Chronic lung conditions such as smoking related lung damage lead to breathing fail. This results in accumulation of gases such as carbon-di-oxide in the body especially during periods of illness known as exacerbation. Current management of carbon-di-oxide accumulation is administration of oxygen, nebulisers, antibiotics etc and if necessary, provide a tight fitting mask around the face to provide breathing support. If this fails, then a patient is placed on a mechanical ventilator. The tight fitting mask therapy is also called non-invasive ventilation and is used widely but patients acceptability of the therapy is limited. Providing a high flow of air with some oxygen could potentially provide the same benefit of the non-invasive ventilation and may also be better accepted by patients. Currently the knowledge and evidence from studies suggest a beneficial role for this high flow therapy but this has not been investigated in well designed studies. In the proposed study we aim to investigate whether use of the high flow therapy reduces the need for non-invasive ventilation in patients who present with a recent onset accumulation of carbon-di-oxide in their body due to long-term lung disease. If this shows benefit, it will lead to a bigger trial with patient benefiting by reduction in the non-invasive ventilation or indeed a need for an invasive breathing machine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
82
Controlled oxygen administration using at least 20 L/min of flow rate and titrated up as tolerated. Titration of supplemental oxygen to an arterial saturation between 88 - 92%.
Controlled oxygen administration using (venturi mask or nasal cannulae) titrated to an arterial saturation between 88 - 92% as the initial oxygen administration method with a flow rate of \<20 L/min.
Mater Hospital
Belfast, United Kingdom
RECRUITINGRoyal Victoria Hospital
Belfast, United Kingdom
RECRUITINGProportion of patients requiring NIV in each cohort
Proportion of patients who require NIV by 6 hours of intervention.
Time frame: 6 hours
PaCO2 in Kilopascal
Blood arterial PCO2 level measured at the pre-specified timepoints or at the nearest timepoint.
Time frame: 1 hour, 6 hours and 24 hours.
PaO2 in Kilopascal
Blood arterial PaO2 level measured at the pre-specified time-points or at the nearest time-point.
Time frame: 1 hour, 6 hours and 24 hours.
pH
pH measured for acid-base status.
Time frame: 1 hour, 6 hours and 24 hours.
Respiratory rate (Breath/minute)
Rate of breathing per minute as documented in medical notes.
Time frame: At 1 hour, 6 hours and 24 hours.
Heart rate (Beat/minute)
Heart rate per minute as documented in medical notes.
Time frame: 1 hour, 6 hours and 24 hours.
Mean arterial pressure in millimeters of mercury
Mean arterial pressure in millimeters of mercury as documented in medical notes
Time frame: 1 hour, 6 hours and 24 hours.
Intubation rate
Time frame: 1 hour, 6 hours and 24 hours.
ICU admission
Time frame: From the date of randomization until the date of first documented admission to ICU, assessed up to 12 weeks.
In-hospital mortality
Time frame: From the date of randomization until the date of death or hospital discharge, whichever came first, assessed up to 12 weeks.
ICU length of stay
Time frame: From the date of ICU admission until the date of last documented ICU discharge or date of death from any cause, whichever came first, assessed up to 12 weeks.
Hospital length of stay
Time frame: From the date of randomization until hospital discharge or date of death from any cause, whichever came first, assessed up to 12 weeks.
Dyspnoea
Dyspnoea will be assessed assessment using a visual analogue scale (VAS), score range 0-10, higher values represent a better outcome)) if patient has capacity or the Likert scale (score range 1-5; higher values represent a better outcome) to be completed by the clinical team (doctor/nurse/physio) if the patient lacks capacity.
Time frame: 1 hour, 6 hours and 24 hours.
Patient comfort
Comfort will be assessed assessment using a visual analogue scale (VAS), score range 0-10, higher values represent a better outcome)) if patient has capacity or the Likert scale (score range 1-5; higher values represent a better outcome) to be completed by the clinical team (doctor/nurse/physio) if the patient lacks capacity.
Time frame: 1 hour.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.