None listed
Conditions
Brief summary
This pilot study will provide a patient centred, pragmatic and individualised process liberating children from mechanical ventilation. The pilot phase of this study will determine feasibility of the trial protocol, randomisation, time to recruit and sample size for the larger multicentre randomised controlled trial (RCT) that will follow. This pilot phase will determine feasibility, efficacy, clarity and agreement by investigators on protocol, and allow testing of randomisation with ability to improve all for the larger RCT.
Interventions
Nasal High Flow (NHF) therapy provided immediately post extubation by the bedside nursing and medical staff via nasal cannula using humidified and heated air with blended oxygen in paediatric intensive care. Duration as long as clinically indicated to provide clinically acceptable oxygenation (no minimum and maximum time frame).
Participants will be allocated to either
Moderate-risk for reintubation arm or Low-risk for reintubation arm.
Children allocated to the Low-risk reintubation arm will
Nasal High Flow (NHF) therapy provided immediately post extubation by the bedside nursing and medical staff via nasal cannula using humidified and heated air with blended oxygen in paediatric intensive care. Duration as long as clinically indicated to provide clinically acceptable oxygenation (no minimum and maximum time frame). Participants will be allocated to either Moderate-risk for reintubation arm or Low-risk for reintubation arm. Children allocated to the Low-risk reintubation arm will be commenced on standard oxygen in the Intensive Care Unit and only if they meet criteria for escalation of respiratory care will be placed on NHF. Criteria for escalation of respiratory care are (one or more criteria) : a.) Oxygen flows on standard oxygen exceed acceptable range (as per hospital standard practice), b.) Target SpO2 cannot be achieved (as per hospital threshold), c.) Severe respiratory distress, d.) PaCO2 = 60 mmHg and pH less than 7.25, e.) Increased lactate or other signs of cardiovascular compromise. Children not requiring escalation will not be included in the comparison. Comparison of effectiveness of NHF therapy between moderate-risk and low-risk arm will be performed. The time spent on NHF will be monitored with the data obtained from the Australian and New Zealand Paediatric Intensive Care Registry (the registry measures precise duration of respiratory support in intensive care).
Sponsors
Gold Coast Hospital and Health Services
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to 16 Years
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria for Moderate Reintubation Risk Group (MRRG)- General ICU study All children less than 16 years of age with parental consent and one or both of the following: • length of mechanical ventilation equal or more than 4 days • oxygen requirement (FiO2 equal or more than 0.4) at extubation Inclusion Criteria for Moderate Reintubation Risk Group (MRRG) - Cardiac ICU study All children less than 16 years of age with parental consent and one or more of the following: • RACHS equal or less than4 • all neonates post cardio-pulmonary bypass and age equal or less than 42 days (post cardiac surgery patients only) belong into MRRG • oxygen requirement (FiO2 equal or more than 0.4) at extubation Inclusion Criteria for Low Reintubation Risk Group (LRRG) – General ICU AND Cardiac ICU studies All children less than 16 years of age with parental consent, who fail standard oxygen therapy and require escalation of respiratory support within the first 72 hours post extubation and one or more of the following: • all children who do not meet either the inclusion criteria for the moderate-risk reintubation group or meet one of the exclusion criteria • length of mechanical ventilation less than 4 days • oxygen requirement prior at extubation (FiO2 less than 0.4)
Exclusion criteria
Excluded are children who require a specific respiratory support (high-risk) or are excluded with the following conditions: • Severe cardiac failure • Child on home respiratory support • Craniofacial abnormalities preventing the use of NHF or CPAP • Underlying pathology requiring CPAP or BIPAP such as severe tracheomalacia or bronchomalacia • Upper gastrointestinal surgery where positive airway pressure is contraindicated • Acknowledged and agreed limitations to care (e.g., do not intubate or resuscitate) or death imminent • Epistaxis • Mid-facial fracture • Previously recruited in the same trial during the same ICU admission • RACHS 5 and 6 • Neuromuscular conditions • Choanal atresia/severe choanal stenosis • Anatomical or acquired airway conditions with a specific airway and respiratory management protocol
Outcome results
None listed