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| Name | Class |
|---|---|
| Fisher and Paykel Healthcare | INDUSTRY |
| LINET | UNKNOWN |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAFEx | Experimental | Electrical 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. |
|
| Standard Care | Active Comparator | Electrical 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fisher and Paykel "HealthCare Airvo™ 3" high flow system | Device | High Flow Nasal Oxygen Delivery Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 72 hours |
| Patient Visual Analogue Scale scores for questions exploring the tolerability of SAFEx treatment compared with that of standard care. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Malcolm AB Sim, MBChB, MD, FRCP, FRCA, FFICM | NHS Greater Glasgow and Clyde | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Critical Care Medicine, Queen Elizabeth University Hospital | Glasgow | Scotland | G51 4TF | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12548031 | Background | 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. | |
| 22356725 | Background | 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. |
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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.
Beginning 3 months and ending 5 years following article publication
Appropriate request made through Enlighten Data Repository (doi will be provided in future publication)
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Participants will be randomised in a 1:1 manner between two treatments at time of extubation: SAFEx treatment or standard care.
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Participants will be randomised in a 1:1 manner using a computer-generated 30 number sequence of '1s' and '2s' from https://www.random.org/ between 1) SAFEx treatment and 2) standard care. A clinician, not involved in the study, will obtain this 30 number sequence and conceal its order within 30 sealed, opaque, numbered envelopes. The investigators will be blinded to the participant's allocation until they have been enrolled in the study, after which the next envelope in the sequence will be opened and treatment allocation will be unblinded.
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| Conventional Oxygen Therapy | Device | Low flow oxygen delivery device (Flow rate between 2 litres per minute and 15 litres per minute) |
|
Questions will ask participants to rate their experience on a 1 to 10 scale for:
|
| 72 hours |
| Withdrawal rate from the study. | The number of participants requesting to withdraw from the study due to inability to tolerate the trial procedures. | 72 hours |
| 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. | 2 hours 50 minutes |
| 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. | 2 hours 50 minutes |
| The failure rate of Electrical Impedance Tomography measurement. | Defined as the proportion of participants in whom impedance data cannot be computed. | 2 hours 50 minutes |
| 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:
| 72 hours |
| The change in global electrical impedance between each group. | The change in end expiratory lung impedance and delta impedance between each group. | 2 hours 50 minutes |
| 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. | 72 hours |
| 21376523 | Background | 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. |
| 27203510 | Background | 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. |
| 18540928 | Background | 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. |
| 27121707 | Background | 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. |
| 23513246 | Background | 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. |
| 25981908 | Background | 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. |
| 25003980 | Background | 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. |
| 28429603 | Background | 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. |
| 31577036 | Background | 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. |
| 22584759 | Background | 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. |
| 20509966 | Background | 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. |
| 34703292 | Background | 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. |
| Background | 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. |
| 41952232 | Derived | Thomson DG, Alcala GC, Watson MJ, Sim MAB. Pre-SAFEx: protocol for a single-centre, randomised, unblinded feasibility trial of Simultaneous Application of Flow at Extubation (SAFEx) in patients requiring intubation and ventilation for the management of acute respiratory failure. Pilot Feasibility Stud. 2026 Apr 8;12(1):72. doi: 10.1186/s40814-026-01817-7. |
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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