respiratory function monitoring during resuscitation of extremely preterm infants: An ancillary study to the SAIL trial

极早产儿复苏期间的呼吸功能监测：SAIL 试验的辅助研究

• 批准号: 9181219
• 负责人: Elizabeth Foglia
• 金额: $ 8.54万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-07 至 2018-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9181219
• 关键词: Acute; Acute Lung Injury; Ancillary Study; Benefits and Risks; Birth; Breathing; Bronchopulmonary Dysplasia; Carbon Dioxide; Cessation of life; Characteristics; Chest; Chronic; Clinical; Data; Delivery Rooms; Economic Inflation; Enrollment; Environmental air flow; Exhalation; Failure; Fetal Lung; Functional Residual Capacity; Funding; Goals; Hour; Incidence; Infant; Intermittent Positive-Pressure Ventilation; International; Intratracheal Intubation; Intubation; Life; Liquid substance; Lung; Masks; Measures; Mechanical ventilation; Mechanics; Methods; Monitor; National Institute of Child Health and Human Development; Neonatal; Newborn Infant; Outcome; Physiological; Positive-Pressure Respiration; Premature Infant; Process; Production; Randomized Controlled Trials; Research; Research Priority; Respiratory Mechanics; Respiratory physiology; Resuscitation; Risk; Site; Study Subject; Tidal Volume; Time; Trauma; airway obstruction; cohort; effectiveness measure; improved; innovation; lung injury; neonatal resuscitation; novel; pressure; prevent; programs; randomized trial; respiratory; surfactant; tool

PROJECT SUMMARY/ABSTRACT Lung aeration is the most critical physiologic task for the preterm infant to achieve after birth for survival. Yet the optimal method of aerating the preterm lung remains unknown. After birth, the newborn must rapidly open the lungs to clear the fetal lung liquid and establish a Functional Residual Capacity (FRC). There are two strategies to achieve this goal: Intermittent Positive Pressure Ventilation (IPPV) with positive end expiratory pressure (PEEP), and Sustained inflation (SI). It is not yet known which strategy is superior for lung aeration after birth. Further, performing non-invasive (i.e., facemask) respiratory support is technically difficult in preterm infants. The impact of common problems, such as facemask leak and airway obstruction, on the need for rescue endotracheal intubation is unknown. The objectives of this project are to (1) assess the effect of SI and IPPV on direct measures of lung aeration, and (2) to determine the impact of measured respiratory mechanics, such as mask leak, airway obstruction, and delivered tidal volumes, on need for rescue intubation in extremely preterm infants during delivery room resuscitation. To accomplish these objectives, this proposal will use a respiratory function monitor (RFM) to directly measure indicators of lung aeration in preterm infants during delivery room resuscitation. A RFM is a novel research tool that measures and displays respiratory characteristics of delivered inflations in real time. This project is an ancillary study of the SAIL trial (Sustained Aeration of Infant Lungs, Clinicaltrials.gov identifier NCT02139800), an ongoing international randomized controlled trial of SI versus IPPV as the initial lung aeration strategy in extremely preterm infants. RFM is an innovative tool to measure pulmonary mechanics during delivery room resuscitation. The SAIL trial will be the largest randomized trial of SI versus IPPV performed in extremely preterm infants to date. This project will take advantage of the existing SAIL trial framework and use RFM to identify the optimal approach to aerate the preterm lung after birth.

项目摘要/摘要 肺曝气是早产儿在生存后实现的最关键的生理任务。然而 充气早产肺的最佳方法仍然未知。出生后，新生儿必须迅速开放 肺清除胎儿肺液体并建立功能性残留能力（FRC）。有两个 实现这一目标的策略：间歇性正压通风（IPPV），并具有正末期呼气 压力（窥视）和持续通胀（SI）。尚不清楚哪种策略优越 出生后。此外，在技术上很难执行非侵入性（即面部面包）呼吸支持 早产婴儿。常见问题的影响，例如Facemask泄漏和气道阻塞对需求的影响 为了救援，气管气管插管尚不清楚。 该项目的目标是（1）评估SI和IPPV对肺气直接测量的影响， （2）确定测得的呼吸机械的影响，例如掩模泄漏，气道阻塞， 并交付了潮汐量，在分娩室期间需要在极早产的婴儿中救援插管 复苏。 为了实现这些目标，该提案将使用呼吸函数监视器（RFM）直接测量 在分娩室复苏期间，早产儿的肺气曝气指标。 RFM是一项新型研究 测量和显示实时交付通货膨胀的呼吸特征的工具。这个项目是一个 辅助试验的辅助研究（持续的婴儿肺曝气，临床Trialtrials.gov标识符NCT02139800）， SI与IPPV的一项正在进行的国际随机对照试验是最初的肺气曝气策略 非常早产的婴儿。 RFM是在输送室复苏期间测量肺力学的创新工具。帆试验 迄今为止，将是在极早的婴儿中进行的SI与IPPV的最大随机试验。这 项目将利用现有的帆试验框架，并使用RFM确定最佳方法 出生后的早产肺。