Patients Comfort During Highflow Oxygen Therapy With Asymmetrical Prongs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- COMFORT
研究概览
简要总结
High-flow nasal cannula (HFNC) is a respiratory support device widely used to manage acute respiratory failure (ARF) and recommended in different patient populations according to the last European Respiratory Society and European Society of Intensive Care Medicine guidelines. HFNC delivers heated and humidified oxygen that facilitates airway secretion clearance, and its use is associated with improvement of oxygenation and reduction of airway dead space compared to standard oxygen therapy. Finally, all these beneficial effects result in a greater comfort experienced by the patient, as compared either to standard oxygen therapy or non-invasive ventilation.
详细描述
Recently, a new HFNC interface using asymmetrical prongs (Optiflow® Duet system, Fisher & Paykel Healthcare, Auckland, New Zealand) was approved for clinical practice. Unlike nasal cannulas with equally sized prongs, asymmetrical prongs deliver different flow rates between the two nostrils. Bench studies have demonstrated that the asymmetrical configuration resulted in higher positive end-expiratory pressure (PEEP) and accelerated clearance of the anatomical dead space.
In a recent physiological cross-over study, randomizing 20 intensive care unit (ICU) patients with post-extubation hypoxemic ARF to the asymmetrical or symmetrical interface, the use of asymmetrical HFNCs, despite showing similar performances in terms of lung aeration, ventilatory efficiency, gas exchange, and inspiratory effort, was associated with improved patient comfort, compared to standard HFNC interface. However, the study population included mostly patients with moderate hypoxemic ARF and near-normal respiratory rate, while only few patients suffered severe hypoxemia or tachypnea.
Since patient comfort represents a major determinant for the success of a non-invasive respiratory support, especially when patient tolerance and compliance are challenged by the extended length of the treatment, we set up the present pilot study aiming at assessing patient comfort during oxygen support with asymmetrical HFNCs, comparing two cannula sizes, one completely occluding the nostril and one a size smaller.
Secondary outcome variables include patient dyspnea, lung aeration, as assessed with electrical impedance tomography (EIT), ventilatory efficiency, and gas exchange.
Measurements During HFNC support, the FiO2 will be titrated to maintain a peripheral oxygen saturation between 90% and 94%, the gas flow rate will be set at 50-60 L/min, and the temperature of the heated humidifier (Fisher&Paykel Healthcare, New Zealand) will be set at 37° C (absolute humidity delivered 44 mgH2O/L) for the entire study period.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
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
- •adult patients (>18 years old) requiring oxygen support in the ICU
排除标准
- •pregnancy;
- •presence of tracheostomy;
- •contraindications to EIT;
- •contraindications to HFNCs positioning,
- •clinical evidence of nare occlusion (patient will be asked to deeply inspire from the nose while researcher occludes manually each nostril alternately: if unable to breath from the free nare with the other one occluded, patient will not be eligible for participating to the study), or very small nare fitting only the S-sized Duet cannulas;
- •patients requiring nasogastric tubes for mandatory clinical reasons, i.e., delayed gastric emptying, upper abdominal surgery.
结局指标
主要结局
COMFORT
时间窗: After 60 minutes of HFNC support
The present pilot study aims at assessing patient comfort during oxygen support with asymmetrical HFNCs, comparing two cannula sizes, one completely occluding the nostril and one a size smaller. The evaluation scale is the 0-10 numeric rating scale (NRS). Each step will be 60 min long and a 10-min 'wash-out' phase with Venturi mask support will be required before each step.
次要结局
- DYSPNEA(After 60 minutes of HFNC support)
- LUNG AERATION(After 60 minutes of HFNC support)
- Respiratory rate, peripheral oxygen saturation, gas-changes, ratio between PaO2 and inspiratory oxygen fraction, ventilatory ratio [10](After 60 minutes of HFNC support)
研究者
Annalisa Boscolo
Professor
University of Padova