Evaluation of The MetaNeb® System to Reduce Atelectasis Assessed by Chest X-ray
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Chest X-ray Score at Day 2 (Approximately 48 Hours) After Initiation of Therapy With The MetaNeb® System.
研究概览
简要总结
To study objective is to evaluate the impact of use of The MetaNeb® System in clearance of atelectasis, as demonstrated by improvement in chest x-rays. This is a a non-randomized open label study, with all subjects receiving treatment with The MetaNeb® System. Subjects who qualify for enrollment in the study will receive therapy with The MetaNeb® System following the labeled instructions for the device. Details of the treatment including duration and frequency will be defined in treatment procedures.
详细描述
Study Population:
Post-surgical (thoracic, cardiac or abdominal surgery) non-mechanically ventilated patients with significant atelectasis as documented by chest x-ray results.
Duration of treatment:
Duration of treatment with The MetaNeb® System will be a minimum of 48 hours, or until the subject is discharged from the hospital (if discharge is earlier). Enrolled subjects will remain in the study through Day 4 or until the subject is discharged from the hospital, whichever occurs sooner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Post-surgical (thoracic, cardiac or abdominal surgery)
- •Age ≥ 18 years
- •Significant atelectasis by chest x-ray
- •Patient meets indication for therapy intervention as defined by Recruitment and Airway Clearance Protocol (Respiratory Department Policy and Procedure)
- •Signed informed consent
排除标准
- •Cause of atelectasis suspected to be infectious or solid mass
- •Requirement for mechanical ventilation
- •Requirement for chronic supplemental oxygen
- •Hemodynamically unstable, as defined by need for vasopressor therapy
- •Anticipated need for mechanical ventilation or other poor clinical outcome, unrelated to atelectasis or secretion retention
- •Contraindication to MetaNeb® therapy (untreated tension pneumothorax)
- •Inability to perform MetaNeb® therapy using a mouthpiece
- •Anticipated hospital discharge within 24 hours
结局指标
主要结局
Chest X-ray Score at Day 2 (Approximately 48 Hours) After Initiation of Therapy With The MetaNeb® System.
时间窗: Approximately 48 hours post-initiation of therapy with The MetaNeb® System.
Chest x-rays were scored using the Kelly scoring system to assess the presence of atelectasis on Day 2, after initiation of therapy with The MetaNeb® System. Scores for chest x-rays at Day 2 were compared to the scores for chest x-rays taken at baseline. 3 of the 8 subjects did not have measurable level of atelectasis at baseline and were excluded from the Kelly Score analyses. A score of 0 represents normal clear lungs whilst a score of 4 represent the whole lung is consolidated. A blinded reader scored each lung separately based on the Kelly Score scale. The Kelly scores from the left and right lung of each subject were averaged to get a mean score for each subject. Kelly Score ranges are as follows: 0 Normal; 1 Linear atelectasis; 1.25 a: one third of hemidiaphragm; 1.50b: two thirds of hemidiaphragm;1.75c: all of one hemidiaphragm; 2 Lobar consolidation; 3 Lobar collapse; 4 Bronchial consolidation (whole lung, bronchopneumonia etc.,)
次要结局
- Chest X-ray Assessed by Kelly Atelectasis Score at Day 1 (Approximately 24 Hours) and Day 4 (Approximately 96 Hours, or at Discharge if Discharge Occurs Before Day 4), Compared to Baseline.(Approximately 24 hours and at Day 4, approximately 96 hours, or at discharge if discharge occurs before Day 4)
- Chest X-ray Improvement Using a Comparative Scale (Comparing Baseline, Day 1, Day 2, and Day 4/Discharge).(Comparing baseline, Day 1, Day 2, and Day 4/discharge.)
- Oxygenation Index (SpO2 /FiO2 Ratio).(Oxygenation Index (SpO2 /FiO2 ratio) at Baseline, Day 1 AM, Day 1 PM, Day 2 AM, Day 2 PM, and Day 4/early discharge)
- Patient Reported Level of Dyspnea Assessed by Modified Borg Dyspnea Scale.(Patient reported level of dyspnea assessed by Modified Borg Dyspnea Scale on Baseline (Day 0), Day 1, and Day 2.)
- Change in Patient Respiratory Status Assessed by Subjective Physician Respiratory Status Evaluation.(Respiratory status evaluation at time of enrollment and on Day 2)