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CompletedNCT03460119HFNCUpdated Mar 9, 2018

High Flow Nasal Cannula in the Emergency Department

An observational study in Acute Respiratory Failure, sponsored by Hospital Italiano de Buenos Aires. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-09.

Primary conditionnone(registry's first term: Emergencies)No conditionIs this wrong?Emergencies describes something many studies share rather than a condition a study is about. The study names no condition we can place it under, so it is not compared with other studies by condition.

Sponsored by Hospital Italiano de Buenos Aires · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
43
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Acute Respiratory Failure

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Keywords

  • High Flow Nasal Cannula
  • Emergency department
  • Respiratory care
03

In context

Lead sponsor

Hospital Italiano de Buenos Aires is the lead sponsor of 133 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Pulse oximetry > 90% breathing room air
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
43 participants (actual)
Patient registry
No

Interventions

  • DeviceHigh Flow Nasal Cannula Oxygen

    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Ⓡ).

06

What researchers measure

Primary outcomes

  1. Heart Rate

    The closest value of Heart Rate before starting HFNC, and two hours later was collected from the electronic clinical history.

    Time frame: 2 hours

  2. Respiratory Rate

    The closest value of Respiratory Rate before starting HFNC, and two hours later was collected from the electronic clinical history.

    Time frame: 2 hours

  3. 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).

    Time frame: 2 hours

Secondary outcomes

  1. 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.

    Time frame: 2 hours

  2. 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.

    Time frame: 3 minutes

  3. Average time of use the HFNC

    The total hours of use of HFNC were collected from the electronic clinical history.

    Time frame: until 28 days

  4. Delay of HFNC treatment

    The hours between the admission to HFNC initiation were collected from the electronic clinical history.

    Time frame: until 24hs

  5. Efficacy of HFNC treatment

    When the patient did not need for escalation to other non-invasive or invasive ventilatory support.

    Time frame: 28 days

  6. 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.

    Time frame: 28 days

  7. Mortality rate at 28 day from ED admission

    The number of patients who died after requiring HFNCO were collected from the electronic clinical history

    Time frame: 28 days

  8. 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

    Time frame: 28 days

07

Study locations

No study locations are listed for this record.

08

References and documents

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 27121707 ↗
  • El-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 23013907 ↗
  • Sztrymf 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 21958974 ↗
  • Ferrer 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 14500259 ↗
  • Keenan 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 15599160 ↗
  • Rello 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 22762937 ↗
  • 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. PubMed 25981908 ↗
  • Kernick 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 20206546 ↗
  • Messika 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 25371400 ↗
  • Vargas 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 25944940 ↗
  • Schwabbauer 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 25110463 ↗
  • Lemiale 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 26521922 ↗
  • Sztrymf 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 21946925 ↗
  • Lenglet 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 22417844 ↗
  • Rittayamai 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 ↗
  • Jeong JH, Kim DH, Kim SC, Kang C, Lee SH, Kang TS, Lee SB, Jung SM, Kim DS. Changes in arterial blood gases after use of high-flow nasal cannula therapy in the ED. Am J Emerg Med. 2015 Oct;33(10):1344-9. doi: 10.1016/j.ajem.2015.07.060. Epub 2015 Jul 30. PubMed 26319192 ↗
  • Hughes J, Doolabh A. Heated, humidified, high-flow nasal oxygen usage in the adult Emergency Department. Australas Emerg Nurs J. 2016 Nov;19(4):173-178. doi: 10.1016/j.aenj.2016.05.003. Epub 2016 Jun 6. PubMed 27283891 ↗
  • Jones PG, Kamona S, Doran O, Sawtell F, Wilsher M. Randomized Controlled Trial of Humidified High-Flow Nasal Oxygen for Acute Respiratory Distress in the Emergency Department: The HOT-ER Study. Respir Care. 2016 Mar;61(3):291-9. doi: 10.4187/respcare.04252. Epub 2015 Nov 17. PubMed 26577199 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2015 to primary completion in Jan 2017, 18 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 20, 2018
First posted
Mar 9, 2018
StartActual
Jul 1, 2015
Primary completionActual
Jan 31, 2017
CompletionActual
Jan 31, 2017
Last update
Mar 9, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03460119
Responsible party
Sponsor
First posted
Mar 9, 2018
Start date
Jul 1, 2015
Primary completion
Jan 31, 2017
Completion
Jan 31, 2017
Last update
Mar 9, 2018

Study contacts

Vanesa R Ruiz, RT
principal investigator · Hospital Italiano de Buenos Aires

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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