HFN Versus NIV in Cystic Fibrosis. The HIFEN Study

NCT02262871 | Completed

• 1 other identifier: REB14-338
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cystic Fibrosis

Keywords

Cystic fibrosis; High-flow nasal oxygen cannula; Non-invasive ventilation; Respiratory distress; Oxygen therapy

Outcome Measures

Primary Outcomes (1)

• The decrease of diaphragmatic workload (thickening fraction of the diaphragm)

  30 minutes

Secondary Outcomes (3)

• Respiratory parameters

  30 minutes

• Gas exchange

  30 minutes

• Electromyographic activity of the diaphragm

  30 minutes

Study Arms (2)

CF patients HFN

EXPERIMENTAL

CF patients who meet the eligibility criteria will be randomized to receive HFN and then crossover to other device.

Device: High flow nasal oxygen cannula

CF patients NIV

EXPERIMENTAL

CF patients who meet the eligibility criteria will be randomized to receive NIV and then crossover to other device.

Device: Noninvasive ventilation

Interventions

High flow nasal oxygen cannula DEVICE

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%.

CF patients HFN

Noninvasive ventilation DEVICE

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.

CF patients NIV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Related Publications (24)

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

  PMID: 20406507 BACKGROUND

• Davies JC, Alton EW, Bush A. Cystic fibrosis. BMJ. 2007 Dec 15;335(7632):1255-9. doi: 10.1136/bmj.39391.713229.AD. No abstract available.

  PMID: 18079549 RESULT

• 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(Suppl 3):S161-8. doi: 10.1513/AnnalsATS.201312-444LD.

  PMID: 24754825 RESULT

• Flume PA. Pulmonary complications of cystic fibrosis. Respir Care. 2009 May;54(5):618-27. doi: 10.4187/aarc0443.

  PMID: 19393106 RESULT

• 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-term survivors of cystic fibrosis. Am J Respir Crit Care Med. 2010 Sep 1;182(5):614-26. doi: 10.1164/rccm.201001-0092OC. Epub 2010 May 6.

  PMID: 20448091 RESULT

• 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. doi: 10.1164/rccm.200410-1369OC. Epub 2005 Dec 30.

  PMID: 16387803 RESULT

• 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. doi: 10.1164/ajrccm.163.2.2003076.

  PMID: 11179102 RESULT

• 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.

  PMID: 23323684 RESULT

• Fauroux B, Burgel PR, Boelle PY, Cracowski C, Murris-Espin M, Nove-Josserand R, Stremler N, Derlich L, Giovanetti P, Clement A; Chronic Respiratory Insufficiency Group of the French National Cystic Fibrosis Federation. Practice of noninvasive ventilation for cystic fibrosis: a nationwide survey in France. Respir Care. 2008 Nov;53(11):1482-9.

  PMID: 18957151 RESULT

• 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.

  PMID: 21602746 RESULT

• 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. doi: 10.1183/09031936.02.00218502.

  PMID: 11866011 RESULT

• Fauroux B, Nicot F, Essouri S, Hart N, Clement 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. doi: 10.1183/09031936.04.0000137603.

  PMID: 15459142 RESULT

• 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. doi: 10.1378/chest.113.4.1013.

  PMID: 9554640 RESULT

• 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. doi: 10.1136/thorax.57.1.50.

  PMID: 11809990 RESULT

• 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. doi: 10.1136/thx.2007.082602. Epub 2007 Aug 3.

  PMID: 17675317 RESULT

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

  PMID: 22531566 RESULT

• 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. doi: 10.4187/respcare.01681. Epub 2012 Mar 12.

  PMID: 22417569 RESULT

• 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: 10.1093/bja/aer265. Epub 2011 Sep 9.

  PMID: 21908497 RESULT

• 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.

  PMID: 24046462 RESULT

• 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.

  PMID: 25003980 RESULT

• 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: 10.1007/s00134-013-2823-1. Epub 2013 Jan 24.

  PMID: 23344830 RESULT

• 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. Epub 2012 Apr 5.

  PMID: 22476448 RESULT

• 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: 10.1007/s00134-009-1416-5. Epub 2009 Jan 29.

  PMID: 19183949 RESULT

• Sklar MC, Dres M, Rittayamai N, West B, Grieco DL, Telias I, Junhasavasdikul D, Rauseo M, Pham T, Madotto F, Campbell C, Tullis E, Brochard L. High-flow nasal oxygen versus noninvasive ventilation in adult patients with cystic fibrosis: a randomized crossover physiological study. Ann Intensive Care. 2018 Sep 5;8(1):85. doi: 10.1186/s13613-018-0432-4.

  PMID: 30187270 DERIVED

MeSH Terms

Conditions

Cystic Fibrosis; Dyspnea

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Laurent Brochard, Dr.

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2014
• First Posted: October 13, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: July 30, 2017
• Last Updated: April 11, 2018

Record last verified: 2018-04

Locations

CA (1)