None listed
Conditions
Brief summary
Induced coma and breathing machines have become synonymous with intensive care units (ICU). Breathing machines are undoubtedly life-saving in many situations where a person can’t breathe for themselves. Despite it being one of the most potent life-sustaining technology available, it causes significant increases in hospital length of stay, an increased hospital cost burden and a leading cause of distress for patients and families in ICU. Non-invasive alternatives such as nasal high-flow oxygen delivery systems or pressurised face masks are usually used as first line treatment to prevent a breathing machine. Low oxygen levels can also be improved with the addition of nitric oxide gas. One study has demonstrated a trend toward decreased need for breathing machines for a portion of patients receiving nasal high-flow oxygen and nitric oxide gas, however this research remains sparse. Our study will examine the feasibility and clinical outcomes of comparing nasal high-flow oxygen alone over nasal high-flow oxygen with nitric oxide gas in preventing patients to require a breathing machine. Based on previous research and physiological rationale, we hypothesise the latter to be superior.
Interventions
High-flow oxygen (HFO2) combined with Nitric Oxide (NO) gas as per the following protocol:
• Initial fraction of inspired oxygen (FiO2) set at 100% with an initial flow of 60L/min
• NO set at 20 parts per million (ppm) via high-flow nasal cannula (HFNC) as per local clinical work unit guideline. NO will be initiated by ICU nursing staff following medical approval. *Ratio of oxygen to nitric oxide is not calculable due to differences in units of measurement.
• HFO2+NO support for a minimum of 24
High-flow oxygen (HFO2) combined with Nitric Oxide (NO) gas as per the following protocol: • Initial fraction of inspired oxygen (FiO2) set at 100% with an initial flow of 60L/min • NO set at 20 parts per million (ppm) via high-flow nasal cannula (HFNC) as per local clinical work unit guideline. NO will be initiated by ICU nursing staff following medical approval. *Ratio of oxygen to nitric oxide is not calculable due to differences in units of measurement. • HFO2+NO support for a minimum of 24 hours, initiated as soon as possible following consent to trial. However, if emergency treatment is required rapidly, and the involvement in the research carries no more risk to participants than not participating, study procedures will be performed and consent to continue will be sought from the substitute decision maker (SDM), or the participant, should they regain capacity to consent as soon as possible (within a maximum of three days) • HFO2+NO will be delivered with humidification (approximately 98% humidity delivered at 37°C to the nares) • Flows down-titrated in increments of 10L/min if needed for tolerance, to a minimum of 30L/min corresponding with FiO2 listed in the table below: Flow rate FiO2 50-60L/min 0.6 – 1.0 40L/min 0.4-0.6 30L/min 0.21-0.4 • After 24 hours, wean NO 1ppm every 20 minutes as per local clinical work unit guideline or as directed by the ICU Consultant • Audits of electronic notes (capturing continuous measures) within ICU will occur to assess adherence to the intervention.
Sponsors
Metro North Hospital and Health Service
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Age greater than or equal to 18 years, meeting the following criteria o De novo type I respiratory failure (hypoxaemia in the absence of chronic lung condition) (41) o PF ratio <300mmHg o High flow nasal cannula determined by ICU medical team to be primary method for delivery of oxygen therapy o Anticipated high-flow oxygen (HFO2) requirement >24 hours o Arterial line in-situ for blood gas sampling • Ability to provide informed consent, or consent via a substitute decision maker
Exclusion criteria
• Underlying chronic respiratory failure or exacerbation of asthma (including COPD or another chronic respiratory disease) • Documented cardiogenic pulmonary oedema or acute coronary syndrome • Hypercapnic respiratory failure with PaCO2 > 45mmHg • Deterioration of neurologic status demonstrated by Glasgow Coma Scale (GCS) less than or equal to 12 • Urgent need for intubation (evaluated by the medical officer in charge) • Haemodynamic instability (defined by systolic arterial blood pressure <90mmHg or mean arterial blood pressure <65 mmHg) • Use of vasopressors • Do not intubate orders • Enrolled in any other trial of targeted oxygen therapy
Outcome results
None listed