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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03460119
Other study ID # 3106
Secondary ID
Status Completed
Phase N/A
First received February 20, 2018
Last updated March 2, 2018
Start date July 1, 2015
Est. completion date January 31, 2017

Study information

Verified date February 2018
Source Hospital Italiano de Buenos Aires
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 43
Est. completion date January 31, 2017
Est. primary completion date January 31, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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:

- Pulse oximetry > 90% breathing room air

Study Design


Related Conditions & MeSH terms


Intervention

Device:
High 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?).

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hospital Italiano de Buenos Aires

References & Publications (18)

El-Khatib MF. High-flow nasal cannula oxygen therapy during hypoxemic respiratory failure. Respir Care. 2012 Oct;57(10):1696-8. — View Citation

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. Epub 2003 Sep 18. — View Citation

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, Béduneau G, Delétage-Métreau 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Rello J, Pérez 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. — View Citation

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. — View Citation

Roca O, Hernández G, Díaz-Lobato S, Carratalá JM, Gutiérrez 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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 18 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Heart Rate The closest value of Heart Rate before starting HFNC, and two hours later was collected from the electronic clinical history. 2 hours
Primary Respiratory Rate The closest value of Respiratory Rate before starting HFNC, and two hours later was collected from the electronic clinical history. 2 hours
Primary 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 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. 2 hours
Secondary 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. 3 minutes
Secondary Average time of use the HFNC The total hours of use of HFNC were collected from the electronic clinical history. until 28 days
Secondary Delay of HFNC treatment The hours between the admission to HFNC initiation were collected from the electronic clinical history. until 24hs
Secondary Efficacy of HFNC treatment When the patient did not need for escalation to other non-invasive or invasive ventilatory support. 28 days
Secondary 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. 28 days
Secondary Mortality rate at 28 day from ED admission The number of patients who died after requiring HFNCO were collected from the electronic clinical history 28 days
Secondary 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 28 days
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