Cystic FibrosisNCT02262871
HFN Versus NIV in Cystic Fibrosis. The HIFEN Study
A study testing High flow nasal oxygen cannula and Noninvasive ventilation in people with Cystic Fibrosis, run by Unity Health Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- High flow nasal oxygen cannula and Noninvasive ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2014to 30 Jul 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Cross-over Physiologic Study of High Flow Nasal Oxygen Cannula Versus Non-invasive Ventilation in Cystic Fibrosis. The HIFEN Study
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
- Being tested
- High flow nasal oxygen cannula, Noninvasive ventilation
- Keywords
- Cystic fibrosis, High-flow nasal oxygen cannula, Non-invasive ventilation, Respiratory distress, Oxygen therapy
- Medical subject headings
- Cystic Fibrosis, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High flow nasal oxygen cannulaDevice
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 ventilationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| CF patients HFN | Experimental | CF patients who meet the eligibility criteria will be randomized to receive HFN and then crossover to other device. Receives: 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. Receives: Device: Noninvasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The decrease of diaphragmatic workload (thickening fraction of the diaphragm)
Measured: 30 minutes
Secondary outcomes (3)
Respiratory parameters
respiratory rate (RR), minute ventilation
Measured: 30 minutes
Gas exchange
pulse oximetry, transcutaneous carbon dioxide partial pressure (PCO2)
Measured: 30 minutes
Electromyographic activity of the diaphragm
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2016
- Study completion30 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent Brochard, Dr., Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02262871
- Sponsor's protocol ID
- REB14-338
- Status last verified
- Apr 2018
- First submitted
- 7 Oct 2014
- Last updated
- 11 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Roca O, Riera J, Torres F, Masclans JR. High-flow oxygen therapy in acute respiratory failure. Respir Care. 2010 Apr;55(4):408-13.
PubMed 20406507Davies 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.
PubMed 18079549Pittman 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.
PubMed 24754825Flume PA. Pulmonary complications of cystic fibrosis. Respir Care. 2009 May;54(5):618-27. doi: 10.4187/aarc0443.
PubMed 19393106Nick 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.
PubMed 20448091Belkin 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.
PubMed 16387803Sood 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.
PubMed 11179102Jones 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.
PubMed 23323684Fauroux 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.
PubMed 18957151Fauroux B. Why, when and how to propose noninvasive ventilation in cystic fibrosis? Minerva Anestesiol. 2011 Nov;77(11):1108-14. Epub 2011 May 20.
PubMed 21602746Madden 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.
PubMed 11866011Fauroux 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.
PubMed 15459142Granton 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.
PubMed 9554640Serra 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.
PubMed 11809990Young 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.
PubMed 17675317
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Cross-over Physiologic Study of High Flow Nasal Oxygen Cannula Versus Non-invasive Ventilation in Cystic Fibrosis. The HIFEN Study
- ClinicalTrials.gov ID
- NCT02262871
- Acronym / sponsor ID
- REB14-338
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic fibrosis, High-flow nasal oxygen cannula, Non-invasive ventilation, Respiratory distress, Oxygen therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- 30 Jul 2017 (actual)
- First posted
- 13 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CF patients HFN | Experimental | Device: High flow nasal oxygen cannulaCF patients who meet the eligibility criteria will be randomized to receive HFN and then crossover to other device. |
| CF patients NIV | Experimental | Device: Noninvasive ventilationCF patients who meet the eligibility criteria will be randomized to receive NIV and then crossover to other device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (6 listed)
- Active massive hemoptysis
- Pneumothorax with pleural drainage and persistent air leak
- Hemodynamic instability requiring vasopressors
- Uncooperative
- Recent upper airway or esophageal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High flow nasal oxygen cannulaHFN 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%. | Device | CF patients HFN |
| Noninvasive ventilationThe 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. | Device | CF patients NIV |
Primary outcome
The decrease of diaphragmatic workload (thickening fraction of the diaphragm)
Time frame: 30 minutes
3 secondary outcomes
Respiratory parameters
Time frame: 30 minutes
Gas exchange
Time frame: 30 minutes
Electromyographic activity of the diaphragm
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2018.
- Background: PubMed 20406507Roca O, Riera J, Torres F, Masclans JR. High-flow oxygen therapy in acute respiratory failure. Respir Care. 2010 Apr;55(4):408-13.
- Results publication: PubMed 18079549Davies 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.
- Results publication: PubMed 24754825Pittman 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.
- Results publication: PubMed 19393106Flume PA. Pulmonary complications of cystic fibrosis. Respir Care. 2009 May;54(5):618-27. doi: 10.4187/aarc0443.
- Results publication: PubMed 20448091Nick 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.
- Results publication: PubMed 16387803Belkin 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.
- Results publication: PubMed 11179102Sood 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.
- Results publication: PubMed 23323684Jones 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.
- Results publication: PubMed 18957151Fauroux 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.
- Results publication: PubMed 21602746Fauroux B. Why, when and how to propose noninvasive ventilation in cystic fibrosis? Minerva Anestesiol. 2011 Nov;77(11):1108-14. Epub 2011 May 20.
- Results publication: PubMed 11866011Madden 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.
- Results publication: PubMed 15459142Fauroux 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent Brochard, Dr. principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High flow nasal oxygen cannula and Noninvasive ventilation in people with Cystic Fibrosis, run by Unity Health Toronto at 1 site in Canada.
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 6 inclusion and 6 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 11 Apr 2018. 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 Canada. 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 decrease of diaphragmatic workload (thickening fraction of the diaphragm) (time frame: 30 minutes). 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 NCT02262871, which also lists 24 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 11 Apr 2018.