Optimal Positive Airway Pressure in Overlap Syndrome: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 主要终点
- diurnal hypercapnia (pCO2 <= 45 mmH2O )
研究概览
简要总结
Continuous positive airway pressure (CPAP) became the established treatment for overlap syndrome (OS). It has been showed that the survival benefits of CPAP favored hypercapnic patients. When considering hypercapnic stable COPD patients, survival benefits occurred when the use of bi- level ventilation therapy was targeted to significantly reduce hypercapnia.
This highlights the relevance of hypercapnia and hypoventilation correction. Thus, the purpose of this study is to compare the use of CPAP to Bi-level ventilation in hypercapnic OS patients, since the later may correct not only the airway patency but also increase the magnitude of each breath.
详细描述
Obstructive sleep apnea syndrome (OSAS) and chronic obstructive pulmonary disease (COPD) represent two of the most prevalent respiratory disorders in clinical practice and their coexistence is often described has "overlap syndrome" (OS) In patients with COPD, the coexistence of OSA is associated with an increased risk of death from any cause, and hospitalization because of COPD exacerbation. Treatment with continuous positive airway pressure (CPAP) has been showed to be effective and associated with improved survival and decreased hospitalizations. When CPAP became established treatment for overlap syndrome, a multivariate analysis revealed that the hours of CPAP use were an independent predictor of mortality. Furthermore, it has been showed that the survival benefit of CPAP favors hypercapnic patients with overlap syndrome.
Regarding hypercapnic stable COPD patients, the best results with long-term non-invasive positive pressure ventilation have been noted in studies using more intensive strategies of ventilation, with higher inspiratory pressures and higher backup rates that improved or even normalized daytime hypercapnia. In fact, survival benefits occurred when ventilation was targeted to significantly reduce hypercapnia.
As for typical COPD, overlap syndrome patients might also benefit from optimal daytime hypercapnia correction, which could be better achieved using bi-level ventilation instead of CPAP, since it could not only maintain airway patency but also improve alveolar ventilation.
This study aims to compare CPAP therapy to bi-level ventilatory support in overlap syndrome patients, not only for the efficacy to achieve hypercapnia reduction, but also regarding acute disease exacerbations, symptoms and treatment compliance. Therefore, the authors designed a randomized controlled trial with recruitment and power calculations based on the applicant's own data.
After the diagnosis, patients will be randomized either for CPAP or BPAP treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COPD (FEV1/FVC < 70 (post-BD) and history of smoking - 10 PPY)
- •FEV1< 80% and COPD symptoms
- •AHI ≥ 15 events/hour
排除标准
- •Persistent hypercapnic respiratory failure with acidosis (defined as pH <7.30 after bronchodilators)
- •Hypoxia requiring long term oxygen therapy
- •BMI > 35 kg/m2
- •Previously-initiated long term non-invasive positive pressure ventilation
- •Other lung disease resulting in respiratory symptoms
- •Age <40 years
- •Pregnancy
- •Malignant comorbidities
- •Patients undergoing renal replacement therapy
- •Restrictive lung disease causing hypercapnia
- •Severe heart failure, unstable angina and severe arrhythmias
- •Inability to comply with the protocol
研究组 & 干预措施
CPAP
Oronasal CPAP therapy applied as per current international guidelines
干预措施: continuous positive airway pressure without ventilatory support (Device)
Bi-level
Oronasal Bi-level therapy + supplemental oxygen (if necessary) applied as per current international guidelines
干预措施: Bi-level positive airway pressure with ventilatory support (Device)
结局指标
主要结局
diurnal hypercapnia (pCO2 <= 45 mmH2O )
时间窗: 1 year
(PaCO2 \<= 45 mmH2O )
nocturnal oxygen desaturation correction
时间窗: 1 year
Mean nocturnal SpO2 \>=90%, with \<10% of the total recording time \<90% after correction of leaks)
次要结局
- Changes in FEV1(1 year)
- Changes in FVC(1 year)
- Changes in RV(1 year)
- exercise tolerance(1 year)
- Sleepiness evaluation(1 year)
- acute respiratory exacerbations(1 year)
- Compliance to PAP(1 year)
- PAP usage(1 year)
- Dyspnoea evaluation(1 year)
- Symptoms of COPD(1 year)
- Apneia/Hiponeia Index(1 year)
- nocturnal hypoventilation(1 year)
研究者
Miguel R. Goncalves
Clinical Professor
Hospital Sao Joao