Acute Hypercapnic Respiratory FailureNCT04640948
High VS Low Flow Nasal O2 for Acute Hypercapnic Respiratory Failure
A study testing High flow nasal therapy and Low flow oxygen in people with Acute Hypercapnic Respiratory Failure and Acute Exacerbation of COPD, run by Belfast Health and Social Care Trust at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Hypercapnic Respiratory Failure, Acute Exacerbation of COPD
- What is being tested?
- High flow nasal therapy and Low flow oxygen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 13 Jun 2021to Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients > 18 years of age
- Acute Hypercapnic respiratory failure with pH < 7.35 and pCO2 > 6 KPa
Who cannot join
- Age < 18 years
- Pregnant or Breast-Feeding
- Patient cannot read and understand English
- Hypercapnia secondary to a drug toxicity or non-pulmonary aetiology
- Hypercapnia secondary to exacerbation of asthma
- Contraindication to NIV
Show all 13Show fewer
- Contraindication to HFNC
- Not for escalation to NIV
- pH < 7.15
- GCS 8 or less
- Shock defined as systolic < 90 mmHg or a reduction by 20mmHg from usual systolic BP despite volume resuscitation
- Respiratory or cardio-respiratory arrest
- Any other indication that requires immediate invasive/non-invasive mechanical ventilation
Trial locations and contacts
2 sites in 1 country.
Asem Alnajada, MSc contact
United Kingdom2 sites, 2 recruiting
- Recruiting
Mater Hospital
Belfast
- Recruiting
Royal Victoria Hospital
Belfast
About this study
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
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.
Read more
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.
- Being tested
- High flow nasal therapy, Low flow oxygen
- Keywords
- Acute exacerbation of COPD, High flow nasal oxygen, High flow nasal insufflation
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High flow nasal therapyDevice
Also called High flow nasal insufflation
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 oxygenDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| High flow nasal therapy (HFNT) | Experimental | 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. Receives: Device: High flow nasal therapy |
| Low flow oxygen (LFO) | Active comparator | 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. Receives: Device: Low flow oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients requiring NIV in each cohort
Proportion of patients who require NIV by 6 hours of intervention.
Measured: 6 hours
Secondary outcomes (13)
PaCO2 in Kilopascal
Blood arterial PCO2 level measured at the pre-specified timepoints or at the nearest timepoint.
Measured: 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.
Measured: 1 hour, 6 hours and 24 hours.
pH
pH measured for acid-base status.
Measured: 1 hour, 6 hours and 24 hours.
Respiratory rate (Breath/minute)
Rate of breathing per minute as documented in medical notes.
Measured: At 1 hour, 6 hours and 24 hours.
Heart rate (Beat/minute)
Heart rate per minute as documented in medical notes.
Measured: 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
Measured: 1 hour, 6 hours and 24 hours.
Intubation rate
Measured: 1 hour, 6 hours and 24 hours.
ICU admission
Measured: From the date of randomization until the date of first documented admission to ICU, assessed up to 12 weeks.
In-hospital mortality
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 1 hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start13 Jun 2021
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Hypercapnic Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled parallel group trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Belfast Health and Social Care Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04640948
- Sponsor's protocol ID
- 19106MA-AS
- Status last verified
- Apr 2022
- First submitted
- 11 Sep 2020
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD may be shared on request to the Principal Investigator and will be decided on a case by case basis.
Publications
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.
PubMed 33419742
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04640948
- Acronym / sponsor ID
- 19106MA-AS
- Keywords
- Acute exacerbation of COPD, High flow nasal oxygen, High flow nasal insufflation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Belfast Health and Social Care TrustUniversity, hospital or other
- Study start
- 13 Jun 2021 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 23 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled parallel group trial
| Arm | Type | Receives |
|---|---|---|
| High flow nasal therapy (HFNT) | Experimental | Device: High flow nasal therapyCharacterized 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. |
| Low flow oxygen (LFO) | Active comparator | Device: Low flow oxygenCharacterized 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients > 18 years of age
- Acute Hypercapnic respiratory failure with pH < 7.35 and pCO2 > 6 KPa
Key exclusion criteria (13 listed)
- Age < 18 years
- Pregnant or Breast-Feeding
- Patient cannot read and understand English
- Hypercapnia secondary to a drug toxicity or non-pulmonary aetiology
- Hypercapnia secondary to exacerbation of asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High flow nasal therapyAlso: High flow nasal insufflationControlled 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 | High flow nasal therapy (HFNT) |
| Low flow oxygenControlled 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. | Device | Low flow oxygen (LFO) |
Primary outcome
Proportion of patients requiring NIV in each cohort
Time frame: 6 hours
Proportion of patients who require NIV by 6 hours of intervention.
13 secondary outcomes
PaCO2 in Kilopascal
Time frame: 1 hour, 6 hours and 24 hours.
PaO2 in Kilopascal
Time frame: 1 hour, 6 hours and 24 hours.
pH
Time frame: 1 hour, 6 hours and 24 hours.
Respiratory rate (Breath/minute)
Time frame: At 1 hour, 6 hours and 24 hours.
Heart rate (Beat/minute)
Time frame: 1 hour, 6 hours and 24 hours.
Mean arterial pressure in millimeters of mercury
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
Time frame: 1 hour, 6 hours and 24 hours.
Patient comfort
Time frame: 1 hour.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Derived from this study: PubMed 33419742Alnajada 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.
- Individual participant dataSharing planned: Undecided. IPD may be shared on request to the Principal Investigator and will be decided on a case by case basis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asem Alnajada, MSc contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High flow nasal therapy and Low flow oxygen in people with Acute Hypercapnic Respiratory Failure and Acute Exacerbation of COPD, run by Belfast Health and Social Care Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Murali Shyamsundar, MD, PhD (+44 (0)28 9097 6381, Murali.Shyamsundar@qub.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients requiring NIV in each cohort (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04640948, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2022.