High VS Low Flow Nasal O2 for Acute Hypercapnic Respiratory Failure

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: October 2021

Interventions

  • 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%.
  • Device: 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.

Arms, Groups and Cohorts

  • Experimental: High flow nasal therapy (HFNT)
    • Characterized by an elevated arterial CO2 (PaCO2) level of > 6kPa due to ventilatory failure. The ventilatory failure relates to the imbalance between the respiratory demand and the capacity of the respiratory system to match the demand.
  • Active Comparator: Low flow oxygen (LFO)
    • Characterized by an elevated arterial CO2 (PaCO2) level of > 6kPa due to ventilatory failure. The ventilatory failure relates to the imbalance between the respiratory demand and the capacity of the respiratory system to match the demand.

Clinical Trial Outcome Measures

Primary Measures

  • Proportion of patients requiring NIV in each cohort
    • Time Frame: 6 hours
    • Proportion of patients who require NIV by 6 hours of intervention.

Secondary Measures

  • PaCO2 in Kilopascal
    • Time Frame: 1 hour, 6 hours and 24 hours.
    • Blood arterial PCO2 level measured at the pre-specified timepoints or at the nearest timepoint.
  • PaO2 in Kilopascal
    • Time Frame: 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
    • Time Frame: 1 hour, 6 hours and 24 hours.
    • pH measured for acid-base status.
  • Respiratory rate (Breath/minute)
    • Time Frame: At 1 hour, 6 hours and 24 hours.
    • Rate of breathing per minute as documented in medical notes.
  • Heart rate (Beat/minute)
    • Time Frame: 1 hour, 6 hours and 24 hours.
    • Heart rate per minute as documented in medical notes.
  • Mean arterial pressure in millimeters of mercury
    • Time Frame: 1 hour, 6 hours and 24 hours.
    • Mean arterial pressure in millimeters of mercury as documented in medical notes
  • 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
    • Time Frame: 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
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Belfast Health and Social Care Trust
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Murali Shyamsundar, MD, PhD, +44 (0)28 9097 6381, Murali.Shyamsundar@qub.ac.uk

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.