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

 描述(由申请人提供)：这项第二阶段的SBIR最终完成了开发和临床测试Neo ET-Clear-一种驱动的，低压力，气管内管(ETT)清洁剂，以改善新生儿肺功能。Neo ET-Clear从直径2.5 mm的新生儿气管导管中抽吸粘液，与目前的方法(包括封闭式抽吸系统)相比，显著减少了对肺功能和机械性能的有害影响。公共卫生问题：在美国，每年有107,000名新生儿接受ETT。插管在三级护理转诊地点的NICU中尤其常见，那里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，干扰患者的排痰能力。要清除分泌物，应定期用吸管抽吸ETT(每3-6小时一次)。正常的抽吸程序对患者来说是非常不舒服和有压力的。当这种疼痛和痛苦发生在新生儿身上时，可能会影响大脑发育，并导致长期的发育迟缓。与标准吸引术相关的直接风险包括肺容量和顺应性丧失、减饱和/低氧(低血氧)、心率减慢和脑血流/氧合变化。此外，标准的吸引管可能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部疾病，以及由于血氧大幅波动而导致的早产儿视网膜病变。需要一种清除新生儿ETT的设备，以减少标准吸引方法对患者短期和长期健康以及对肺功能的有害副作用。NEO ET-Clear是一种驱动的封闭式吸气系统，旨在安全有效地吸引新生儿和儿童患者进行机械通气。Neo ET-Clear吸杆结合了可控的温和振动和内部冲洗，有助于粘液的清除。支架被插入和退出患者的ETT-类似于标准的封闭式吸引导管。第一阶段项目达到了所有特定目标，表明Neo ET-Clear在2.5 mm ETT的闭式吸痰过程中显著降低了对测试模型肺力学的影响(灵感潮气量的维持能力提高了2-3倍，PEEP损失仅为10%)，同时实现了与标准5Fr封闭式吸管相同的粘液清除和潮气量恢复。执业的NICU临床医生的反馈非常热情。第二阶段-假设：NEO ET-Clear用于新生儿患者是安全的，并减少了吸引术对血氧、肺力学和患者痛苦的负面影响。目标1-将设计和安全功能纳入并验证Neo ET-Clear不会影响有益的吸液效率结果。目标2-通过临床前测试证明Neo ET-Clear的安全性和改善的生理结果。AIM 3-Pilot Human临床评估(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).