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临床试验/NCT05655026
NCT05655026Unknown不适用

The Use of Non-invasive Respiratory Assistance to Facilitate Bronchofiberoscopy Performance in Patients With Hypoxemic (Type One) Respiratory Failure

Medical University of Silesia1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
1
主要终点
Hypoxemia

研究概览

简要总结

The aim of the study is to asses safety and indications and contraindications for performing bronchofiberocopy (FB) with respiratory support methods, i.e. non-invasive ventilation (NIV) and high flow nasal oxygen therapy (HFNO). Additionally, researchers want to determine how using these methods could avoid the risk of most common complications such as: hypoxemia-related events, decompensation of chronic respiratory failure, worsening of gas exchange, hemodynamic instability.

详细描述

Bronchofiberoscopy (FOB) is a minimally invasive procedure that has been commonly performed for many years in pneumological patients and in patients requiring intensive medical care.inistered to let patients tolerate FOB is an additional factor for derangement of blood gases. FB is usually performed with oxygen supplementation administered through standard nasal cannula. Due to increasing number of seriously ill, patient with respiratory failure, pure oxygen support is frequently insufficient to assure accurate oxygenation and prevent hypercapnia in patients requiring FOB. Up till now, many of those patients have been disqualified or intubated from FOB due to unfavorable risk to benefits balance.

NIV assures normal minute ventilation in patients with decreased respiratory drive, prevents collapsing of the peripheral airways, prevents atelectasis development, facilitates alveoli recruitment, increases vital capacity and lung susceptibility, as well as decrease heart workload. NIV may enable therapeutic FOB performance in patients with alveolar proteinosis without the need for intubation. NIV allows to perform safe bronchofiberoscopy in both diagnostic and therapeutic indications in patients with exacerbation of respiratory failure as well as in patients with severe chronic respiratory failure.

HFNC is another innovative method of respiratory support, which generates turbulent flow in patient's nasopharyngeal cavity and facilitates precise settings of high oxygen concentrations FiO2 up to 1 (100%). Obtained high flow is associated with generation of positive airway pressure, which additionally recruits alveoli and reduces atelectasis, which is partially similar to NIV and may give additional benefits to treatment of respiratory failure. Preliminary data indicate that both of described methods have a potential role in increasing the safety of FOB examinations in patients with mild to moderate respiratory failure. However, as of today it has not been clearly supported by scientific evidence, whether there are differences in the indications, contraindications, complications risk. As so far there is lack of evidence which would clearly indicate the target population which would benefit mostly from NIV-FOB or HFNC-FOB.

Additionally, investigators do not currently know universal settings of both devices which could be used initially and universally during FOB in patients with different severity of respiratory failure. In patients with severe respiratory failure, in some cases it is compulsory to intubate patient in order to perform a safe bronchoscopy. In cases of patient who have not been intubated, FOB could cause exacerbation of underlying respiratory failure, which may require intubation and ICU transfer.

This is a multicenter international three-arm Randomized Controlled Trial (RCT) performed in departments which deal with patients suffering from respiratory failure: respiratory intensive care unit (RICU), bronchoscopic theatre- form patients treated in other departments such as internal medicine departments, cardiology etc, pulmonary ward and ICU departments in apriori not intubated patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

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

  • Patient ≥ 18 years, with indications for bronchoscopy,
  • Diagnostic procedure: lung cancer, hemoptysis, BAL in interstitial lung diseases.
  • Therapeutic procedure: pneumonia in patients with impaired cough reflex, performed to obtain sputum cultures and bronchial tree toilet, hemoptysis or foreign body aspiration in patients not requiring rigid bronchoscopic management.
  • Written informed consent to participate in the study,
  • PO2/fiO2≤300 in blood gas test performed directly (within 24 h) during the qualification for FB

排除标准

  • No willingness to participate,
  • PO2/fiO2>300 in arterial blood gases, severe unstable coronary artery disease (CCS III/IV), NYHA III/IV,
  • Hemodynamic instability defined as continuous amine influx. Myocardial infarction during the last 2 weeks, without PCI treatment. Unstable angina, severe arrhythmias - especially ventricular,
  • Chronic primary pulmonary hypertension confirmed by right heart catherisation in WHO III/IV,
  • Unsecured by chest tube pneumothorax,
  • Platelet count <20,000 /µl (without platelet transfusion),
  • INR >2 or APTT >36 s., in case of diagnostic FB [18]
  • The study will also not include patients who were intubated before randomization.

结局指标

主要结局

Hypoxemia

时间窗: 2 years

measure by pulsoxymetry, blood gas test. Number of Participants with procedure related complications

Comfort

时间窗: 2 years

Use dedicated questionaire to asses patient condition after bronchoskopy

Safety

时间窗: 2 years

Number of Participants with procedure related complications

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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