HFN Versus NIV in Cystic Fibrosis. The HIFEN Study

Cystic Fibrosis Clinical Trial

Official title:

Randomized Cross-over Physiologic Study of High Flow Nasal Oxygen Cannula Versus Non-invasive Ventilation in Cystic Fibrosis. The HIFEN Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02262871
• Other study ID #: REB14-338
• Status: Completed
• Phase: N/A
• First received: October 7, 2014
• Last updated: April 9, 2018
• Start date: December 2014
• Est. completion date: July 30, 2017

Study information

• Verified date: April 2018
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Many patients with cystic fibrosis (CF) require hospitalization and/or Intensive Care Unit (ICU) admission because of acute exacerbation of chronic respiratory failure or for any acute deterioration of clinical status. Non-invasive ventilation (NIV) is the first option for the clinical management of CF patients with moderate-to-severe respiratory distress and NIV has been shown to improve gas exchange, reduce respiratory muscle work and improve pulmonary function in patients with obstructive lung disease in general and those with acute CF exacerbation. High-flow nasal oxygen cannula (HFN) is a relatively new system providing heated and humidified, high-flow (50L/min) oxygen through the nostrils. This device provides a small positive pressure, probably washes-out the pharyngeal dead space, reduces inspiratory resistance, and possibly facilitates secretion clearance. The technique is very well tolerated. From a physiologic standpoint, this device could help CF patients by improving gas exchange, reducing respiratory workload, and facilitating mucus clearance. Non-interrupted delivery may be possible given better clinical tolerance in contrast with bi-level positive pressure NIV. Whether the short-term physiological efficacy of HFN is comparable to NIV is unknown and there is no study on the benefit of HFN in CF patients.

The aim of this study is to compare the physiological effects of HFN and NIV in CF patients requiring ventilatory support. Our hypothesis is that HFN will not be inferior to NIV, as evaluated by breathing pattern, gas exchange, and respiratory workload and will decrease dead space. In addition, comfort and preference between the two techniques will be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 30, 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Age = 18 years

• Cystic fibrosis as defined by clinical features in conjunction with 2 CF causing mutations and/or 2 sweat tests with sweat chloride > 60 mmol/l

• Clinical indication for NIV based on at least one of the following criteria:

• Signs of clinical respiratory distress - RR > 24/min, accessory muscle use, or increased dyspnea

• Progressive increase in arterial PCO2

• Nocturnal hypoventilation treated by NIV but requiring daytime NIV because of clinical worsening

Exclusion criteria:

• Active massive hemoptysis

• Pneumothorax with pleural drainage and persistent air leak

• Hemodynamic instability requiring vasopressors

• Uncooperative

• Recent upper airway or esophageal surgery

• Patients with skin or chest wall or abdominal trauma

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Device:
• High flow nasal oxygen cannula
HFN will be set with an inspiratory flow rate at 45-55 L/min (maximal tolerated flow), temperature at 37°C or 34°C if perceived as too warm, and fraction on inspired oxygen (FiO2) will be adjusted to achieve an oxygen saturation (SpO2) of at least 92%.
• Noninvasive ventilation
The setting of NIV will be appropriately adjusted, based on the clinical assessment of the respiratory therapist in charge and will not be modified during the test.

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (23)

Belkin RA, Henig NR, Singer LG, Chaparro C, Rubenstein RC, Xie SX, Yee JY, Kotloff RM, Lipson DA, Bunin GR. Risk factors for death of patients with cystic fibrosis awaiting lung transplantation. Am J Respir Crit Care Med. 2006 Mar 15;173(6):659-66. Epub 2 — View Citation

Corley A, Caruana LR, Barnett AG, Tronstad O, Fraser JF. Oxygen delivery through high-flow nasal cannulae increase end-expiratory lung volume and reduce respiratory rate in post-cardiac surgical patients. Br J Anaesth. 2011 Dec;107(6):998-1004. doi: 10.10 — View Citation

Cuquemelle E, Pham T, Papon JF, Louis B, Danin PE, Brochard L. Heated and humidified high-flow oxygen therapy reduces discomfort during hypoxemic respiratory failure. Respir Care. 2012 Oct;57(10):1571-7. Epub 2012 Mar 12. — View Citation

Davies JC, Alton EW, Bush A. Cystic fibrosis. BMJ. 2007 Dec 15;335(7632):1255-9. Review. — View Citation

Fauroux B, Burgel PR, Boelle PY, Cracowski C, Murris-Espin M, Nove-Josserand R, Stremler N, Derlich L, Giovanetti P, Clément A; Chronic Respiratory Insufficiency Group of the French National Cystic Fibrosis Federation. Practice of noninvasive ventilation — View Citation

Fauroux B, Nicot F, Essouri S, Hart N, Clément A, Polkey MI, Lofaso F. Setting of noninvasive pressure support in young patients with cystic fibrosis. Eur Respir J. 2004 Oct;24(4):624-30. — View Citation

Fauroux B. Why, when and how to propose noninvasive ventilation in cystic fibrosis? Minerva Anestesiol. 2011 Nov;77(11):1108-14. Epub 2011 May 20. Review. — View Citation

Flume PA. Pulmonary complications of cystic fibrosis. Respir Care. 2009 May;54(5):618-27. Review. — View Citation

Granton JT, Kesten S. The acute effects of nasal positive pressure ventilation in patients with advanced cystic fibrosis. Chest. 1998 Apr;113(4):1013-8. — View Citation

Jones A, Bilton D, Evans TW, Finney SJ. Predictors of outcome in patients with cystic fibrosis requiring endotracheal intubation. Respirology. 2013 May;18(4):630-6. doi: 10.1111/resp.12051. — View Citation

Madden BP, Kariyawasam H, Siddiqi AJ, Machin A, Pryor JA, Hodson ME. Noninvasive ventilation in cystic fibrosis patients with acute or chronic respiratory failure. Eur Respir J. 2002 Feb;19(2):310-3. Erratum in: Eur Respir J. 2002 Sep;20(3):790.. — 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 Respi — View Citation

Matamis D, Soilemezi E, Tsagourias M, Akoumianaki E, Dimassi S, Boroli F, Richard JC, Brochard L. Sonographic evaluation of the diaphragm in critically ill patients. Technique and clinical applications. Intensive Care Med. 2013 May;39(5):801-10. doi: 10.1 — View Citation

Nick JA, Chacon CS, Brayshaw SJ, Jones MC, Barboa CM, St Clair CG, Young RL, Nichols DP, Janssen JS, Huitt GA, Iseman MD, Daley CL, Taylor-Cousar JL, Accurso FJ, Saavedra MT, Sontag MK. Effects of gender and age at diagnosis on disease progression in long — View Citation

Pittman JE, Cutting G, Davis SD, Ferkol T, Boucher R. Cystic fibrosis: NHLBI Workshop on the Primary Prevention of Chronic Lung Diseases. Ann Am Thorac Soc. 2014 Apr;11 Suppl 3:S161-8. doi: 10.1513/AnnalsATS.201312-444LD. Review. — View Citation

Ricard JD. High flow nasal oxygen in acute respiratory failure. Minerva Anestesiol. 2012 Jul;78(7):836-41. Epub 2012 Apr 24. Review. — View Citation

Rittayamai N, Tscheikuna J, Rujiwit P. High-flow nasal cannula versus conventional oxygen therapy after endotracheal extubation: a randomized crossover physiologic study. Respir Care. 2014 Apr;59(4):485-90. doi: 10.4187/respcare.02397. Epub 2013 Sep 17. — View Citation

Roca O, Riera J, Torres F, Masclans JR. High-flow oxygen therapy in acute respiratory failure. Respir Care. 2010 Apr;55(4):408-13. — View Citation

Serra A, Polese G, Braggion C, Rossi A. Non-invasive proportional assist and pressure support ventilation in patients with cystic fibrosis and chronic respiratory failure. Thorax. 2002 Jan;57(1):50-4. — View Citation

Sood N, Paradowski LJ, Yankaskas JR. Outcomes of intensive care unit care in adults with cystic fibrosis. Am J Respir Crit Care Med. 2001 Feb;163(2):335-8. — View Citation

Vignaux L, Vargas F, Roeseler J, Tassaux D, Thille AW, Kossowsky MP, Brochard L, Jolliet P. Patient-ventilator asynchrony during non-invasive ventilation for acute respiratory failure: a multicenter study. Intensive Care Med. 2009 May;35(5):840-6. doi: 10 — View Citation

Vivier E, Mekontso Dessap A, Dimassi S, Vargas F, Lyazidi A, Thille AW, Brochard L. Diaphragm ultrasonography to estimate the work of breathing during non-invasive ventilation. Intensive Care Med. 2012 May;38(5):796-803. doi: 10.1007/s00134-012-2547-7. Ep — View Citation

Young AC, Wilson JW, Kotsimbos TC, Naughton MT. Randomised placebo controlled trial of non-invasive ventilation for hypercapnia in cystic fibrosis. Thorax. 2008 Jan;63(1):72-7. Epub 2007 Aug 3. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The decrease of diaphragmatic workload (thickening fraction of the diaphragm)		30 minutes
Secondary	Respiratory parameters	respiratory rate (RR), minute ventilation	30 minutes
Secondary	Gas exchange	pulse oximetry, transcutaneous carbon dioxide partial pressure (PCO2)	30 minutes
Secondary	Electromyographic activity of the diaphragm		30 minutes