Eligibility

Local study conflicts

• None: Co-enrolment with observational studies is permitted without prior agreemen

Inclusion Criteria:

1. Hospitalised infant aged <12 months with a clinical diagnosis of acute bronchiolitis
   
   AND


2. Clinically assessed at least twice, 15 minutes apart, to have either:
   1. A. SEVERE BRONCHIOLITIS:
      
      Severe respiratory distress (respiratory rate >70/min, or grunting, or marked chest recession) and/or recurrent short apnoeas (>3 per hour, each apnoea lasting >10 sec)
   2. 
      OR
      
      
   3. B. MODERATE BRONCHIOLITIS:
      
      Lack of response to LFNC oxygen up to 2 L/min as indicated by persistent hypoxaemia (SpO2 <90%, or <92% if age < 6 weeks or if underlying health problems present)
   4. and/or
   5. Lack of response to LFNC oxygen up to 2 L/min as indicated by moderate respiratory distress (respiratory rate 55-70/min and/or moderate chest recession)

Exclusion Criteria:

• Clinical decision that patient needs immediate intubation and ventilation for life-threatening hypoxaemia, shock or decreased conscious level.
• Prolonged apnoeas (>10 seconds needing stimulation).
• Ongoing active air leak (pneumothorax, pneumomediastinum).
• Received HSO, HFNC or CPAP for over 2 hours in the previous 24 hours.
• On home ventilation prior to hospital admission.
• Tracheostomy in place.
• Choanal atresia/stenosis, midfacial anomalies or recent craniofacial surgery.
• Previously recruited to the BACHb trial in the last 90 days

If the patient is eligible:

• Gain verbal agreement in principle before proceeding. Explain:
• Taking part in research is likely to improve the quality of their care
• Risks are carefully controlled - research is safe
• Explain the uncertainty that exists with respect to treatment of their condition
• If they change their mind they can withdraw their participation at any point


• The study utilises a deferred consent model (‘research without prior consent’, RWPC) in the BACHb trial. Written informed consent will be obtained from parents/legal guardians as soon as practically possible after randomisation

Step-by-Step Guide to Recruitment:

In the working hours of the research team:

• Monday-Tuesday 07:30 – 20:00
  Wednesday 07:30- 18:00


• Contact the EMROx research team on:
  Mobile 0776818242
  Tel 01865 222003
  Bleep 6680

Page below here still under construction

Out of hours, weekends, and when the research nurse is not available:

Estimated time required to enroll

• Estimated time it will take to enroll a patient

Gather documentation

1. Documentation is stored in the research drawer in the Paediatrics ED, including:
   
   Study protocol
   Recruitment guide
   Treatment flowchart
   Randomisation cards
   Participant information sheet (PIS)
   Consent form
   

Gaining formal consent

• The study utilises a deferred consent model (‘research without prior consent’, RWPC) in the BACHb trial. Written informed consent will be obtained from parents/legal guardians as soon as practically possible after randomisation

Randomisation procedure

1. For patients with severe bronchiolitis: Do not randomise if there is no an available bed in PICU.
2. Eligible patients will be randomised using the sealedenvelope website here. (https://www.sealedenvelope.com/access/apps.) Individuals on the delegation log have individual access.

Carrying out the intervention:

• CPAP will be started in PICU, whilst the patient is in ED the patient will receive standard care
• HSO (Humified Oxygen) – MR850 device on research Lab and HFNC will be started in ED
• Please see the further Guidance notes; available here or click the image below

Disposition and follow-up:

• All patients enrolled in this study will be admitted, due to the severity of their bronchiolitis.

Out of working hours:

• No information

Links for further information:

• information for families and researchers can be found here; scan the QR code or click the image