Acute Respiratory FailureHFNCNCT03460119
High Flow Nasal Cannula in the Emergency Department
An observational study of Acute Respiratory Failure, run by Hospital Italiano de Buenos Aires.
Trial summary
The aim of this study was to describe the changes in respiratory rate, heart rate and dyspnea, before and after using HFNC in patients presenting to our emergency department with ARF. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- High Flow Nasal Cannula Oxygen
- Type of treatment
- Medical device
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2015to 31 Jan 2017
- Phase
- Observational
- 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
Study population: Patients with and without a history of lung disease who used high flow nasal cannula. We defined clinical signs of acute respiratory failure based on the presence of a breathing frequency ≥ 25 breath/min and increase work of breathing evidence by dyspnea, in-drawing, accessory-muscle use and/or diaphoresis, despite conventional oxygen therapy ≥ 6 l/min.
Who may be able to join
- patients aged ≥ 18 years
- attended between July 1st, 2015 and January 31st , 2017 in the Emergency Department of the Hospital Italiano de Buenos Aires
- with clinical signs of acute respiratory failure
Who cannot join
- Pulse oximetry > 90% breathing room air
About this study
Official title: Use of High-Flow Nasal Cannula for Acute Respiratory Failure in the Emergency Department
The aim of this study was to describe the changes in respiratory rate, heart rate and dyspnea, before and after using HFNC in patients presenting to our emergency department with ARF.
Read the detailed description
A retrospective cohort study was performed. To all adults presenting to the emergency department who used high flow nasal cannula to treat clinical signs of acute respiratory failure based on the presence of a breathing frequency ≥ 25 breath/min and increase work of breathing evidence by dyspnea, in-drawing, accessory-muscle use and/or diaphoresis despite conventional oxygen therapy ≥ 6 l/min. Demographic variables and clinical and gasometric parameters before and after two hours using HFNC were recorded.
- Conditions
- Acute Respiratory Failure
- Being tested
- High Flow Nasal Cannula Oxygen
- Keywords
- High Flow Nasal Cannula, Emergency department, Respiratory care
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Flow Nasal Cannula OxygenDevice
The high flow device that we used was an air oxygen blender (Whisper FlowⓇ), which allows FiO2 adjustment between 0.30 and 1.0 and can deliver a gas flow from 10 to 150 l/min. The gas mixture was routed from a heated humidifier (MR850 with MR 290 chamber) through a one line heated inspiratory circuit (RT241) to the subject at a temperature of 37°C via a nasal cannula (OptiflowⓇ).
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate
The closest value of Heart Rate before starting HFNC, and two hours later was collected from the electronic clinical history.
Measured: 2 hours
Respiratory Rate
The closest value of Respiratory Rate before starting HFNC, and two hours later was collected from the electronic clinical history.
Measured: 2 hours
Dyspnea
The closest value of Dyspnea (Modified Borg Dyspnea scale) before starting HFNC, and two hours later was collected from the electronic clinical history. The Modified Borg Dyspnea Scale is a rated numerical score used to measure dyspnea. This scale has a minimum value of 0 ( represent no dyspnea) and a maximum value of 10 (worse dyspnea).
Measured: 2 hours
Secondary outcomes (8)
Initial HFNC setting
The gas flow rate and the fraction of inspired oxygen at the HFNC initiation of treatment were collected from the electronic clinical history.
Measured: 2 hours
Acute respiratory failure etiology
Presence of a breathing frequency ≥ 25 breath/min and increase work of breathing evidence by dyspnea, in-drawing, accessory-muscle use and/or diaphoresis despite conventional oxygen therapy ≥ 6 l/min.
Measured: 3 minutes
Average time of use the HFNC
The total hours of use of HFNC were collected from the electronic clinical history.
Measured: until 28 days
Delay of HFNC treatment
The hours between the admission to HFNC initiation were collected from the electronic clinical history.
Measured: until 24hs
Efficacy of HFNC treatment
When the patient did not need for escalation to other non-invasive or invasive ventilatory support.
Measured: 28 days
Failure of HFNC treatment
When the patient need non-invasive or invasive ventilatory support or died. The type of ventilatory support post-failure were collected from the electronic clinical history.
Measured: 28 days
Mortality rate at 28 day from ED admission
The number of patients who died after requiring HFNCO were collected from the electronic clinical history
Measured: 28 days
Palliative Care
Consensus between patient and/or patient´s family and the physician about the care for the terminally ill patient, provided by an organized health service
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start1 Jul 2015
- Primary completion31 Jan 2017
- Study completion31 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vanesa R Ruiz, RT, Principal investigator, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03460119
- Sponsor's protocol ID
- 3106
- Acronym
- HFNC
- Status last verified
- Feb 2018
- First submitted
- 20 Feb 2018
- Last updated
- 9 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27121707El-Khatib MF. High-flow nasal cannula oxygen therapy during hypoxemic respiratory failure. Respir Care. 2012 Oct;57(10):1696-8. doi: 10.4187/respcare.02072. No abstract available.
PubMed 23013907Sztrymf B, Messika J, Mayot T, Lenglet H, Dreyfuss D, Ricard JD. Impact of high-flow nasal cannula oxygen therapy on intensive care unit patients with acute respiratory failure: a prospective observational study. J Crit Care. 2012 Jun;27(3):324.e9-13. doi: 10.1016/j.jcrc.2011.07.075. Epub 2011 Sep 29.
PubMed 21958974Ferrer M, Esquinas A, Leon M, Gonzalez G, Alarcon A, Torres A. Noninvasive ventilation in severe hypoxemic respiratory failure: a randomized clinical trial. Am J Respir Crit Care Med. 2003 Dec 15;168(12):1438-44. doi: 10.1164/rccm.200301-072OC. Epub 2003 Sep 18.
PubMed 14500259Keenan SP, Sinuff T, Cook DJ, Hill NS. Does noninvasive positive pressure ventilation improve outcome in acute hypoxemic respiratory failure? A systematic review. Crit Care Med. 2004 Dec;32(12):2516-23. doi: 10.1097/01.ccm.0000148011.51681.e2.
PubMed 15599160Rello J, Perez M, Roca O, Poulakou G, Souto J, Laborda C, Balcells J, Serra J, Masclans JR; CRIPS investigators. High-flow nasal therapy in adults with severe acute respiratory infection: a cohort study in patients with 2009 influenza A/H1N1v. J Crit Care. 2012 Oct;27(5):434-9. doi: 10.1016/j.jcrc.2012.04.006. Epub 2012 Jul 2.
PubMed 22762937Frat 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.
PubMed 25981908Kernick J, Magarey J. What is the evidence for the use of high flow nasal cannula oxygen in adult patients admitted to critical care units? A systematic review. Aust Crit Care. 2010 May;23(2):53-70. doi: 10.1016/j.aucc.2010.01.001. Epub 2010 Mar 5.
PubMed 20206546Messika J, Ben Ahmed K, Gaudry S, Miguel-Montanes R, Rafat C, Sztrymf B, Dreyfuss D, Ricard JD. Use of High-Flow Nasal Cannula Oxygen Therapy in Subjects With ARDS: A 1-Year Observational Study. Respir Care. 2015 Feb;60(2):162-9. doi: 10.4187/respcare.03423. Epub 2014 Nov 4.
PubMed 25371400Vargas F, Saint-Leger M, Boyer A, Bui NH, Hilbert G. Physiologic Effects of High-Flow Nasal Cannula Oxygen in Critical Care Subjects. Respir Care. 2015 Oct;60(10):1369-76. doi: 10.4187/respcare.03814. Epub 2015 May 5.
PubMed 25944940Schwabbauer N, Berg B, Blumenstock G, Haap M, Hetzel J, Riessen R. Nasal high-flow oxygen therapy in patients with hypoxic respiratory failure: effect on functional and subjective respiratory parameters compared to conventional oxygen therapy and non-invasive ventilation (NIV). BMC Anesthesiol. 2014 Aug 7;14:66. doi: 10.1186/1471-2253-14-66. eCollection 2014.
PubMed 25110463Lemiale V, Mokart D, Mayaux J, Lambert J, Rabbat A, Demoule A, Azoulay E. The effects of a 2-h trial of high-flow oxygen by nasal cannula versus Venturi mask in immunocompromised patients with hypoxemic acute respiratory failure: a multicenter randomized trial. Crit Care. 2015 Nov 2;19:380. doi: 10.1186/s13054-015-1097-0.
PubMed 26521922Sztrymf B, Messika J, Bertrand F, Hurel D, Leon R, Dreyfuss D, Ricard JD. Beneficial effects of humidified high flow nasal oxygen in critical care patients: a prospective pilot study. Intensive Care Med. 2011 Nov;37(11):1780-6. doi: 10.1007/s00134-011-2354-6. Epub 2011 Sep 27.
PubMed 21946925Lenglet H, Sztrymf B, Leroy C, Brun P, Dreyfuss D, Ricard JD. Humidified high flow nasal oxygen during respiratory failure in the emergency department: feasibility and efficacy. Respir Care. 2012 Nov;57(11):1873-8. doi: 10.4187/respcare.01575. Epub 2012 Mar 13.
PubMed 22417844Rittayamai N, Tscheikuna J, Praphruetkit N, Kijpinyochai S. Use of High-Flow Nasal Cannula for Acute Dyspnea and Hypoxemia in the Emergency Department. Respir Care. 2015 Oct;60(10):1377-82. doi: 10.4187/respcare.03837. Epub 2015 Jun 9.
PubMed 26060321
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of High-Flow Nasal Cannula for Acute Respiratory Failure in the Emergency Department
- ClinicalTrials.gov ID
- NCT03460119
- Acronym / sponsor ID
- HFNC / 3106
- Conditions
- Acute Respiratory Failure
- Keywords
- High Flow Nasal Cannula, Emergency department, Respiratory care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 31 Jan 2017 (actual)
- First posted
- 9 Mar 2018 (actual)
- 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.
The aim of this study was to describe the changes in respiratory rate, heart rate and dyspnea, before and after using HFNC in patients presenting to our emergency department with ARF.
Detailed description
A retrospective cohort study was performed. To all adults presenting to the emergency department who used high flow nasal cannula to treat clinical signs of acute respiratory failure based on the presence of a breathing frequency ≥ 25 breath/min and increase work of breathing evidence by dyspnea, in-drawing, accessory-muscle use and/or diaphoresis despite conventional oxygen therapy ≥ 6 l/min. Demographic variables and clinical and gasometric parameters before and after two hours using HFNC were recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with and without a history of lung disease who used high flow nasal cannula. We defined clinical signs of acute respiratory failure based on the presence of a breathing frequency ≥ 25 breath/min and increase work of breathing evidence by dyspnea, in-drawing, accessory-muscle use and/or diaphoresis, despite conventional oxygen therapy ≥ 6 l/min.
Key inclusion criteria (3 listed)
- patients aged ≥ 18 years
- attended between July 1st, 2015 and January 31st , 2017 in the Emergency Department of the Hospital Italiano de Buenos Aires
- with clinical signs of acute respiratory failure
Key exclusion criteria (1 listed)
- Pulse oximetry > 90% breathing room air
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 Cannula OxygenThe high flow device that we used was an air oxygen blender (Whisper FlowⓇ), which allows FiO2 adjustment between 0.30 and 1.0 and can deliver a gas flow from 10 to 150 l/min. The gas mixture was routed from a heated humidifier (MR850 with MR 290 chamber) through a one line heated inspiratory circuit (RT241) to the subject at a temperature of 37°C via a nasal cannula (OptiflowⓇ). | Device | – |
Primary outcome
Heart Rate
Time frame: 2 hours
The closest value of Heart Rate before starting HFNC, and two hours later was collected from the electronic clinical history.
Respiratory Rate
Time frame: 2 hours
The closest value of Respiratory Rate before starting HFNC, and two hours later was collected from the electronic clinical history.
Dyspnea
Time frame: 2 hours
The closest value of Dyspnea (Modified Borg Dyspnea scale) before starting HFNC, and two hours later was collected from the electronic clinical history. The Modified Borg Dyspnea Scale is a rated numerical score used to measure dyspnea. This scale has a minimum value of 0 ( represent no dyspnea) and a maximum value of 10 (worse dyspnea).
8 secondary outcomes
Initial HFNC setting
Time frame: 2 hours
Acute respiratory failure etiology
Time frame: 3 minutes
Average time of use the HFNC
Time frame: until 28 days
Delay of HFNC treatment
Time frame: until 24hs
Efficacy of HFNC treatment
Time frame: 28 days
Failure of HFNC treatment
Time frame: 28 days
Mortality rate at 28 day from ED admission
Time frame: 28 days
Palliative Care
Time frame: 28 days
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 9 Mar 2018.
- Background: PubMed 27121707Roca 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.
- Background: PubMed 23013907El-Khatib MF. High-flow nasal cannula oxygen therapy during hypoxemic respiratory failure. Respir Care. 2012 Oct;57(10):1696-8. doi: 10.4187/respcare.02072. No abstract available.
- Background: PubMed 21958974Sztrymf B, Messika J, Mayot T, Lenglet H, Dreyfuss D, Ricard JD. Impact of high-flow nasal cannula oxygen therapy on intensive care unit patients with acute respiratory failure: a prospective observational study. J Crit Care. 2012 Jun;27(3):324.e9-13. doi: 10.1016/j.jcrc.2011.07.075. Epub 2011 Sep 29.
- Background: PubMed 14500259Ferrer M, Esquinas A, Leon M, Gonzalez G, Alarcon A, Torres A. Noninvasive ventilation in severe hypoxemic respiratory failure: a randomized clinical trial. Am J Respir Crit Care Med. 2003 Dec 15;168(12):1438-44. doi: 10.1164/rccm.200301-072OC. Epub 2003 Sep 18.
- Background: PubMed 15599160Keenan SP, Sinuff T, Cook DJ, Hill NS. Does noninvasive positive pressure ventilation improve outcome in acute hypoxemic respiratory failure? A systematic review. Crit Care Med. 2004 Dec;32(12):2516-23. doi: 10.1097/01.ccm.0000148011.51681.e2.
- Background: PubMed 22762937Rello J, Perez M, Roca O, Poulakou G, Souto J, Laborda C, Balcells J, Serra J, Masclans JR; CRIPS investigators. High-flow nasal therapy in adults with severe acute respiratory infection: a cohort study in patients with 2009 influenza A/H1N1v. J Crit Care. 2012 Oct;27(5):434-9. doi: 10.1016/j.jcrc.2012.04.006. Epub 2012 Jul 2.
- Background: PubMed 25981908Frat 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.
- Background: PubMed 20206546Kernick J, Magarey J. What is the evidence for the use of high flow nasal cannula oxygen in adult patients admitted to critical care units? A systematic review. Aust Crit Care. 2010 May;23(2):53-70. doi: 10.1016/j.aucc.2010.01.001. Epub 2010 Mar 5.
- Background: PubMed 25371400Messika J, Ben Ahmed K, Gaudry S, Miguel-Montanes R, Rafat C, Sztrymf B, Dreyfuss D, Ricard JD. Use of High-Flow Nasal Cannula Oxygen Therapy in Subjects With ARDS: A 1-Year Observational Study. Respir Care. 2015 Feb;60(2):162-9. doi: 10.4187/respcare.03423. Epub 2014 Nov 4.
- Background: PubMed 25944940Vargas F, Saint-Leger M, Boyer A, Bui NH, Hilbert G. Physiologic Effects of High-Flow Nasal Cannula Oxygen in Critical Care Subjects. Respir Care. 2015 Oct;60(10):1369-76. doi: 10.4187/respcare.03814. Epub 2015 May 5.
- Background: PubMed 25110463Schwabbauer N, Berg B, Blumenstock G, Haap M, Hetzel J, Riessen R. Nasal high-flow oxygen therapy in patients with hypoxic respiratory failure: effect on functional and subjective respiratory parameters compared to conventional oxygen therapy and non-invasive ventilation (NIV). BMC Anesthesiol. 2014 Aug 7;14:66. doi: 10.1186/1471-2253-14-66. eCollection 2014.
- Background: PubMed 26521922Lemiale V, Mokart D, Mayaux J, Lambert J, Rabbat A, Demoule A, Azoulay E. The effects of a 2-h trial of high-flow oxygen by nasal cannula versus Venturi mask in immunocompromised patients with hypoxemic acute respiratory failure: a multicenter randomized trial. Crit Care. 2015 Nov 2;19:380. doi: 10.1186/s13054-015-1097-0.
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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.
Vanesa R Ruiz, RT principal investigator
Hospital Italiano de Buenos Aires
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Failure, run by Hospital Italiano de Buenos Aires.
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 3 inclusion and 1 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 9 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Heart Rate (time frame: 2 hours). The study lists 3 primary outcomes in all. 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 NCT03460119, which also lists 18 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 9 Mar 2018.