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临床试验/NCT04728412
NCT04728412尚未招募不适用

High Flow Oxygen Therapy in Patients With or at Risk of Respiratory Failure Undergoing Felxible Bronchoscopy Under Sedation: a Pilot Study

Cardarelli Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
2
主要终点
Percent of variation of PaCO2 variation, comparing ABG performed before bronchoscopy with that performed before partecipant's transferral to recovery room.

研究概览

简要总结

A reduction of peripheral oxygen saturation (SpO2) commonly occurs during bronchoscopy and may be associated with both respiratory and cardiac adverse events. The type of breathing assistance that should be delivered to patients, in order to treat and/or to prevent acute respiratory failure, during or after bronchoscopy, is not universally standardized; studies comparing the impact of different respiratory supports on patient's outcome and on hospital resource use are very few. the risk of respiratory failure rises according to the type of procedure (i.e., increased risk with broncho-alveolar lavage and trans-bronchial lung biopsy) and to the use of sedative drugs. Conventional oxygen therapy with nasal cannula, continuous positive airway pressure and non-invasive ventilation are commonly applied during endoscopic procedures. High flow oxygen therapy (HFOT) is a relatively novel device, still under-used in the context of interventional pulmonology, providing an humidified air-oxygen blend up to 60 L/min. HFOT has been reported to be effective for the treatment of both hypoxemic and hypercapnic respiratory failure. The investigators hypothesize that HFOT could be feasible and safe in patients undergoing bronchoscopy under moderate sedation, affected by or at risk of hypoxemic and/or hypercapnic respiratory failure.

研究设计

研究类型
Interventional
分配方式
Na
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

  • pH ≥7.30 e PaCO2 >45 mmHg and/or
  • PaO2/FiO2 <300 mmHg o SpO2 <90 percent on room air
  • Patient at risk of respiratory failure (COPD III-IV GOLD stage; OSAS; restrictive lung and chest wall diseases; cardiac failure)

排除标准

  • Need of laryngeal mask and/or
  • Patients on NIV for >16 hrs/day and/or
  • pH <7.30 and/or
  • Tracheostomy and/or
  • Recent (<3 months) facial trauma and/or
  • Hemodynamic instability and/or
  • High risk of aspiration and/or
  • Lacerated trachea

结局指标

主要结局

Percent of variation of PaCO2 variation, comparing ABG performed before bronchoscopy with that performed before partecipant's transferral to recovery room.

时间窗: one year

Rate of new appearance of hemodynamic instability.

时间窗: one year

Number of desaturation, defined as SpO2< 90 percent percent for >1 min, <5.

时间窗: one year

Percent of variation of pH, comparing ABG performed before bronchoscopy with that performed before partecipant's transferral to recovery room.

时间窗: one year

Rate of interruption of bronchoscopy because of number of desaturation, defined as SpO2< 90 percent for >1 min, >5.

时间窗: one year

Number of partecipants requiring an escalation of respiratory support.

时间窗: one year

次要结局

  • Rate of change of HFOT parameters because of desaturation without respiratory acidosis.(one year)
  • Lowest oxygen saturation under HFOT.(one year)
  • value of Charlson Comobidity Index associated with HFOT failure.(one year)
  • Number of desaturations, defined as SpO2< 90 percent for >1 min.(one year)
  • Rate of change of HFOT parameters because of desaturation with respiratory acidosis(one year)
  • value of Body Mass Index associated with HFOT failure.(one year)
  • value of Borg dyspnea scale associated with HFOT failure.(one year)

研究者

发起方
Cardarelli Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Giuseppe Failla

Chief of Interventional Pulmonology Unit

Cardarelli Hospital

研究点 (2)

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