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Respiratory InsufficiencyPre-SAFExNCT05904652

High Flow Nasal Oxygen at Extubation for Adults Requiring a Breathing Tube for Treating Severe Breathing Difficulties

A study testing Fisher and Paykel "HealthCare Airvo™ 3" high flow system and Conventional Oxygen Therapy in people with Respiratory Insufficiency, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this feasibility study is to learn whether a new approach to breathing tube removal within the Intensive Care Unit is safe and acceptable to participants who require a breathing tube for the management of severe breathing difficulties. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Respiratory Insufficiency
What is being tested?
Fisher and Paykel "HealthCare Airvo™ 3" high flow system and Conventional Oxygen Therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteUnited Kingdom
Study dates
11 Sep 2023to 13 Sep 2024
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

  • Participant aged 18 to 80 years old at time of recruitment to study)
  • Ventilated for greater than or equal to 48 hours with respiratory failure
  • Treating clinician agrees ready for a planned extubation (but pressure support ventilation, fraction of inspired oxygen less than or equal to 40 , positive end expiratory pressure less than or equal to 10 centimetres of water, Respiratory rate less than 20 breaths per minute)
  • Minimal secretions
  • Neurologically intact (In the opinion of the treating clinician, the participant is unlikely to fail extubation due to their neurological status)
  • Cardiovascularly stable (systolic blood pressure greater than or equal to 70 millimetres of mercury, heart rate less than or equal to 150 beats per minute)
  • Written informed consent

Who cannot join

  • Cardiac Implant Device
  • Internal Neurostimulator
  • Unstable Spinal Fracture or Spinal Cord Injury
  • Body Mass Index >50kg/m^2
  • Skin lesions or dressings over electrode belt site
  • Pregnancy or Lactating
Show all 18Show fewer
  • Intercostal Chest Drain (at treating clinician's discretion)
  • Severe type II respiratory failure (arterial partial pressure of carbon dioxide greater than or equal to 12 kilopascals)
  • Severe acidosis (Hydrogen ion concentration greater than or equal to 80 nanomoles per litre)
  • Chronic respiratory disease limiting functional capacity (MRC breathlessness grade IV or V)
  • Severe heart failure (New York Heart Association Grade III or IV)
  • Decreased GCS
  • Cardiovascular instability (systolic blood pressure less than or equal to 69 millimetres of mercury or heart rate greater than or equal to 151 millimetres of mercury )
  • Pulmonary embolism
  • Nasal obstruction
  • Previous bleomycin administration
  • Base of skull fracture
  • Life expectancy less than or equal to 3 months

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Department of Critical Care Medicine, Queen Elizabeth University Hospital

    Glasgow, Scotland, G51 4TF

Other trials in United Kingdom

About this study

Official title: A Randomised, Feasibility Trial of Simultaneous Application of Flow at Extubation (SAFEx) in Patients Requiring Intubation and Ventilation for the Management of Acute Respiratory Failure

The goal of this feasibility study is to learn whether a new approach to breathing tube removal within the Intensive Care Unit is safe and acceptable to participants who require a breathing tube for the management of severe breathing difficulties. The main questions it aims to answer are:

  • What is the recruitment rate to the study over 12 months?
  • Is the study design acceptable and safe to participants?
Read more

Participants will receive high flow nasal oxygen before their breathing tube is removed. The investigators will compare this with standard practice of applying conventional, low-flow oxygen after the breathing tube removed to see if this effects the rate of repeat breathing tube insertion.

The investigators hypothesise that they will recruit 30 participants to the study protocol (15 participants in each group) over 12 months and that our study protocol will be tolerable and acceptable to participants.

Being tested
Fisher and Paykel "HealthCare Airvo™ 3" high flow system, Conventional Oxygen Therapy
Keywords
Extubation Failure, Airway Extubation, Oxygen Inhalation Therapy, Electric Impedance
Medical subject headings
Respiratory Insufficiency

What participants receive

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

  • Fisher and Paykel "HealthCare Airvo™ 3" high flow systemDevice

    High Flow Nasal Oxygen Delivery Device

  • Conventional Oxygen TherapyDevice

    Low flow oxygen delivery device (Flow rate between 2 litres per minute and 15 litres per minute)

Study groups in NCT05904652
Study groupRoleWhat they receive
SAFExExperimentalElectrical Impedance Tomography recording is commenced 15 minutes prior to planned extubation. High Flow Nasal Therapy (HFNT) is commenced at least 10 minutes prior to planned extubation. At 5 minutes before extubation, the flow rate of HFNT should be established at 60 litres per min (or as high as can be tolerated by the participant) and the fraction of inspired oxygen (FiO2) set at 40 percent. Prior to extubation, endotracheal, infraglottic and supraglottic suctioning are performed. Then, the cuff is let down followed by immediate extubation with simultaneous application of HFNT. 10 minutes after extubation, the FiO2 is weaned in a protocolised manner to 21 percent - or as close to 21 percent as possible over 25 minutes. If the participant is safely weaned onto room air, the flow rate of HFNT is then reduced in a protocolised manner over 120 minutes: 60 minutes at 60 litres per minute (or the highest flow rate tolerated) and then 60 minutes at 30 Litres per minute.
Receives: Device: Fisher and Paykel "HealthCare Airvo™ 3" high flow system
Standard CareActive comparatorElectrical Impedance Tomography recording commenced 15 minutes prior to planned extubation. Prior to extubation, endotracheal, infraglottic and supraglottic suctioning are performed. Then, the cuff is let down followed by immediate extubation on to low flow conventional oxygen with a fraction of inspired oxygen of up to 40 percent. Then, the participant is weaned at the discretion of their clinician over the next 2 hours and 35 minutes.
Receives: Device: Conventional Oxygen Therapy

What is being measured

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

  1. The recruitment rate to the study over 12 months with 1:1 randomisation of participants between SAFEx treatment and standard care.

    The associated end point will be the average rate of recruitment per month over 12 months of participants who complete the full study protocol (with a set upper limit of 30 participants recruited to the protocol over 12 months corresponding to a recruitment rate of 2.5 participants per month).

    Measured: 12 months

Secondary outcomes (9)

  1. The incidence of Adverse Events and Serious Adverse Events associated with trial procedures.

    This will focus primarily on aspects of SAFEx and Electrical Impedance Tomography Measurement.

    Measured: 72 hours

  2. Patient Visual Analogue Scale scores for questions exploring the tolerability of SAFEx treatment compared with that of standard care.

    Questions will ask participants to rate their experience on a 1 to 10 scale for:

    • Overall comfort
    • Perceived dyspnoea
    • Ability to speak
    • Ability to hear
    • Ability to clear secretions
    • Sensation of bloating
    • Sensation of dry mouth
    • Sensation of nasal dryness
    • Fear

    Measured: 72 hours

  3. Withdrawal rate from the study.

    The number of participants requesting to withdraw from the study due to inability to tolerate the trial procedures.

    Measured: 72 hours

  4. The rate of completion of the SAFEx weaning protocol.

    The percentage of participants who completed the weaning protocol without breaching any of the physiological participant safety criteria.

    Measured: 2 hours 50 minutes

  5. The duration of weaning tolerated before desaturation occurred.

    The average fraction of inspired oxygen and oxygen flow rate administered in each group before desaturation occurred.

    Measured: 2 hours 50 minutes

  6. The failure rate of Electrical Impedance Tomography measurement.

    Defined as the proportion of participants in whom impedance data cannot be computed.

    Measured: 2 hours 50 minutes

  7. The participant self-rated Visual Analogue Scale score for questions exploring the tolerability of Electrical Impedance Tomography Measurement.

    Questions will ask participants to rate their experience on a 1 to 10 scale for:

    • Overall comfort whilst wearing EIT
    • Overall comfort on removal of EIT
    • Overall ease of breathing with EIT

    Measured: 72 hours

  8. The change in global electrical impedance between each group.

    The change in end expiratory lung impedance and delta impedance between each group.

    Measured: 2 hours 50 minutes

  9. The reintubation rate in each group.

    The rate of repeat intubation will be measured in each group at 24, 48 and 72 hours post-extubation.

    Measured: 72 hours

Timeline

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

  1. First posted15 Jun 2023
  2. Study start11 Sep 2023
  3. Primary completion10 Sep 2024
  4. Study completion13 Sep 2024

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomised in a 1:1 manner between two treatments at time of extubation: SAFEx treatment or standard care.
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05904652
Sponsor's protocol ID
GN23CC122
Acronym
Pre-SAFEx
Status last verified
Sep 2024
First submitted
31 May 2023
Last updated
3 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Anonymised, processed Physiological, EIT and Questionnaire Data that underlies the results reported in this study will be be made available . Raw data will not be shared.

Publications

  • Rothaar RC, Epstein SK. Extubation failure: magnitude of the problem, impact on outcomes, and prevention. Curr Opin Crit Care. 2003 Feb;9(1):59-66. doi: 10.1097/00075198-200302000-00011.

    PubMed 12548031

  • Krinsley JS, Reddy PK, Iqbal A. What is the optimal rate of failed extubation? Crit Care. 2012 Feb 20;16(1):111. doi: 10.1186/cc11185.

    PubMed 22356725

  • Frutos-Vivar F, Esteban A, Apezteguia C, Gonzalez M, Arabi Y, Restrepo MI, Gordo F, Santos C, Alhashemi JA, Perez F, Penuelas O, Anzueto A. Outcome of reintubated patients after scheduled extubation. J Crit Care. 2011 Oct;26(5):502-509. doi: 10.1016/j.jcrc.2010.12.015. Epub 2011 Mar 3.

    PubMed 21376523

  • Levy SD, Alladina JW, Hibbert KA, Harris RS, Bajwa EK, Hess DR. High-flow oxygen therapy and other inhaled therapies in intensive care units. Lancet. 2016 Apr 30;387(10030):1867-78. doi: 10.1016/S0140-6736(16)30245-8. Epub 2016 Apr 28.

    PubMed 27203510

  • 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

  • Roca O, Hernandez G, Diaz-Lobato S, Carratala JM, Gutierrez RM, Masclans JR; Spanish Multidisciplinary Group of High Flow Supportive Therapy in Adults (HiSpaFlow). Current evidence for the effectiveness of heated and humidified high flow nasal cannula supportive therapy in adult patients with respiratory failure. Crit Care. 2016 Apr 28;20(1):109. doi: 10.1186/s13054-016-1263-z.

    PubMed 27121707

  • Parke RL, McGuinness SP. Pressures delivered by nasal high flow oxygen during all phases of the respiratory cycle. Respir Care. 2013 Oct;58(10):1621-4. doi: 10.4187/respcare.02358. Epub 2013 Mar 19.

    PubMed 23513246

  • Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Beduneau G, Deletage-Metreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17.

    PubMed 25981908

  • Maggiore SM, Idone FA, Vaschetto R, Festa R, Cataldo A, Antonicelli F, Montini L, De Gaetano A, Navalesi P, Antonelli M. Nasal high-flow versus Venturi mask oxygen therapy after extubation. Effects on oxygenation, comfort, and clinical outcome. Am J Respir Crit Care Med. 2014 Aug 1;190(3):282-8. doi: 10.1164/rccm.201402-0364OC.

    PubMed 25003980

  • Huang HW, Sun XM, Shi ZH, Chen GQ, Chen L, Friedrich JO, Zhou JX. Effect of High-Flow Nasal Cannula Oxygen Therapy Versus Conventional Oxygen Therapy and Noninvasive Ventilation on Reintubation Rate in Adult Patients After Extubation: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Intensive Care Med. 2018 Nov;33(11):609-623. doi: 10.1177/0885066617705118. Epub 2017 Apr 21.

    PubMed 28429603

  • Thille AW, Muller G, Gacouin A, Coudroy R, Decavele M, Sonneville R, Beloncle F, Girault C, Dangers L, Lautrette A, Cabasson S, Rouze A, Vivier E, Le Meur A, Ricard JD, Razazi K, Barberet G, Lebert C, Ehrmann S, Sabatier C, Bourenne J, Pradel G, Bailly P, Terzi N, Dellamonica J, Lacave G, Danin PE, Nanadoumgar H, Gibelin A, Zanre L, Deye N, Demoule A, Maamar A, Nay MA, Robert R, Ragot S, Frat JP; HIGH-WEAN Study Group and the REVA Research Network. Effect of Postextubation High-Flow Nasal Oxygen With Noninvasive Ventilation vs High-Flow Nasal Oxygen Alone on Reintubation Among Patients at High Risk of Extubation Failure: A Randomized Clinical Trial. JAMA. 2019 Oct 15;322(15):1465-1475. doi: 10.1001/jama.2019.14901.

    PubMed 31577036

  • Soummer A, Perbet S, Brisson H, Arbelot C, Constantin JM, Lu Q, Rouby JJ; Lung Ultrasound Study Group. Ultrasound assessment of lung aeration loss during a successful weaning trial predicts postextubation distress*. Crit Care Med. 2012 Jul;40(7):2064-72. doi: 10.1097/CCM.0b013e31824e68ae.

    PubMed 22584759

  • Bikker IG, Leonhardt S, Reis Miranda D, Bakker J, Gommers D. Bedside measurement of changes in lung impedance to monitor alveolar ventilation in dependent and non-dependent parts by electrical impedance tomography during a positive end-expiratory pressure trial in mechanically ventilated intensive care unit patients. Crit Care. 2010;14(3):R100. doi: 10.1186/cc9036. Epub 2010 May 30.

    PubMed 20509966

  • Wang G, Zhang L, Li B, Niu B, Jiang J, Li D, Yue Z, Weng Y. The Application of Electrical Impedance Tomography During the Ventilator Weaning Process. Int J Gen Med. 2021 Oct 16;14:6875-6883. doi: 10.2147/IJGM.S331772. eCollection 2021.

    PubMed 34703292

  • Hughes, Martin, and Roland Black (eds), Advanced Respiratory Critical Care, Oxford Specialist Handbooks (Oxford, 2011; online edn, Oxford Academic, 1 Oct. 2011), https://doi.org/10.1093/med/9780199569281.001.0001, accessed 5 May 2023.

Questions about this trial

What is this clinical trial studying?

A study testing Fisher and Paykel "HealthCare Airvo™ 3" high flow system and Conventional Oxygen Therapy in people with Respiratory Insufficiency, 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 7 inclusion and 18 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 3 Apr 2026. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The recruitment rate to the study over 12 months with 1:1 randomisation of participants between SAFEx treatment and standard care. (time frame: 12 months). 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 NCT05904652, which also lists 16 linked publications.

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 3 Apr 2026.

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