Physiological Changes With High-Flow Nasal Cannula Compared to Nasal CPAP in Extremely Low Birth Weight Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- % Unventilated Lung
研究概览
简要总结
To measure changes in physiologic parameters in extremely low birthweight (ELBW) infants on high-flow nasal cannula compared to nasal continuous positive airway pressure (nCPAP).
详细描述
After informed consent is obtained, eligible infants who are stable on nCPAP therapy of 5-7 cm H20 achieved with a ventilator, an underwater "bubble" system, or a variable-flow device will be enrolled.
All subjects will have physiologic data and electrical impedance tomography collected at:
- Baseline nCPAP for 15 minutes
- Upon transition to high flow nasal cannula at 8 LPM for 6 hours. Data collection is obtained after infant is calm for 15 minutes at the beginning and end of this 6 hour period
- Then upon return to baseline NCPAP for a final 15 minutes of data collection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 23 Weeks 至 28 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •23 to 28+6 weeks gestational age at birth
- •Corrected gestational age less than or equal to 30 weeks
- •Over 72 hours of life
- •Stable on Nasal CPAP of 5-7cm H20
- •Hemodynamically stable
- •Tolerating routine handling
- •Nares size appropriate for Fisher & Paykel Optiflow Jr 2 HFNC size XS or small
- •Successfully extubated for 12 hours after administration of surfactant
- •Caffeine Citrate at a maintenance dose of 5 to 10 mg /kg
- •Transcutaneous monitoring in place
- •Stable blood gas (pH>/= 7.25 and PaCO2 <60 mmHg torr)
排除标准
- •Prior pneumothorax or evidence of pulmonary interstitial emphysema.
- •Prior or current pulmonary hemorrhage
- •Congenital airway malformations
- •Major cardiopulmonary malformations
- •Congenital Diaphragmatic hernia or untreated bowel obstruction
- •Poor respiratory drive unresponsive to CPAP therapy
- •Requirement of a nCPAP of >8 cmH20 or FiO2 > 0.3 to maintain oxygen saturations between 90-95 percent.
- •Receiving positive pressure breaths or SIPAP on prongs
- •Conflicting clinical trial
- •Clinically unstable per physician discretion
研究组 & 干预措施
Nasal CPAP - Period 1
Eligible infants stable on high flow nasal cannula (nCPAP) therapy of 5-7 cm H20 achieved with a ventilator, an underwater "bubble" system, or a variable-flow device will be enrolled. A data acquisition cart will be placed at the subject's bedside to collect hemodynamic and respiratory parameters measured including: Heart rate (HR), blood pressure (BP), respiratory rate (RR), fraction of inspired oxygen (FiO2), transcutaneous carbon dioxide (TcCO2), and peripheral oxygen saturation (SpO2) via bedside monitoring devices. A neonatal chest belt, sized to the infant's chest circumference (nipple level) using warmed ultrasound gel applied to the belt beforehand, will collect regional lung volume measurements using electrical impedance tomography (EIT). Subject video recording will capture apnea events and the interventions used to resolve them such as positive pressure ventilation, repositioning, or stimulation. Data will be collected for 15 minutes on nCPAP.
干预措施: Nasal CPAP (Procedure)
High Flow Nasal Cannula (HFNC) - Period 2 & 3
Respiratory support will be crossed over to a HFNC Optiflow Jr 2 (Fisher & Paykel Healthcare, Auckland, New Zealand) at a flow rate of 8 LPM. The size of the nasal cannula will be determined according to the manufacturer's instructions in order to maintain a leak at the nares. Identical data collection will occur for two 15 minute periods on HFNC, at the beginning and end of the six hour Study period.
Nasal CPAP - Period 4
After 6 hours of HFNC of 8 LPM, or sooner if the infant meets failure criteria, the infant will then be crossed back to the nCPAP device and at the settings previously utilized in Study Period 1. The infant will remain on the nCPAP device with identical data collection for 15 minutes. The total duration of the study and data collection will be 8 hours. The infant's body position will be similar for each lung volume measurement during the study periods.
干预措施: Nasal CPAP (Procedure)
结局指标
主要结局
% Unventilated Lung
时间窗: Through study completion, an average of 30 days
Atelectasis will be calculated using the percentage of the lung fields that are not engaged in tidal volume.(VT)
Percent of Unventilated Lung as Assessed by Electrical Impedance Tomography
时间窗: Primary outcome was measured during each study period: baseline on nCPAP, 30 minutes after starting HFNC, at 6 hours on HFNC or earlier if failure, and 60 minutes after returning to nCPAP.
Atelectasis will be calculated using the percentage of the lung fields that are not engaged in tidal volume.(VT) In Period 1 (nCPAP Baseline), infants on nCPAP at 5-7 cmH₂O in the supine position underwent up to 15 minutes of quiet-breathing EIT recording. In Period 2 (30 min on HFNC), infants were transitioned to HFNC at 8 L/min, and if tolerated, up to 15 minutes of EIT were collected at \~30 minutes. In Period 3 (6 hr on HFNC or earlier if failure), infants who tolerated HFNC underwent EIT at 6 hours; those meeting failure criteria returned immediately to nCPAP and were analyzed as Period 3 without a 6-hour EIT. In Period 4 (60 min after return to nCPAP), infants resumed nCPAP and up to 15 minutes of EIT were obtained about 60 minutes later. In period 4 one participant had missing primary outcome data and were analyzed as Period 4 without a 60 min return to nCPAP EIT measurement.
次要结局
- Geometric Center of Ventilation (CoV)(Through study completion, an average of 30 days)
- End-expiratory lung volume(Through study completion, an average of 30 days)
- Geometric Center of Ventilation (CoV) - Ventral Dorsal(This secondary outcome was measured during each study period: baseline on nCPAP, 30 minutes after starting HFNC, at 6 hours on HFNC or earlier if failure, and 60 minutes after returning to nCPAP.)
- End-expiratory Lung Impedance(This secondary outcome was measured during each study period: baseline on nCPAP, 30 minutes after starting HFNC, at 6 hours on HFNC or earlier if failure, and 60 minutes after returning to nCPAP.)
- Relative Tidal Stetch(This secondary outcome was measured during each study period: baseline on nCPAP, 30 minutes after starting HFNC, at 6 hours on HFNC or earlier if failure, and 60 minutes after returning to nCPAP.)
- Oxygenation Ratio(Study Period 1 through 4)
研究者
Anup Katheria, M.D.
Director Neonatal Research Institute
Sharp HealthCare