Acute Hypercapnic Respiratory Failure, Acute Exacerbation of COPD
Conditions
Keywords
Acute exacerbation of COPD, High flow nasal oxygen, High flow nasal insufflation
Brief summary
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.
Interventions
DEVICEHigh flow nasal therapy
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%.
DEVICELow flow oxygen
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.
Sponsors
Belfast Health and Social Care Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Due to the nature of the intervention, the participants , care provider and investigator cannot be blinded but the outcome is objective and data will be analyzed by statistician independent of the study team.
Intervention model description
Randomized controlled parallel group trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult patients \> 18 years of age 2. Acute Hypercapnic respiratory failure with pH \< 7.35 and pCO2 \> 6 KPa
Exclusion criteria
1. Age \< 18 years 2. Pregnant or Breast-Feeding 3. Patient cannot read and understand English 4. Hypercapnia secondary to a drug toxicity or non-pulmonary aetiology 5. Hypercapnia secondary to exacerbation of asthma 6. Contraindication to NIV 7. Contraindication to HFNC 8. Not for escalation to NIV 9. pH \< 7.15 10. GCS 8 or less 11. Shock defined as systolic \< 90 mmHg or a reduction by 20mmHg from usual systolic BP despite volume resuscitation 12. Respiratory or cardio-respiratory arrest 13. Any other indication that requires immediate invasive/non-invasive mechanical ventilation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients requiring NIV in each cohort | 6 hours | Proportion of patients who require NIV by 6 hours of intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PaO2 in Kilopascal | 1 hour, 6 hours and 24 hours. | Blood arterial PaO2 level measured at the pre-specified time-points or at the nearest time-point. |
| pH | 1 hour, 6 hours and 24 hours. | pH measured for acid-base status. |
| Respiratory rate (Breath/minute) | At 1 hour, 6 hours and 24 hours. | Rate of breathing per minute as documented in medical notes. |
| Heart rate (Beat/minute) | 1 hour, 6 hours and 24 hours. | Heart rate per minute as documented in medical notes. |
| Mean arterial pressure in millimeters of mercury | 1 hour, 6 hours and 24 hours. | Mean arterial pressure in millimeters of mercury as documented in medical notes |
| Intubation rate | 1 hour, 6 hours and 24 hours. | — |
| PaCO2 in Kilopascal | 1 hour, 6 hours and 24 hours. | Blood arterial PCO2 level measured at the pre-specified timepoints or at the nearest timepoint. |
| In-hospital mortality | 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 | 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 | From the date of randomization until hospital discharge or date of death from any cause, whichever came first, assessed up to 12 weeks. | — |
| Dyspnoea | 1 hour, 6 hours and 24 hours. | 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. |
| Patient comfort | 1 hour. | 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. |
| ICU admission | From the date of randomization until the date of first documented admission to ICU, assessed up to 12 weeks. | — |
Countries
United Kingdom
Contacts
Primary ContactMurali Shyamsundar, MD, PhD
Backup ContactAsem Alnajada, MSc
Outcome results
None listed