High VS Low Flow Nasal O2 for Acute Hypercapnic Respiratory Failure
High Flow Nasal Cannula Therapy for Initial Oxygen Administration in Acute Hypercapnic Respiratory Failure - A Comparison Study of Two Current Standards of Care
1 other identifier
interventional
82
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2021
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 11, 2020
CompletedFirst Posted
Study publicly available on registry
November 23, 2020
CompletedStudy Start
First participant enrolled
June 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2023
CompletedApril 21, 2022
April 1, 2022
1.7 years
September 11, 2020
April 14, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients requiring NIV in each cohort
Proportion of patients who require NIV by 6 hours of intervention.
6 hours
Secondary Outcomes (13)
PaCO2 in Kilopascal
1 hour, 6 hours and 24 hours.
PaO2 in Kilopascal
1 hour, 6 hours and 24 hours.
pH
1 hour, 6 hours and 24 hours.
Respiratory rate (Breath/minute)
At 1 hour, 6 hours and 24 hours.
Heart rate (Beat/minute)
1 hour, 6 hours and 24 hours.
- +8 more secondary outcomes
Study Arms (2)
High flow nasal therapy (HFNT)
EXPERIMENTALCharacterized 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 COMPARATORCharacterized 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.
Interventions
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%.
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.
Eligibility Criteria
You may qualify if:
- Adult patients \> 18 years of age
- Acute Hypercapnic respiratory failure with pH \< 7.35 and pCO2 \> 6 KPa
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Mater Hospital
Belfast, United Kingdom
Royal Victoria Hospital
Belfast, United Kingdom
Related Publications (1)
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.
PMID: 33419742DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2020
First Posted
November 23, 2020
Study Start
June 13, 2021
Primary Completion
March 1, 2023
Study Completion
March 1, 2023
Last Updated
April 21, 2022
Record last verified: 2022-04