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

NCT ID: NCT07118644

Last Updated: 2025-08-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2027-09-06

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.

Conditions

Respiratory Ilness; Children

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Case

Induced sputum with MEOPA

Group Type: EXPERIMENTAL

MEOPA

Intervention Type: DRUG

Induced sputum with be performed by trained physiotherapist using hypertonic saline aerosol and salbutamol. MEOPA will be used for nebulization. MEOPA is a gas with analgesic, amnesic and anxiolytic properties.

Control

Standard induced sputum

Group Type: OTHER

Standard induced sputum

Intervention Type: OTHER

Induced sputum with be performed by trained physiotherapist using hypertonic saline aerosol and salbutamol. Oxygen will be used for nebulization.

Interventions

MEOPA

Induced sputum with be performed by trained physiotherapist using hypertonic saline aerosol and salbutamol. MEOPA will be used for nebulization. MEOPA is a gas with analgesic, amnesic and anxiolytic properties.

Intervention Type: DRUG

Standard induced sputum

Induced sputum with be performed by trained physiotherapist using hypertonic saline aerosol and salbutamol. Oxygen will be used for nebulization.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Brest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Brest, University Hospital

Brest, , France

Countries

France

Central Contacts

Pierrick CROS, MD

Role: CONTACT

pierrick.cros@chu-brest.fr

+33298223659

Facility Contacts

Pierrick CROS, MD

Role: primary

pierrick.cros@chu-brest.fr

02 98 22 36 59

Other Identifiers

2024-518197-14-00

Identifier Type: CTIS

Identifier Source: secondary_id

29BRC23.0238

Identifier Type: -

Identifier Source: org_study_id