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临床试验/NCT06285994
NCT06285994已完成不适用

Complications of High Frequency Jet Ventilation During Bronchoscopy - a Retrospective Cohort Study

Erasme University Hospital1 个研究点 分布在 1 个国家目标入组 1,385 人开始时间: 2024年3月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,385
试验地点
1
主要终点
Occurence of complications

研究概览

简要总结

High frequency jet ventilation (HFJV) has been introduced in 1967 as technique allowing ventilation with simultaneous access to the airway for bronchoscopy. Continuous improvement in the technique has led to a large use during interventional bronchoscopy, especially in large centers. However, complications occuring during the use of HFJV are poorly known. In this retrospective cohort study, the charts of all patients who had a bronchoscopy with the use of HFJV between 2019 and 2023 in our hospital will be analyzed. Primary outcome will the description of all complications during HFJV. Complications are defined as:

  • Hypoxia: SpO2 < 90% for 1 min
  • Severe hypoxia: SpO2 < 85% for 1 min
  • Hemodynamic instability, defined as Arterial pressure < 90/60
  • Cardiac arrhythmia
  • Laryngospasm or bronchospasm
  • Barotrauma or volutrauma
  • Need for ICU admission

A model predicting the risk for developing any complication will be developped using 2 mathematical methods:

  • a multivariate analysis
  • a data mining approach

For both approaches, the following variables will be included in the model:

  • Age

  • Gender

  • Weight

  • Height

  • BMI

  • Smoking

  • Alcohol consumption

  • Consumption of Other drugs

  • ASA class

  • Obstructive pulmonary disease

  • Restrictive lung disease

  • COPD status (1, 2, 3, 4)

  • Interstitial lung disease

  • Lung tumor

  • Trachea location

  • Carina location

  • Bronchial location

  • Pulmonary or tracheal stenosis

  • Presence of stridor

  • Severe stenosis (< 6 mm)

  • Baseline SpO2 (pre-intervention)

  • Pre-intervention oxygen requirement Procedure

  • Duration (min)

  • Stent placement

  • Dilation

  • Laser treatment

  • Length of hospital stay Lung function tests

  • FEV1 (forced expiratory volume)

  • VC (Vital Capacity)

  • FEV1/VC (Tiffeneau ratio)

  • CPT (total lung capacity)

  • DLCO (carbon monoxide diffusion)

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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 patients who underwent a bronchoscopy with the use of high frequency jet ventilation between January 1st, 2019 and December 31st, 2023 at Erasme University Hospital, Brussels

排除标准

  • Incomplete medical chart
  • Patient who expressed their opposition to the use of their medical data

结局指标

主要结局

Occurence of complications

时间窗: 6 hours

The occurence (%) of complications of HFJV will be analyzed. Definition of complications is one or more of the following events: * Hypoxia: SpO2 \< 90% for 1 min (%) * Severe hypoxia: SpO2 \< 85% for 1 min (%) * Hemodynamic instability, defined as Arterial pressure \< 90/60 (%) * Cardiac arrhythmia (%) * Laryngospasm or bronchospasm (%) * Barotrauma or volutrauma (%) * Need for ICU admission (%) Complications will be reported as overall complications (%) defined as the occurence of one or more of the listed events. Frequency of single events will be reported separately (%). Descriptive statistics ( %, mean, standard deviation, median, interquartile range) will be used as appropriate.

次要结局

  • Prediction model of complications(6 hours)

研究者

发起方
Erasme University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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