Ventilator Pressure and Optimization of Compliance and Hemodynamics: VPOCH Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- PEEP of best compliance and best oxygenation as per EIT measurements
研究概览
简要总结
In preterm infants < 34 weeks' gestation at birth receiving respiratory support with invasive positive pressure ventilation, the positive end-expiratory pressure (PEEP) of best compliance will increase the cardiac output and improve oxygenation. This study may emphasize using point-of-care echocardiography along with electrical impedance tomography (EIT) to optimize ventilator settings in preterm infants.
Infants will be randomized to a 4-hour crossover period of increasing and decreasing PEEP in random order from baseline to determine compliance, oxygenation, and cardiac hemodynamics at each step using echocardiography (ECHO) and EIT measurements. There will be a 15-minute washout period after changes prior to data collection.
详细描述
In preterm infants < 34 weeks' gestation at birth receiving respiratory support with invasive positive pressure ventilation, the positive end-expiratory pressure (PEEP) of best compliance will increase the cardiac output and improve oxygenation. This study may emphasize using point-of-care echocardiography along with EIT to optimize ventilator settings in preterm infants.
Neonatal ventilation is a critical intervention to support breathing for newborns with respiratory distress syndrome (RDS), underdeveloped lungs, and evolving bronchopulmonary dysplasia (BPD). Positive airway pressure helps maintain patency of the airways and improves ventilation and oxygenation by maintaining the functional residual capacity (FRC) and keeping the alveoli patent. Peak inspiratory pressure (PIP) and positive end-expiratory pressure (PEEP) are terms commonly used in mechanical ventilation to describe the pressures applied to the respiratory system during the different phases of the breathing cycle. These parameters are essential in managing and optimizing ventilation for infants with respiratory failure.
This study will include preterm infants with recovering RDS born at age < 34 weeks of gestational age on respiratory support via conventional mechanical ventilation or on high-frequency jet ventilation (HFJV). Infants will be randomized to the order of testing, increasing the PEEP (+1 cmH2O and +2 cmH2O) or decreasing the PEEP (+1 cmH2O and +2 cmH2O) with baseline measurements and Echo done at original PEEP and each subsequent PEEP.
Following informed consent, randomization will be performed using sequentially numbered sealed opaque envelopes. The randomization envelope will be signed before it is opened just before starting the study on each infant to indicate the first intervention for the infant.
This will be a single-center, randomized crossover study. The randomization envelope will be signed before it is opened just before starting the study on each infant to indicate the first intervention for the infant.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 7 Days 至 30 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants with recovering respiratory distress syndrome (RDS) who were born at a gestational age < 34 weeks and are receiving respiratory support via conventional mechanical ventilation or on HFJV.
- •Post-natal age > 7 days and less than 1 month (outside golden week protocol)
- •Gestational age ≥ 21 weeks and ≤ 34 week
- •Infants with written informed consent obtained from legal guardian
排除标准
- •Blood culture-positive sepsis
- •Congenital anomalies affecting respiration
- •Cyanotic or ductal-dependent congenital heart disease
- •Newborns who are considered too unstable for study enrolment per neonatology attending
- •Newborns on pressors or steroids for maintaining cardiac output
- •Non-invasive ventilation or newborn with significant BPD (bronchopulmonary dysplasia) with pulmonary hypertension (HTN)
- •Open skin wounds or abrasions on the chest wall.
研究组 & 干预措施
cardiac hemodynamics and respiratory status assessment with increasing PEEP
Infants will be randomized to the order of changes in PEEP levels during mechanical ventilation - increase followed by decrease in PEEP.
Baseline parameters looking into cardiac hemodynamics as well as compliance and respiratory mechanics will be assessed using EIT
干预措施: Increase in the PEEP followed by decrease in the PEEP (Other)
cardiac hemodynamics and respiratory status assessment with decreasing PEEP
Infants will be randomized to the order of changes in PEEP levels during mechanical ventilation - decrease followed by increase in PEEP.
Baseline parameters looking into cardiac hemodynamics as well as compliance and respiratory mechanics will be assessed using EIT
干预措施: Decrease in the PEEP followed by increase in the PEEP (Other)
结局指标
主要结局
PEEP of best compliance and best oxygenation as per EIT measurements
时间窗: During a 4 hour cross-over period on either intervention
Change in cardiac index with increase/decrease in PEEP as measured by ECHO and EIT
时间窗: During a 4 hour cross-over period on either intervention
次要结局
- Oxygen saturation index(During a 4 hour cross-over period on either intervention)
- Tidal volume variation(During a 4 hour cross-over period on either intervention)
- Respiratory Severity Score (RSS)(During a 4 hour cross-over period on either intervention)
- End-expiratory lung impedance (EELI), End-inspiratory lung impedance (EILI)(During a 4 hour cross-over period on either intervention)
- Transcutaneous carbon dioxide (TcCO2) values in response to varying PEEP levels(During a 4 hour cross-over period on either intervention)
- % tidal distribution(During a 4 hour cross-over period on either intervention)
- oxygen saturation (SpO2) values(During a 4 hour cross-over period on either intervention)
研究者
Kulsajan Singh Bhatia
Neonatal Perinatal Fellow
University of Alabama at Birmingham