Microbiote's Evolution After Use of Nitrous Oxide on Pediatric Patient Needing Airway Samples
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- α and β diversities
研究概览
简要总结
The objective of this study is to determine whether the use of MEOPA alters the composition of respiratory microbiota collected by induced sputum in children requiring respiratory sampling for suspected lower respiratory tract infection.
Children aged 3 months to 8 years and they requiring ECBC sampling in routine practice.
详细描述
This is an exploratory, controlled, open-label, prospective, monocentric clinicobiological case control study. Each case is its own control. A sample will be taken without MEOPA and then with MEOPA.
The Infants will be included after written informed consent will be obtained from the patients' parents or legally authorized representatives. Cytological and microbiological analyses are carried out on each sample.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged from 3 months to 8 years old
- •Patients requiring ECBC in routine practice: acute respiratory distress with suspected bacterial respiratory infection (superinfected bronchiolitis or asthma attack, suspected pneumonia) and severe asthma assessment
- •Child unable to expectorate effectively
- •Free, informed and written consent of the minor patient's legal guardians;
- •Enrolled in the social security system.
排除标准
- •Contraindication of MEOPA :
- •Patients requiring 100% oxygen ventilation
- •Intracranial hypertension
- •Altered state of consciousness preventing cooperation
- •Any condition where air is trapped inside the body and expansion could be dangerous (cranial and/or maxillofacial trauma, pneumothorax, emphysema, gas embolism, following recent scuba diving, decompression sickness following gas encephalography, during middle ear/internal ear or sinus surgery, abdominal gas distension, when air is injected into the epidural space during epidural anesthesia, if the patient has received ophthalmic gas (SF6, C3F8, C2F6) used in eye surgery for as long as the gas bubble persists and up to 3 months afterwards)
- •Known, unsubstituted vitamin B12 or folic acid deficiency
- •Recent, unexplained neurological abnormalities
- •Contraindications to induced expectoration :
- •Clinical instability not conducive to induced expectoration (at practitioner's discretion)
- •Severe respiratory insufficiency,
- •Severe spasticity.
- •Hemoptysis
- •Decompensated heart failure
- •Contraindication of hypertonic saline :
- •Hypersensitivity of the bronchial system to hypertonic sodium chloride solutions.
- •Hemoptysis
- •Contraindication to the use of Salbutamol :
- •Hypersensitivity to any of the constituents of salbutamol-based pressurized or inhaled products.
- •Intolerance to salbutamol-based pressurized or inhaled products (coughing or bronchospasm occurring immediately after inhalation of the product).
- •Contraindication of the maneuver performed by the physiotherapist: bullous emphysema, confirmed hiatal or diaphragmatic hernia and rib fragility.
- •Patient with minor parent(s)
- •Uncooperative child
- •Antibiotic therapy administered within the previous 24 hours.
研究组 & 干预措施
Case
Induced sputum with MEOPA
干预措施: MEOPA (Drug)
Control
Standard induced sputum
干预措施: Standard induced sputum (Other)
结局指标
主要结局
α and β diversities
时间窗: Day 1
These outcomes will be calculated from ASV table obtained from 16S metagenomic analysis.
次要结局
- Feeling of physiotherapist about the child's behaviour(Day 1)
- Specimen quality(Day 1)
- Children anxiety(Day 1)
- Sputum induced adverse events(Day 5)
- Feeling of parent(s) about the child's behaviour(Day 1)
- Adverse Events(Day 5)
- Search for microbiota mismatch with or without meopa(Day 1)
- Bacterial taxa(Day 1)