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临床试验/NCT05190458
NCT05190458Unknown不适用

Evaluation of High Velocity Nasal Insufflation in Management of Respiratory Failure in Patients With Overlap Syndrome.

Assiut University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
2
主要终点
Evaluation of HVNI in correction of Hypercapnia.

研究概览

简要总结

High velocity nasal insufflation (HVNI), a form of HFNC that utilizes a small bore nasal cannula to generate higher velocities of gas delivery than HFNC which uses large bore cannula, has the ability to accomplish complete purge of extra thoracic dead space at flow rates of 35 litres/min and may be able to provide ventilatory support in patients with respiratory failure in addition to oxygenation support in patients with overlap syndrome.

This study aims to evaluate the effectiveness of HVNI compared to NIMV in management of respiratory failure in patients with obesity hypoventilation syndrome and overlap syndrome.

详细描述

Overlap syndrome (OVS) is the concurrence of chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA), and is associated with poor outcomes.

COPD and obstructive sleep apnoea (OSA) are highly prevalent and different clinical COPD phenotypes that influence the likelihood of comorbid OSA.

The increased lung volumes and low body mass index (BMI) associated with the predominant emphysema phenotype protects against OSA whereas the peripheral oedema and higher BMI often associated with the predominant chronic bronchitis phenotype promote OSA.

The diagnosis of OSA in COPD patients requires clinical awareness and screening questionnaires which may help identify patients for overnight study.

Management of OSA-COPD overlap patients differs from COPD alone and the survival of overlap patients treated with nocturnal positive airway pressure is superior to those untreated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
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

  • Patients with respiratory failure in obesity hypoventilation syndrome and overlap syndrome, requiring ICU admission and fulfill criteria of NIMV supplementation (GOLD criteria 2021)
  • patients with obesity hypoventilation syndrome and overlap syndrome diagnosed by polysomnogram or through STOP BANG Questionnaire or EPWORTH Sleepness Scale.

排除标准

  • Patients less than 18 years old
  • Patients with hemodynamic instability
  • Patients with central causes of hypercapnic respiratory failure
  • Patients with disturbed conscious level
  • Patients who refuse to participate in the study

结局指标

主要结局

Evaluation of HVNI in correction of Hypercapnia.

时间窗: Baseline

Evaluation of the effectiveness of HVNI in correction of Hypercapnia through measurement of PCO2 by mmHg via arterial blood gases test (ABG)

Evaluation of HVNI in correction of Acidosis .

时间窗: Baseline

Evaluation of the effectiveness of HVNI in correction of Acidosis through measurement of PH via arterial blood gases test (ABG).

次要结局

  • Evaluation of HVNI in management of respiratory failure.(Baseline)

研究者

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

Abanoub Hany Sadek Farag

Resident Doctor at chest department-Assiut University Hospitals

Assiut University

研究点 (2)

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