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临床试验/NCT06442163
NCT06442163已完成不适用

Outcome Measures of Auto-titrating Average Volume-assured Pressure Support (AVAPS) as Rescue Therapy After CPAP Titration Failure in Patients With Obesity Hypoventilation Syndrome: Adherence and Sleep Quality

Assiut University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年5月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
To compare the initial diagnostic, and therapeutic sleep study parameters using either CPAP and (AVAPS-AE) titration study in patients with OHS.

研究概览

简要总结

It remains unclear whether CPAP therapy should be prescribed if significant hypoxemia persists during CPAP titration, despite optimization of upper airway obstructive events, if maximum CPAP pressure is reached.

The goal was to examine the effects of 6 months of home AVAPS therapy in patients with obesity hypoventilation syndrome as a potential option for patients who failed CPAP titration due to persistent hypoxemia.

详细描述

Obesity hypoventilation syndrome (OHS) is one of the leading indications of home non-invasive ventilation (NIV) initiation. In patients with OHS, NIV improves daytime vigilance, decreases PaCO2, improves sleep quality, and improves physical activity.

Thus, the primary aim of this study was to evaluate the effects of 6-month noninvasive ventilation with average volume-assured pressure support (AVAPS-AE) ventilation on objective sleep quality and adherence to therapy in stable patients with OHS who failed CPAP titration.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
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

入选标准

  • All Clinically stable OHS patients with
  • Body mass index of 30 kg/m2 ,
  • Daytime hypercapnia (PaCO2 >45 mm Hg) who had failed to respond to CPAP therapy
  • had no other cause for their chronic respiratory failure and were naive to any PAP therapy.

排除标准

  • Patients with evidence of acute respiratory failure (patients with worsening symptoms during the last 2 weeks before the screening visit, a breathing frequency of 30 breaths/ minute, or signs of respiratory infections)
  • Patients who had been intubated during the last 3 months
  • Patients who had received any other form of ventilatory support before hospital admission were also excluded from the study

结局指标

主要结局

To compare the initial diagnostic, and therapeutic sleep study parameters using either CPAP and (AVAPS-AE) titration study in patients with OHS.

时间窗: 1 week

polysomnographic parameter (apnea hypopnea index (events/hours)

次要结局

  • The effects of 6 month of home AVAPS- AE therapy on patient adherence and sleep quality in OHS patients who failed CPAP titration due to persistent hypoxemia.(at 1 ,3,6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Doaa Magdy Eid

professor of pulmonary medecine

Assiut University

研究点 (2)

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