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Preoxygenation, Apnoea, AnaesthesiaNCT02981511

Optiflow Preoxygenation

A study testing optiflow in people with Preoxygenation, Apnoea, Anaesthesia, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Optiflow can be used to prolong the apnoea period under anaesthesia without falls in blood oxygen saturation. This study is designed to assess whether the Optiflow system can efficiently replace conventional anaesthetic mask and circuit preoxygenation so that it could be used in emergency anaesthesia. Read more about this study

Who is it for?
Ages 20 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Preoxygenation, Apnoea, Anaesthesia
What is being tested?
optiflow
Type of treatment
Medical device
How many people
20 participants
Where
1 siteUnited Kingdom
Study dates
Oct 2016to Jan 2017
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 20 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • healthy (ASA1or 2)

Who cannot join

  • respiratory disease

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site, 1 recruiting
  • University Hospital Southampton

    Southampton, Hants, SO166YD

    Patrick Butler, MBChB, 02380777222 ext. 6283, patrick.butler@uhs.nhs.uk

    Recruiting

Other trials in United Kingdom

About this study

Official title: Assessing the Potential Use of Optiflow as a Preoxygenation Method Prior to Anaesthesia.

Optiflow can be used to prolong the apnoea period under anaesthesia without falls in blood oxygen saturation. This study is designed to assess whether the Optiflow system can efficiently replace conventional anaesthetic mask and circuit preoxygenation so that it could be used in emergency anaesthesia. If so, it would be then be in place in the case of difficult or failed intubation to maintain oxygenation ie: it could preoxygenate and then maintain oxygenation seamlessly.

Read the detailed description

The Optiflow device is used to deliver high flow humidified oxygen/air via nasal cannulae to patients who have respiratory problems. More recently it has been used in patients having surgery on their larynx who are intentionally paralysed under anaesthesia where the surgeon does not want any tubes in the airway. This makes access for surgery easier/possible. Perhaps surprisingly, these patients can be left apnoeic for 30 minutes without falls in blood oxygen levels. The lungs are oxygenated despite there being no in and out breathing/ventilation.

We propose that applying Optiflow at the start of an emergency anaesthetic may be beneficial when an anaesthetist finds that tracheal intubation is impossible - a "failed intubation" scenario. Optiflow might maintain oxygenation during further attempts at intubation or until more skilled anaesthetists arrive.

Another alternative technique presently in common use is for the patient to breathe 100% oxygen via a facemask and conventional anaesthetic circuit for 3 minutes before anaesthesia starts (preoxygenation). This fills the functional residual capacity of the lungs to about 90% oxygen giving an oxygen reserve when the breathing stops until the anaesthetist breathes for them after intubating the trachea. This can result in the maintenance of normal blood oxygen saturation for several minutes longer than would be the case if the lungs had only been exposed to air before anaesthesia.

The research question that we ask is whether we can just use Optiflow instead of the conventional mask/circuit to preoxygenate patients to a similar extent and as quickly as using a facemask so that, in emergency surgery, Optiflow could be used to preoxygenate and then already be in place in case there is a failed intubation. This would enable Optiflow to be used for both purposes seamlessly without the need to switch between the two methods of oxygenation.

Research to date has not yet identified how long Optiflow needs to be in place before anaesthesia for it to be able to produce adequate preoxygenation of the lungs before the patient stops breathing. The 3 minute timing for preoxygenation is important in emergency cases e.g. when there is an emergency caesarean section to be done and every minute before the baby is delivered matters. If it were not possible to preoxygenate a patient's lungs within 3 minutes using Optiflow we would suggest that it is inappropriate to replace conventional mask pre-oxygenation and that its value in emergency anaesthesia might be reduced (although it may still have potential for less urgent anaesthesia when it could be applied for a longer duration before anaesthesia).

This will be a pilot study with 20 healthy volunteer students as subjects who will undergo an up / down sequential analysis of Optiflow pre-oxygenation. They will be recruited from posters inviting them to consider enrolling in the project. They will receive a subject information sheet and will provide written informed consent.

On the study day an individual subject will lie supine on a trolley and the Optiflow device will be fitted ready to administer humidified 100% oxygen at 45 l/min via the device's nasal cannulae. The subject will be asked to breathe normally with a closed mouth and the device will be switched on.

The initial test period will be for 3 minutes and at the end of that time the device will be turned off with the subject holding their breath in inspiration and the subject will then exhale and then breathe normally via a mouthpiece which has a side sampling port connected to a standard gas monitor (as used during anaesthesia) which will measure and display the expired oxygen percentage. This is known to equate very well to the alveolar oxygen fraction in healthy subjects and the target value will be 85%.

After the initial test the subject will be asked to walk around breathing room air for at least 15 minutes to return their lung gases to pre test normality.

The process will then be repeated as before but for a different duration:

If the target of 85% had not been reached within 3 minutes the 2nd test would be for 5 minutes.

If the 85% target had been reached the 2nd test would be reduced to 2.5 minutes.

The test runs would continue in the same up/down fashion until the minimum time required to reach 85% had been identified (to the nearest 30 seconds) or the subject had done test runs up to 10 minutes long without reaching the target.

If the subject wished to split the test runs over more than one session that would be accommodated. They would also be free to leave the study at any time if they so desired.

Subsequent subjects will have an initial test duration adjusted to the average of the previous subjects so that they may not be required to undergo as many tests (this presumes that there is not too much variation within the population) and will be less inconvenienced.

Being tested
optiflow
Medical subject headings
Apnea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • optiflowDevice

    Optiflow device used for preoxygenation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. time to end tidal oxygen content of 0.85

    time to this end point will be found by up/down sequential tests

    Measured: less than 10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2016 (estimated)
  2. Study startOct 2016
  3. Primary completionJan 2017 (estimated)
  4. Study completionJan 2017 (estimated)

Resources

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
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02981511
Sponsor's protocol ID
RHMCRI0333
Status last verified
Dec 2016
First submitted
1 Dec 2016
Last updated
5 Dec 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing optiflow in people with Preoxygenation, Apnoea, Anaesthesia, 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: status not confirmed, as of the sponsor's last update on 5 Dec 2016. 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 patrick butler, MBChB (02380777222 ext. 6283, patrick.butler@uhs.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

time to end tidal oxygen content of 0.85 (time frame: less than 10 minutes). 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 5 Dec 2016; AzTrials last refreshed its copy on 28 Oct 2026.

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