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临床试验/NCT02167542
NCT02167542已完成不适用

Positive Pressure During Bronchoscopy: Noninvasive Positive Pressure Ventilation vs Continuous Positive Airway Pressure Valve

Hospital Sao Joao2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2010年2月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
Change in arterial parcial oxygen pressure / Inspired oxygen fraction ratio (PaO2/FiO2)

研究概览

简要总结

It has been demonstrated the application of noninvasive positive pressure ventilation (NPPV) to assist spontaneous breathing through a face mask during fiberoptic bronchoscopy (FOB) with bronchoalveolar lavage (BAL) in severely hypoxemic, nonintubated patients. With NPPV, FOB was well-tolerated, significantly improved the PaO2/FiO2 ratio, and successfully avoided the need for endotracheal intubation. Two randomized studies have provided supporting evidence that the application of NPPV or CPAP via a face mask was superior to oxygen supplementation alone during FOB.

For this reason patients who require FOB and are hypoxemic and/or mild hypercapnic (TcCO2 < 60mmHg) will be compared in a randomized study by comparing NPPV vs CPAP Boussignac (Vygon) delivered through a face mask.

详细描述

Since its introduction in the late 1960s, fiberoptic bronchoscopy (FOB) has been increasingly used for diagnostic and therapeutic purposes. Because arterial oxygen tension (PaO2) usually decreases by 10 to 20 mm Hg after uncomplicated bronchoscopy, severe hypoxemia in nonintubated patients is an accepted contraindication to bronchoscopy. The American Thoracic Society recommends avoiding bronchoalveolar lavage (BAL) in spontaneously breathing patients with hypercapnia or hypoxemia that cannot be corrected to at least a PaO2 of 75 mm Hg or to oxygen saturation greater than 90% with supplemental oxygen (1). In these high-risk patients, the options are to intubate and to apply mechanical ventilation (MV) to ensure adequate gas exchange during FOB or to avoid FOB and to institute empirical treatment.

This limitation has prompted the development of techniques of respiratory support to make the FOB procedure safer for hypoxemic or critically ill patients, without using invasive ventilation.

It has been demonstrated the application of noninvasive positive pressure ventilation (NPPV) to assist spontaneous breathing through a face mask during FOB with BAL in severely hypoxemic, nonintubated patients (2). FOB was well-tolerated, significantly improved the PaO2/FiO2 ratio, and successfully avoided the need for endotracheal intubation. Two randomized studies have provided supporting evidence that the application of NPPV or CPAP via a face mask was superior to oxygen supplementation alone during FOB (3,4).

For this reason patients who require FOB and are hypoxemic and/or mild hypercapnic (TcCO2 < 60mmHg) will be compared in a randomized study by comparing NPPV vs CPAP Boussignac (Vygon) delivered through a face mask.

Methods Adult patients will be recuited in Bronchology Department and Intensive Care Units of the Hospital S. João, EPE. Only when inclusion criteria and a written informed consent of participation have been obtained from the patient, they will enter this study.

研究设计

研究类型
Interventional
分配方式
Randomized
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

入选标准

  • need for FOB;
  • hypoxemia, defined by pulse oximetry (SpO2) >92% under oxygen supplementation;
  • mild hypercapnia, defined by transcutaneous CO2 (PaCO2) <60mmHg;
  • already under domiciliary NPPV.

排除标准

  • emergent intubation;
  • recent (less than 1 wk) acute myocardial infarction;
  • ph bellow 7.30;
  • PaCo2 > 60mmHg;
  • systolic blood pressure < 80mmHg;
  • encephalopathy or coma.

研究组 & 干预措施

NPPV group

Experimental

Patients assigned to noninvasive positive pressure ventilation (NPPV) are connected to the ventilator through a face mask (VBM Endoscopy Mask) that is secured to the patient's face by the investigator.

干预措施: Noninvasive Positive Pressure Ventilation (Device)

CPAP valve group

Active Comparator

Patients assigned to CPAP valve (Boussignac valve, Vygon, Inc) are connected to this device through a standard face mask that is secured to the patient's face with elastic straps.

干预措施: CPAP valve (Boussignac) (Device)

结局指标

主要结局

Change in arterial parcial oxygen pressure / Inspired oxygen fraction ratio (PaO2/FiO2)

时间窗: Before and 5 min after the exam (FOB)

次要结局

  • Electrocardiogram(up to 60 min after FOB)
  • Heart Rate(up to 60 min after FOB)
  • Respiratory Rate(up to 60 min after FOB)
  • Peripheal oxygen saturation(up to 60 min after FOB)

研究者

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

Miguel R. Goncalves

PhD

Hospital Sao Joao

研究点 (2)

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