Actuated, Low-Stress, Endotracheal Tube Cleaner to Improve Neonate Lung Function

 描述（由申请人提供）：本II期SBIR完成了Neo ET-Clear的开发和临床测试-一种用于改善新生儿肺功能的驱动式低应力气管插管（ETT）清洁剂。Neo ET-Clear从直径为2.5 mm的新生儿气管插管中吸出粘液，与当前方法（包括封闭式吸引系统）相比，对肺功能和力学的有害影响显著降低。公共卫生问题：在美国，每年有107，000名新生儿患者接受气管插管。插管在三级护理转诊点的NICU中特别常见，这些转诊点有大量复杂的早产儿，插管率高达60%。呼吸道中的ETT刺激分泌物并干扰患者的咳痰能力。为了清除分泌物，气管插管定期用吸引导管（每3-6小时）抽吸。正常的抽吸过程对患者来说是非常不舒服和紧张的。这种疼痛和痛苦，当发生在新生儿，可能会影响大脑发育，并导致长期发育迟缓。与标准吸痰相关的直接风险包括肺容量和顺应性损失、去饱和/缺氧（低血氧）、心率降低和脑血流/氧合变化。此外，标准的抽吸导管会将可能含有细菌的分泌物推入呼吸道，增加肺部感染的风险。反复吸痰的潜在长期风险包括隐匿性肺不张引起的慢性肺病和由于血氧大幅波动引起的早产儿视网膜病变。需要一种用于清除新生儿ETT的装置，其减少标准抽吸方法对短期和长期患者健康以及对肺功能的有害副作用。Neo ET-Clear是一种驱动式封闭吸引系统，设计用于安全有效地吸引接受机械通气的新生儿和儿科患者。Neo ET-Clear吸引杆采用可控的温和振动和内部冲洗，有助于粘液清除。将延长杆插入患者的气管插管中并从其中取出-类似于标准封闭吸引导管。第I阶段项目符合所有特定目标，证明Neo ET-Clear在2.5 mm ETT封闭吸引期间显著降低了对测试模型肺力学的影响（吸入潮气量维持2- 3倍，PEEP损失仅为10%，而不是70%），同时与标准5 Fr封闭吸引导管相比，实现了相同的粘液清除和潮气量恢复。来自NICU临床医生的反馈非常热情。第二阶段-假设：Neo ET-Clear可安全用于新生儿患者，并可减少吸痰对血氧、肺力学和患者痛苦的负面影响。目的1 -将设计和安全特性纳入并确认到Neo ET-Clear中不会影响有益的抽吸效率结果。目的2 -通过临床前试验证明Neo ET-Clear的安全性和改善的生理结局。目标3 -初步人体临床评价（费城儿童医院，n=10）。

 DESCRIPTION (provided by applicant): This Phase II SBIR finalizes development and clinically tests Neo ET-Clear - an Actuated, Low-Stress, Endotracheal Tube (ETT) Cleaner to Improve Neonate Lung Function. Neo ET-Clear suctions mucus from 2.5 mm diameter neonatal endotracheal tubes with significantly reduced deleterious impact on lung function and mechanics, as compared to current methods, including Closed Suction Systems. Public Health Problem: ETTs are placed in 107,000 neonatal patients annually in the U.S. Intubation is particularly common in NICUs in tertiary care referral sites, which see a high number of complicated premature neonates, and intubation rates as high as 60%. The ETT in the respiratory tract stimulates secretions and interferes with the patient's ability to expectorate. T remove secretions, ETTs are regularly aspirated with suction catheters (every 3-6 hours). The normal suctioning procedure is extremely uncomfortable and stressful to the patient. Such pain and distress, when occurring in neonates, can affect brain growth and lead to long-term developmental delays. Immediate risks associated with standard suctioning include loss of lung volume and compliance, desaturation/hypoxia (low blood oxygen), decreased heart rate, and changes in cerebral blood flow/oxygenation. Furthermore, standard suction catheters can push secretion material, possibly containing bacteria, into the respiratory tract, increasing the risk o lung infection. Potential long-term risks of repeated suctioning include chronic lung disease from occult atelectasis and retinopathy of prematurity due to large fluctuations in blood oxygen. A device is needed for clearing neonatal ETTs that reduces the harmful side-effects of standard suctioning methods on short and long-term patient health, and on lung function. Neo ET-Clear is an actuated closed suction system designed to safely and effectively suction neonatal and pediatric patients on mechanical ventilation. The Neo ET-Clear Suction Stem incorporates a controlled gentle vibration with internal irrigation that facilitates mucus removal. The Stem is inserted in and out of the patient's ETT - similar to standard closed Suction Catheter. The Phase I project met all Specific Aims, demonstrating that Neo ET-Clear dramatically reduced effects on test-model lung mechanics (2-3x better maintenance of inspired Tidal Volume, and PEEP loss of only 10% compared to 70%) during closed suctioning of 2.5 mm ETTs, while achieving equal mucus removal and tidal volume restoration compared to standard 5 Fr Closed Suction Catheters. Feedback from practicing NICU clinicians was extremely enthusiastic. Phase II - Hypothesis: Neo ET-Clear is Safe for use in Neonatal Patients and Reduces the Negative Impact of Suctioning on Blood Oxygen, Lung Mechanics, and Patient Distress. Aim 1 - Incorporation and validation of design and safety features into Neo ET-Clear does not impact beneficial suctioning efficiency results. Aim 2 - Demonstrate Safety and Improved Physiologic Outcomes with Neo ET-Clear through Pre-Clinical Testing. Aim 3 - Pilot Human Clinical Evaluation (Children's Hospital of Philadelphia, n=10).