Clinical trial NCT04640948: High VS Low Flow Nasal O2 for Acute Hypercapnic Respiratory Failure
Official title: High Flow Nasal Cannula Therapy for Initial Oxygen Administration in Acute Hypercapnic Respiratory Failure - A Comparison Study of Two Current Standards of Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Hypercapnic Respiratory Failure
Acute Exacerbation of COPD
Keywords: Acute exacerbation of COPD
High flow nasal oxygen
High flow nasal insufflation
Lead sponsor: Belfast Health and Social Care Trust
Sponsor class: OTHER
First posted: 2020-11-23
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled parallel group trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients requiring NIV in each cohort
timeFrame: 6 hours
Secondary outcomes:
measure: PaCO2 in Kilopascal
timeFrame: 1 hour, 6 hours and 24 hours.
measure: PaO2 in Kilopascal
timeFrame: 1 hour, 6 hours and 24 hours.
measure: pH
timeFrame: 1 hour, 6 hours and 24 hours.
measure: Respiratory rate (Breath/minute)
timeFrame: At 1 hour, 6 hours and 24 hours.
measure: Heart rate (Beat/minute)
timeFrame: 1 hour, 6 hours and 24 hours.
measure: Mean arterial pressure in millimeters of mercury
timeFrame: 1 hour, 6 hours and 24 hours.
measure: Intubation rate
timeFrame: 1 hour, 6 hours and 24 hours.
measure: ICU admission
timeFrame: From the date of randomization until the date of first documented admission to ICU, assessed up to 12 weeks.
measure: In-hospital mortality
timeFrame: From the date of randomization until the date of death or hospital discharge, whichever came first, assessed up to 12 weeks.
measure: ICU length of stay
timeFrame: 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.
measure: Hospital length of stay
timeFrame: From the date of randomization until hospital discharge or date of death from any cause, whichever came first, assessed up to 12 weeks.
measure: Dyspnoea
timeFrame: 1 hour, 6 hours and 24 hours.
measure: Patient comfort
timeFrame: 1 hour.
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Mater Hospital
city: Belfast
country: United Kingdom
facility: Royal Victoria Hospital
Study officials:
References:
citation: Alnajada A, Blackwood B, Mobrad A, Akhtar A, Shyamsundar M. High-flow nasal cannula therapy for initial oxygen administration in acute hypercapnic respiratory failure: study protocol of randomised controlled unblinded trial. BMJ Open Respir Res. 2021 Jan;8(1):e000853. doi: 10.1136/bmjresp-2020-000853.