Microbiote's Evolution After Use of Nitrous Oxide on Pediatric Patient Needing Airway Samples

Not Applicable

Not yet recruiting

• Conditions: Respiratory Ilness; Children
• Interventions: Drug: MEOPA; Other: Standard induced sputum

• Registration Number: NCT07118644
• Lead Sponsor: University Hospital, Brest

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2025-07-04
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-11
• Last Update Submitted: 2025-08-11
• Study First Posted: 2025-08-12
• Last Update Posted: 2025-08-12
• Study Start: 2025-09-01
• Primary Completion: 2027-09-06
• Study Completion: 2027-09-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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.

Exclusion Criteria

1. 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

2. 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.

3. Patient with minor parent(s)

4. Uncooperative child

5. Antibiotic therapy administered within the previous 24 hours.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Case	MEOPA	Induced sputum with MEOPA
Control	Standard induced sputum	Standard induced sputum

Primary Outcome Measures

Name	Time	Method
α and β diversities	Day 1	These outcomes will be calculated from ASV table obtained from 16S metagenomic analysis.

Secondary Outcome Measures

Name	Time	Method
Feeling of physiotherapist about the child's behaviour	Day 1	Likert scale after each induced sputum
Specimen quality	Day 1	Murray and Washington cytological score (good quality specimen: score ≥ 3; poor quality specimen: score \< 3)
Children anxiety	Day 1	mYPAS-SF (Modified Yale Preoperative Anxiety Scale, short version) total score before and after each induced sputum. Score between 4 and 18 (18 is the maximum level of anxiety)
Sputum induced adverse events	Day 5	Number of adverse events related to induced expectoration
Feeling of parent(s) about the child's behaviour	Day 1	Visual Analogue Scale (VAS) after each induced sputum
Adverse Events	Day 5	Number of adverse events
Search for microbiota mismatch with or without meopa	Day 1	The criterion is defined by an expert opinion indicating whether the results of the examinations are concordant, or discordant against MEOPA or discordant in favor of MEOPA
Bacterial taxa	Day 1	Bacterial taxa is identified by 16S v3-v4 targeted metagenomics.

Trial Locations

Locations (1)

Brest, University Hospital; 🇫🇷 Brest, France