Nitrous oxide; Oxygen for Pediatric respiratory disorder

Inclusion criteria

• {"criterion_text":"- Children aged 3 months to 8 years\n- 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\n- Free, informed and written consent from at least one of the minor's legal representatives\n- Affiliated to the social security system\n- Child unable to expectorate effectively"}

Exclusion criteria

• {"criterion_text":"- 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.\n- 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.\n- Patient with minor parent(s)\n- Antibiotic therapy administered within the previous 24 hours.\n- Uncooperative child"}

Primary endpoints

• {"endpoint_text":"- Pulmonary bacterial biodiversity assessed using quantitative indices such as alpha diversity and beta diversity calculated for good-quality respiratory samples","definition_or_measurement_approach":"Assessed using quantitative indices such as alpha diversity and beta diversity calculated for good-quality respiratory samples."}

Secondary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Measured by age-appropriate anxiety scores (mYPAS-SF), Likert scales for MKDE practitioner feelings, and a numerical scale (0-10) for parents' feelings."}
• {"endpoint_text":"- Quality of samples according to cytological score","definition_or_measurement_approach":"Quality assessed using a cytological score."}
• {"endpoint_text":"- Collection of adverse events","definition_or_measurement_approach":"Adverse events collected and recorded (no further detail provided)."}
• {"endpoint_text":"- Difference between ECBC with and without MEOPA (direct examination, count and culture)","definition_or_measurement_approach":"Comparison via direct examination, quantitative counts and culture results between ECBC samples obtained with and without MEOPA."}
• {"endpoint_text":"- Catalog of bacterial taxa identified by 16S v3-v4 targeted metagenomics.","definition_or_measurement_approach":"Identification of bacterial taxa using targeted 16S v3-v4 metagenomic sequencing."}

France

Earliest CTIS Part Ii Submission Date

13-01-2025

Latest Decision Or Authorization Date

26-08-2025

Processing Time Days

225

Number Of Sites

1

Number Of Participants

40

Primary sponsor

Full Name

Centre Hospitalier Regional Et Universitaire De Brest

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France