Respiratory FailureFrontiersNCT03223948
Flow veRsus OxygeNaTion In acutE ReSpiratory Failure
A study testing 'Optiflow' in people with Respiratory Failure, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial summary
High flow nasal oxygen therapy has been widely used but guidelines as to the optimal starting flow rate and oxygen percentage are not available. Prolonged exposure to an inappropriately high oxygen concentration should be avoided as there is increasing evidence that the production of oxygen free radicals can lead to… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- 'Optiflow'
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 May 2017to Aug 2018
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged 18-80 at time of recruitment to study) Able to give their own consent (4 "A" Test score of 0 if capacity questionable) Acute respiratory failure but no significant deterioration in the previous hour Receiving conventional oxygen therapy (Hudson, Venturi, non-rebreathing mask or equivalent) up to a maximum of 90% Oxygen saturation ≥ 94% and respiratory rate ≤30
Who cannot join
- Type II respiratory failure (chloride ≤95 and bicarbonate ≥35, on an arterial blood gas or venous sample within 4 weeks) Chronic respiratory disease limiting functional capacity (MRC breathlessness grade IV or V) Pregnancy Heart failure (NYHA Grade III or IV) Decreased GCS Cardiovascular instability (systolic BP ≤90 or heart rate ≥130) Pulmonary embolism Unable to give informed consent Contraindication to receiving high flow nasal oxygen
- Nasal obstruction
- Previous bleomycin administration
- Base of skull fracture
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Queen Elizabeth University Hospital
Glasgow
Malcolm Sim, MB ChB, 01414523430, malcolm.sim@ggc.scot.nhs.uk
Malcolm j watson, MBchB, 01414523430, mwatson@doctors.org.uk
About this study
Official title: A Dose Finding Study to Determine the Optimal Flow Rate and Oxygen Concentration Using High Flow Nasal Oxygenation for Patients With Respiratory Failure.
High flow nasal oxygen therapy has been widely used but guidelines as to the optimal starting flow rate and oxygen percentage are not available. Prolonged exposure to an inappropriately high oxygen concentration should be avoided as there is increasing evidence that the production of oxygen free radicals can lead to lung damage. This pilot dose finding study will determine the optimal flow rate and oxygen concentration using HFNO2 for patients with respiratory failure requiring low, medium or high oxygen concentration from conventional low flow devices. An assessment will also be made of comfort and compliance with HFNO2.
Read the detailed description
The study will recruit a total of between 180 and 270 patients across three hospital sites mainly from high dependence units.
The patients recruited will be stratified into 3 groups according to their oxygen (O2) requirements at recruitment (low, medium and high).
All recruited patients will then be given supplementary O2 using the Optiflow system. Patients from all three recruitment oxygen requirements (low, medium and high) will be randomised to 30 litres, 45 litres or 60 litres per minute with initial a fractional inspired O2 concentration(FiO2) of 0.90 (90% oxygen). The FiO2 is then decreased in 0.05 increments every 5 minutes and the minimum oxygen saturation recorded until it reaches 94%.
End points:
Minimal FiO2 required to maintain saturation above 94% for patients with low, medium and high recruitment oxygen requirements for 30 litres, 45 litres and 60 litres per minute. Use Kruskal Wallis to compare the median FiO2 requirements of those patients who recruited with low, medium and high O2 requirement.
Obtain dose response curve 02 saturation against FiO2 for 3 different flow rates for each of the recruitment 02 requirements and use regression modelling to find best fit dose FiO2 response O2 saturation curves
Patient satisfaction scores and number of patients unable to tolerate the three flow rates in each of the three starting groups and flow rates.
- Conditions
- Respiratory Failure
- Being tested
- 'Optiflow'
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
'Optiflow'Device
High flow nasal oxygen delivery device 'Optiflow'
| Study group | Role | What they receive |
|---|---|---|
| 30 litres per minute | Active comparator | High flow nasal oxygen delivery device 'Optiflow' Receives: Device: 'Optiflow' |
| 45 litres per minute | Active comparator | High flow nasal oxygen delivery device 'Optiflow' Receives: Device: 'Optiflow' |
| 60 litres per minute | Active comparator | High flow nasal oxygen delivery device 'Optiflow' Receives: Device: 'Optiflow' |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median FiO2 (%) needed to be delivered via high flow therapy (Optiflow), at 3 different flow rates, to maintain an oxygen saturation ≥94 % and respiratory rate ≤30 in 3 groups of patients with acute respiratory failure
The median fraction inspired concentration ( FiO2) required to maintain an oxygen saturation ≥94 % and respiratory rate ≤30 in patients with respiratory failure using 'Optiflow' device at three different oxygen flow rates 30 litres 45 litres and 60 litres per minute flow within the three stratified groups of low, median and high oxygen requirements (at recruitment to the study).
Measured: 75 minutes after start of study
Secondary outcomes (2)
Patient satisfaction scores
Comfort of new device when delivering oxygen with each oxygen flow rate:
comfort, bloating, dry mouth, ability to hear and speak in comparison to conventional oxygen therapy
Measured: 75 minutes after start of study
Number of patients unable to tolerate 'Optiflow' device
Failure to complete the 75 minutes with 'Optiflow' at three different oxygen flow rates (30 litres 45 litres and 60 litres per minute flow) within the three stratified groups of low median and high oxygen requirements (at recruitment to study).
Measured: 0 to 75 minutes after start of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start10 May 2017
- Primary completionAug 2018 (estimated)
- Study completionAug 2018 (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 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
- The patients recruited will be divided into 3 groups according to their oxygen (O2) requirements at recruitment (low, medium and high). All recruited patients will then be given supplementary O2 using the Optiflow system. Patients from all three recruitment oxygen requirements (low, medium and high) will be randomised to 30 litres, 45 litres or 60 litres per minute with initial a fractional inspired O2 concentration(FiO2) of 0.90 (90% oxygen). The FiO2 is then decreased in 0.05 increments every 5 minutes and the minimum oxygen saturation recorded until it reaches 94%.
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- Fisher and Paykel Healthcare
- Responsible party
- Sponsor
- Investigators
- Malcolm Sim, MD, MB ChB, Principal investigator, NHS Greater Glasgow and Clyde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03223948
- Sponsor's protocol ID
- GN16RM134
- Acronym
- Frontiers
- Status last verified
- Jul 2017
- First submitted
- 7 Apr 2017
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data not relevant to individual patient after episode of respiratory failure
Publications
Sim MA, Dean P, Kinsella J, Black R, Carter R, Hughes M. Performance of oxygen delivery devices when the breathing pattern of respiratory failure is simulated. Anaesthesia. 2008 Sep;63(9):938-40. doi: 10.1111/j.1365-2044.2008.05536.x. Epub 2008 Jun 6.
PubMed 18540928
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Finding Study to Determine the Optimal Flow Rate and Oxygen Concentration Using High Flow Nasal Oxygenation for Patients With Respiratory Failure.
- ClinicalTrials.gov ID
- NCT03223948
- Acronym / sponsor ID
- Frontiers / GN16RM134
- Conditions
- Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- Fisher and Paykel Healthcare
- Study start
- 10 May 2017 (actual)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 21 Jul 2017 (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.
High flow nasal oxygen therapy has been widely used but guidelines as to the optimal starting flow rate and oxygen percentage are not available. Prolonged exposure to an inappropriately high oxygen concentration should be avoided as there is increasing evidence that the production of oxygen free radicals can lead to lung damage. This pilot dose finding study will determine the optimal flow rate and oxygen concentration using HFNO2 for patients with respiratory failure requiring low, medium or high oxygen concentration from conventional low flow devices. An assessment will also be made of comfort and compliance with HFNO2.
Detailed description
The study will recruit a total of between 180 and 270 patients across three hospital sites mainly from high dependence units.
The patients recruited will be stratified into 3 groups according to their oxygen (O2) requirements at recruitment (low, medium and high).
All recruited patients will then be given supplementary O2 using the Optiflow system. Patients from all three recruitment oxygen requirements (low, medium and high) will be randomised to 30 litres, 45 litres or 60 litres per minute with initial a fractional inspired O2 concentration(FiO2) of 0.90 (90% oxygen). The FiO2 is then decreased in 0.05 increments every 5 minutes and the minimum oxygen saturation recorded until it reaches 94%.
End points:
Minimal FiO2 required to maintain saturation above 94% for patients with low, medium and high recruitment oxygen requirements for 30 litres, 45 litres and 60 litres per minute. Use Kruskal Wallis to compare the median FiO2 requirements of those patients who recruited with low, medium and high O2 requirement.
Obtain dose response curve 02 saturation against FiO2 for 3 different flow rates for each of the recruitment 02 requirements and use regression modelling to find best fit dose FiO2 response O2 saturation curves
Patient satisfaction scores and number of patients unable to tolerate the three flow rates in each of the three starting groups and flow rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The patients recruited will be divided into 3 groups according to their oxygen (O2) requirements at recruitment (low, medium and high). All recruited patients will then be given supplementary O2 using the Optiflow system. Patients from all three recruitment oxygen requirements (low, medium and high) will be randomised to 30 litres, 45 litres or 60 litres per minute with initial a fractional inspired O2 concentration(FiO2) of 0.90 (90% oxygen). The FiO2 is then decreased in 0.05 increments every 5 minutes and the minimum oxygen saturation recorded until it reaches 94%.
| Arm | Type | Receives |
|---|---|---|
| 30 litres per minute | Active comparator | Device: 'Optiflow'High flow nasal oxygen delivery device 'Optiflow' |
| 45 litres per minute | Active comparator | Device: 'Optiflow'High flow nasal oxygen delivery device 'Optiflow' |
| 60 litres per minute | Active comparator | Device: 'Optiflow'High flow nasal oxygen delivery device 'Optiflow' |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient aged 18-80 at time of recruitment to study) Able to give their own consent (4 "A" Test score of 0 if capacity questionable) Acute respiratory failure but no significant deterioration in the previous hour Receiving conventional oxygen therapy (Hudson, Venturi, non-rebreathing mask or equivalent) up to a maximum of 90% Oxygen saturation ≥ 94% and respiratory rate ≤30
Key exclusion criteria (4 listed)
- Type II respiratory failure (chloride ≤95 and bicarbonate ≥35, on an arterial blood gas or venous sample within 4 weeks) Chronic respiratory disease limiting functional capacity (MRC breathlessness grade IV or V) Pregnancy Heart failure (NYHA Grade III or IV) Decreased GCS Cardiovascular instability (systolic BP ≤90 or heart rate ≥130) Pulmonary embolism Unable to give informed consent Contraindication to receiving high flow nasal oxygen
- Nasal obstruction
- Previous bleomycin administration
- Base of skull fracture
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 |
|---|---|---|
| 'Optiflow'High flow nasal oxygen delivery device 'Optiflow' | Device | 30 litres per minute, 45 litres per minute, 60 litres per minute |
Primary outcome
Median FiO2 (%) needed to be delivered via high flow therapy (Optiflow), at 3 different flow rates, to maintain an oxygen saturation ≥94 % and respiratory rate ≤30 in 3 groups of patients with acute respiratory failure
Time frame: 75 minutes after start of study
The median fraction inspired concentration ( FiO2) required to maintain an oxygen saturation ≥94 % and respiratory rate ≤30 in patients with respiratory failure using 'Optiflow' device at three different oxygen flow rates 30 litres 45 litres and 60 litres per minute flow within the three stratified groups of low, median and high oxygen requirements (at recruitment to the study).
2 secondary outcomes
Patient satisfaction scores
Time frame: 75 minutes after start of study
Number of patients unable to tolerate 'Optiflow' device
Time frame: 0 to 75 minutes after start of study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Background: PubMed 18540928Sim MA, Dean P, Kinsella J, Black R, Carter R, Hughes M. Performance of oxygen delivery devices when the breathing pattern of respiratory failure is simulated. Anaesthesia. 2008 Sep;63(9):938-40. doi: 10.1111/j.1365-2044.2008.05536.x. Epub 2008 Jun 6.
- Individual participant dataSharing planned: No. Data not relevant to individual patient after episode of respiratory failure
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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.
Malcolm Sim, MD, MB ChB principal investigator
NHS Greater Glasgow and Clyde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 'Optiflow' in people with Respiratory Failure, run by NHS Greater Glasgow and Clyde at 1 site 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 1 inclusion and 4 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 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Malcolm J watson, PhD, MB ChB (0141 452 3430, mwatson@doctors.org.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median FiO2 (%) needed to be delivered via high flow therapy (Optiflow), at 3 different flow rates, to maintain an oxygen saturation ≥94 % and respiratory rate ≤30 in 3 groups of patients with acute respiratory failure (time frame: 75 minutes after start of study). 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 NCT03223948, 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 Jul 2017.