High VS Low Flow Nasal O2 for Acute Hypercapnic Respiratory Failure

Acute Hypercapnic Respiratory Failure Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04640948
• Other study ID #: 19106MA-AS
• Status: Recruiting
• Phase: N/A
• Start date: June 13, 2021
• Est. completion date: March 2023

Study information

• Verified date: April 2022
• Source: Belfast Health and Social Care Trust
• Contact: Murali Shyamsundar, MD, PhD
• Phone: +44 (0)28 9097 6381
• Email: Murali.Shyamsundar[@]qub.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Exacerbation of COPD
• Acute Hypercapnic Respiratory Failure
• Hypercapnia
• Respiratory Insufficiency

Intervention

Device:
• High 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%.
• Low 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.

Locations

Country	Name	City	State
United Kingdom	Mater Hospital	Belfast
United Kingdom	Royal Victoria Hospital	Belfast

Sponsors (1)

Lead Sponsor	Collaborator
Belfast Health and Social Care Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients requiring NIV in each cohort	Proportion of patients who require NIV by 6 hours of intervention.	6 hours
Secondary	PaCO2 in Kilopascal	Blood arterial PCO2 level measured at the pre-specified timepoints or at the nearest timepoint.	1 hour, 6 hours and 24 hours.
Secondary	PaO2 in Kilopascal	Blood arterial PaO2 level measured at the pre-specified time-points or at the nearest time-point.	1 hour, 6 hours and 24 hours.
Secondary	pH	pH measured for acid-base status.	1 hour, 6 hours and 24 hours.
Secondary	Respiratory rate (Breath/minute)	Rate of breathing per minute as documented in medical notes.	At 1 hour, 6 hours and 24 hours.
Secondary	Heart rate (Beat/minute)	Heart rate per minute as documented in medical notes.	1 hour, 6 hours and 24 hours.
Secondary	Mean arterial pressure in millimeters of mercury	Mean arterial pressure in millimeters of mercury as documented in medical notes	1 hour, 6 hours and 24 hours.
Secondary	Intubation rate		1 hour, 6 hours and 24 hours.
Secondary	ICU admission		From the date of randomization until the date of first documented admission to ICU, assessed up to 12 weeks.
Secondary	In-hospital mortality		From the date of randomization until the date of death or hospital discharge, whichever came first, assessed up to 12 weeks.
Secondary	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.
Secondary	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.
Secondary	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.	1 hour, 6 hours and 24 hours.
Secondary	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.	1 hour.