Efficacy and Safety of Using Non-invasive Ventilation Assisted Fiber-optic Bronchoscopy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Evaluation of the changes in oxygen saturation, heart rate, respiratory rate, blood pressure, dyspnea score and arterial blood gases in bronchoscopy procedure
研究概览
简要总结
The purpose of this study is the evaluation of using bi-level positive airway pressure ventilation in candidates for fiber-optic bronchoscopy regarding benefits and drawbacks.
详细描述
In this study patients who will be candidate for fiber-optic bronchoscopy for diagnostic or therapeutic reasons will be evaluated by the Chest Medicine Department, Mansoura University Hospitals. All patients will be subjected to full history taking, full examination, routine laboratory investigations, arterial blood gases (ABG), chest X-ray, chest computed tomography (CT). Non-invasive ventilation: Group 1 (hypoexemic patient who will undergo bronchoscopy under non- invasive ventilation{NIV}) will be on NIV half an hour prior and throughout the bronchoscopic sampling and after the procedure until reach the baseline criteria, Group 2 (hypoxemic patients who will undergo conventional bronchoscopy ) will be on conventional oxygen therapy half an hour prior and throughout the bronchoscopic sampling and after the procedure until reach the baseline criteria, Group 3 (non- hypoxemic patients who will undergo conventional bronchoscopy ) will be on NIV throughout the bronchoscopic sampling and after the procedure until reach the baseline criteria, Group 4 (non- hypoxemic patients who will undergo conventional bronchoscopy) will be on conventional oxygen therapy throughout the bronchoscopic sampling and after the procedure until reach the baseline criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
Sample method:
Method of randomization was stratified random sampling method was adopted to create matched study groups. Patients admitted for bronchoscopy were classified into two categories:
- A) Non hypoxemic group.
- B) Hypoxemic group.
- From each category: 50 patients were selected and allocated randomly in the study groups (either intervention or control group) using lottery method. So, each study group with included 25 patients from each category forming a total of 50 patients in each studies categories.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who admitted to the pulmonology ward or intensive care unit with any (diagnostic and/or therapeutic) bronchoscopy indication.
- •Age 18 years or more.
- •Patients accepted to participate in the study.
排除标准
- •Patients with:
- •Cardiac or respiratory arrest.
- •Impaired consciousness or confusion.
- •Type II respiratory failure.
- •Hemodynamic instability.
- •Inability to cooperate or to protect the airway.
- •Vomiting, bowel obstruction, recent upper gastrointestinal tract surgery and esophageal injury.
- •Patients refusing participation in the study.
- •Patients unfit for NIV and or NIV mask.
- •Intubation and or invasive ventilation candidates.
- •Presence of contraindications for bronchoscopy procedure such as insufficient platelet number or coagulopathy.
结局指标
主要结局
Evaluation of the changes in oxygen saturation, heart rate, respiratory rate, blood pressure, dyspnea score and arterial blood gases in bronchoscopy procedure
时间窗: 4 years
Evaluate changes and when to reach base line in each of 1- (SPO2) by pulse oximeter in (percentage %) at base line, 15 minute before, during and immediately after bronchoscopy. 2-heart rate in (beat/minute) at base line, 15 minute before, during and immediately after bronchoscopy. 3-respiratory rate in (cycle/minute) at base line, 15 minute before, during and immediately after bronchoscopy. 4-mean arterial blood pressure in {millimeter/mercury mm/Hg)} at base line, 15 minute before, during and immediately after bronchoscopy. 5-dyspnea score in {grade 0-3 according to: (mMRC)} 15 minute before and immediately after bronchoscopy. arterial blood gases (PH, Paco2 in {millimeter/mercury (mm/Hg)}, Pao2 in {millimeter/mercury (mm/Hg)},Spo2 (percentage %) andHco3 in {millimol (mmol/l)} before and after bronchoscopy. To show effects of using NIV and conventional o2 therapy and using of conventional o2 therapy alone on these parameters in the studied patients in bronchoscopy.
次要结局
- Fiber-optic bronchoscopy complications(4 years)
研究者
Walaa Maher Abd El aziz
Principal Investigator Walaa Maher abd El aziz, Head of NIV Ahmed Younis El-sayed, Clinical Professor Amr Abd El-Hamid Moawad and Director Mohamed Ahmed Mansour Affiliation: Mansoura University
Mansoura University