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

Respiratory Insufficiency Clinical Trial

— Pre-SAFEx  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05904652
• Other study ID #: GN23CC122
• Status: Recruiting
• Phase: N/A
• Start date: September 7, 2023
• Est. completion date: September 7, 2024

Study information

• Verified date: November 2023
• Source: NHS Greater Glasgow and Clyde
• Contact: Malcolm AB Sim, MBChB, MD, FRCP, FRCA, FFICM
• Phone: +44(0)1412014500
• Email: malcolm.sim[@]ggc.scot.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 7, 2024
• Est. primary completion date: September 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Respiratory Insufficiency

Intervention

Device:
• Fisher and Paykel "HealthCare Airvo™ 3" high flow system
High Flow Nasal Oxygen Delivery Device
• Conventional Oxygen Therapy
Low flow oxygen delivery device (Flow rate between 2 litres per minute and 15 litres per minute)

Locations

Country	Name	City	State
United Kingdom	Department of Critical Care Medicine, Queen Elizabeth University Hospital	Glasgow	Scotland

Sponsors (3)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde	Fisher and Paykel Healthcare, LINET

Country where clinical trial is conducted

United Kingdom, 

References & Publications (15)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: JAMA. 2020 Feb 25;323(8):793. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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	72 hours
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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	72 hours
Secondary	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
Secondary	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