NCT03460119

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 9, 2018

Completed
Last Updated

March 9, 2018

Status Verified

February 1, 2018

Enrollment Period

1.6 years

First QC Date

February 20, 2018

Last Update Submit

March 2, 2018

Conditions

Acute Respiratory Failure

Keywords

High Flow Nasal CannulaEmergency departmentRespiratory care

Outcome Measures

Primary Outcomes (3)

  • Heart Rate

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

    2 hours

  • Respiratory Rate

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

    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).

    2 hours

Secondary Outcomes (8)

  • Initial HFNC setting

    2 hours

  • Acute respiratory failure etiology

    3 minutes

  • Average time of use the HFNC

    until 28 days

  • Delay of HFNC treatment

    until 24hs

  • Efficacy of HFNC treatment

    28 days

  • +3 more secondary outcomes

Interventions

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Ⓡ).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • \- Pulse oximetry \> 90% breathing room air

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (18)

  • 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.

    PMID: 27121707BACKGROUND

  • 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.

    PMID: 23013907BACKGROUND

  • 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.

    PMID: 21958974BACKGROUND

  • 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.

    PMID: 14500259BACKGROUND

  • 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.

    PMID: 15599160BACKGROUND

  • 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.

    PMID: 22762937BACKGROUND

  • 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.

    PMID: 25981908BACKGROUND

  • 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.

    PMID: 20206546BACKGROUND

  • 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.

    PMID: 25371400BACKGROUND

  • 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.

    PMID: 25944940BACKGROUND

  • 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.

    PMID: 25110463BACKGROUND

  • 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.

    PMID: 26521922BACKGROUND

  • 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.

    PMID: 21946925BACKGROUND

  • 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.

    PMID: 22417844BACKGROUND

  • 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.

    PMID: 26060321BACKGROUND

  • 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.

    PMID: 26319192BACKGROUND

  • 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.

    PMID: 27283891BACKGROUND

  • 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.

    PMID: 26577199BACKGROUND

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Vanesa R Ruiz, RT

    Hospital Italiano de Buenos Aires

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2018

First Posted

March 9, 2018

Study Start

July 1, 2015

Primary Completion

January 31, 2017

Study Completion

January 31, 2017

Last Updated

March 9, 2018

Record last verified: 2018-02