2024-518197-14-00招募中2 期
Lung Microbiota’s evolution after use of Nitrous Oxide on pediatric patient needing airway samples - MicroNO
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pulmonary bacterial biodiversity assessed using quantitative indices such as alpha diversity and beta diversity calculated for good-quality respiratory samples
研究概览
简要总结
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.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Children aged 3 months to 8 years
- •Patients requiring ECBC sampling in routine practice: acute respiratory distress with suspected lower respiratory infection (superinfected bronchiolitis or asthma attacks, suspected pneumonitis) and severe asthma
- •Free, informed and written consent from at least one of the minor's legal representatives
- •Affiliated to the social security system
- •Child unable to expectorate effectively
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 trapped́ inside the body and its expansion could be dangerous (cranial and/or maxillofacial trauma, pneumothorax, emphysema, gas embolism, following recent scuba diving, decompression accident, during middle ear/internal ear or sinus surgery, abdominal gas distension, if air is injected into the epidural space during epidural anesthesia, if the patient has received ophthalmic gas for as long as the gas bubble persists and up to 3 months afterwards) - Known, unsubstituted vitamin B12 or folic acid deficiency - Recent onset of unexplained neurological abnormalities.
- •Contraindications for induced expectoration: Clinical instability not conducive to induced expectoration (at practitioner's discretion) - Severe respiratory insufficiency, - Severe spasticity. - Hemoptysis - Decompensated heart failure - Contraindications to the use of hypertonic saline : o Hypersensitivity of the bronchial system to hypertonic sodium chloride solutions. o Hemoptysis. - Contraindication to the use of salbutamol o 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 to maneuvers performed by physiotherapists: bullous emphysema, confirmed hiatal or diaphragmatic hernia and rib fragility.
- •Patient with minor parent(s)
- •Antibiotic therapy administered within the previous 24 hours.
- •Uncooperative child
结局指标
主要结局
Pulmonary bacterial biodiversity assessed using quantitative indices such as alpha diversity and beta diversity calculated for good-quality respiratory samples
Pulmonary bacterial biodiversity assessed using quantitative indices such as alpha diversity and beta diversity calculated for good-quality respiratory samples
次要结局
- Assessment of sputum tolerance induced by -The use of age-appropriate anxiety scores (mYPAS-SF, cf. appendix 2) -Likert scales to assess the MKDE practitioner's feelings (cf. Appendix 3) -A numerical scale from 0 to 10 to assess the parents' feelings
- Quality of samples according to cytological score
- Collection of adverse events
- Difference between ECBC with and without MEOPA (direct examination, count and culture)
- Catalog of bacterial taxa identified by 16S v3-v4 targeted metagenomics.
研究者
Dr Pierrick CROS
Scientific
Centre Hospitalier Regional Et Universitaire De Brest
研究点 (1)
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