Unrecognized ConditionNCT03766646
Preoxygenation With Optiflow™ - the Effect of Speech on Lung Oxygenation.
A study testing Optiflow in people with Unrecognized Condition, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
If a patient speaks during the process of preoxygenation with high-flow nasal oxygen via the Optiflow™ system, is the efficacy reduced as measured by end-tidal lung oxygen content? Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Unrecognized Condition
- What is being tested?
- Optiflow
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Oct 2018to 16 Nov 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI 18-35, ASA category 1 or 2
Who cannot join
- Inability to read/ follow instructions, Heavily sedated
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospital Southampton
Southampton, Hants, SO16 6YD
About this study
Official title: Preoxygenation With High Flow Nasal Oxygenation Using Optiflow - Does Speech Have an Effect on The End Tidal Oxygen Achieved When Compared to Closed Mouth Nasal Breathing?
If a patient speaks during the process of preoxygenation with high-flow nasal oxygen via the Optiflow™ system, is the efficacy reduced as measured by end-tidal lung oxygen content?
Read the detailed description
This is a randomised controlled trial on 34 patients undergoing routine elective surgery at the Princess Anne Hospital, Southampton. The study will take place from September 2018 to January 2019 and involve preoxygenating all participants for three minutes using the Optiflow™ device. During this time, participants will be instructed to either read aloud a standardised text or to breathe through their nose with a closed mouth. At the end of 3 minutes, the primary outcome, ETO2, will be measured and recorded.
- Conditions
- Unrecognized Condition
- Being tested
- Optiflow
- Keywords
- Optiflow, High Flow Nasal Oxygen, Preoxygenation, Speech
- Medical subject headings
- Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OptiflowDevice
Also called HFNO, High Flow Nasal Oxygen
45l.min oxygen
| Study group | Role | What they receive |
|---|---|---|
| Speech | Experimental | Participants were asked to read a standardised script aloud for 3 minutes whilst receiving oxygen from the Optiflow device. At the end of 3 minutes End Tidal Oxygen was measured and recorded. Receives: Device: Optiflow |
| Non-speech | Active comparator | Participants were asked to breathe in and out of their nose for 3 minutes, with a closed mouth, whilst receiving oxygen from the Optiflow device. At the end of 3 minutes End Tidal Oxygen was measured and recorded. Receives: Device: Optiflow |
What is being measured
The primary outcome is the main question the study is designed to answer.
End Tidal Oxygen Fraction
Oxygen fraction in first expired breath post preoxygenation
Measured: At the end of 3 minutes preoxygenation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start18 Oct 2018
- Primary completion16 Nov 2018
- Study completion16 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Unrecognized ConditionStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were assigned to either the 'Speech' arm or 'Non-speech' arm of the study
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Butler, Principal investigator, Unvistery Hospital Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03766646
- Sponsor's protocol ID
- RHM CR10369
- Status last verified
- Oct 2020
- First submitted
- 5 Dec 2018
- Last updated
- 30 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoxygenation With High Flow Nasal Oxygenation Using Optiflow - Does Speech Have an Effect on The End Tidal Oxygen Achieved When Compared to Closed Mouth Nasal Breathing?
- ClinicalTrials.gov ID
- NCT03766646
- Acronym / sponsor ID
- RHM CR10369
- Conditions
- Unrecognized Condition
- Keywords
- Optiflow, High Flow Nasal Oxygen, Preoxygenation, Speech
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Study start
- 18 Oct 2018 (actual)
- Primary completion
- 16 Nov 2018 (actual)
- Study completion
- 16 Nov 2018 (actual)
- First posted
- 6 Dec 2018 (actual)
- Results
- Posted 30 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
If a patient speaks during the process of preoxygenation with high-flow nasal oxygen via the Optiflow™ system, is the efficacy reduced as measured by end-tidal lung oxygen content?
Detailed description
This is a randomised controlled trial on 34 patients undergoing routine elective surgery at the Princess Anne Hospital, Southampton. The study will take place from September 2018 to January 2019 and involve preoxygenating all participants for three minutes using the Optiflow™ device. During this time, participants will be instructed to either read aloud a standardised text or to breathe through their nose with a closed mouth. At the end of 3 minutes, the primary outcome, ETO2, will be measured and recorded.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients were assigned to either the 'Speech' arm or 'Non-speech' arm of the study
| Arm | Type | Receives |
|---|---|---|
| Speech | Experimental | Device: OptiflowParticipants were asked to read a standardised script aloud for 3 minutes whilst receiving oxygen from the Optiflow device. At the end of 3 minutes End Tidal Oxygen was measured and recorded. |
| Non-speech | Active comparator | Device: OptiflowParticipants were asked to breathe in and out of their nose for 3 minutes, with a closed mouth, whilst receiving oxygen from the Optiflow device. At the end of 3 minutes End Tidal Oxygen was measured and recorded. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI 18-35, ASA category 1 or 2
Key exclusion criteria (1 listed)
- Inability to read/ follow instructions, Heavily sedated
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 |
|---|---|---|
| OptiflowAlso: HFNO, High Flow Nasal Oxygen45l.min oxygen | Device | Non-speech, Speech |
Primary outcome
End Tidal Oxygen Fraction
Time frame: At the end of 3 minutes preoxygenation
Oxygen fraction in first expired breath post preoxygenation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Patrick Butler principal investigator
Unvistery Hospital Southampton
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 Unrecognized Condition, run by University Hospital Southampton NHS Foundation Trust 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 1 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: finished, as of the sponsor's last update on 30 Oct 2020. 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?
Yes. Results are posted in the registry (first posted 30 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
End Tidal Oxygen Fraction (time frame: At the end of 3 minutes preoxygenation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2020.