NCT03361683

Brief Summary

Patients intubated due to acute respiratory failure have a high risk of infectious complications, airway injuries and multiple organic failure, so performing a successful extubation from mechanical ventilation is key. Between 10 and 20% of patients develop extubation failure, which is related to an increased in-hospital death rate, infections, higher costs and longer hospital stays. High-flow nasal oxygen therapy delivers heated, humidified air at flows up to 60L/min, and an oxygen concentration close to 100%, providing a fresh air reservoir at the naseo-pharyngeal level, evening out the peak inspiratory flow rate of the patient, improving air conductance, promoting secretion management, increasing end-expiratory lung volume, and applying a positive end-expiratory pressure. Such effects result in decreased breathing work, dyspnea relief, improved use tolerance, increased oxygenation, and lower fraction of inspired oxygen in patients with hypoxemic respiratory failure. High-flow oxygen therapy has recently been described to decrease extubation failure in a group of patients classified with low failure risk, in comparison to Venturi mask, and it was not inferior to non-invasive mechanical ventilation in high risk patients. However, it is worth pointing out that a large percentage of the patients included in such studies did not develop acute respiratory failure primarily. Given the beneficial effects described above, the investigators hypothesize that high-flow nasal oxygen therapy decreases the risk of extubation failure in a group of patients that required invasive mechanical ventilation due to primary acute hypoxemic respiratory failure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
127

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

October 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 8, 2017

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 5, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2019

Completed
Last Updated

August 8, 2019

Status Verified

July 1, 2019

Enrollment Period

1.7 years

First QC Date

November 8, 2017

Last Update Submit

August 6, 2019

Conditions

Extubation Failure

Keywords

High-Flow nasal oxygen

Outcome Measures

Primary Outcomes (1)

  • Post-extubation failure

    Number of patients with extubation failure criteria in each group

    First 48 hours

Secondary Outcomes (12)

  • PaO2/FiO2 Ratio Record.

    Post-extubation period and up to 48 hours later.

  • Determination of FiO2 Requirements.

    Post-extubation period and up to 48 hours later.

  • Respiratory Rate Record at Defined Intervals.

    Post-extubation period and up to 48 hours later.

  • Heart Rate Record at Defined Intervals.

    Post-extubation period and up to 48 hours later.

  • Mean Arterial Pressure Record at Defined Intervals.

    Post-extubation period and up to 48 hours later.

  • +7 more secondary outcomes

Study Arms (2)

High-flow nasal oxygen

EXPERIMENTAL

Randomized patients will receive oxygen through a high flow nasal device capable of delivering humidified, heated air at an output rate of 40 L/min

Device: High-flow nasal oxygen

Conventional oxygen

ACTIVE COMPARATOR

Randomized patients will receive oxygen through a Venturi mask at an air flow of 15 L/min

Device: Venturi mask

Interventions

High-flow nasal oxygenDEVICE

Randomized patients will receive oxygen through a high nasal flow device capable of delivering humidified, heated air at an output rate of 40 L/min

High-flow nasal oxygen
Venturi maskDEVICE

Randomized patients will receive oxygen through a Venturi mask at an air flow of 15 L/min

Conventional oxygen

Eligibility Criteria

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

You may qualify if:

  • Hypoxemic primary acute respiratory failure
  • Invasive mechanical ventilation for at least 48 hours
  • Successful Spontaneous Breathing Trial

You may not qualify if:

  • Immediate indication for invasive mechanical ventilation
  • Immediate indication for non-invasive mechanical ventilation
  • Self-extubation
  • One or more failed Spontaneous Breathing Trial
  • Chronic respiratory failure
  • Neuromuscular diseases
  • Tracheostomy.
  • Nasal cavity pathology
  • Facial surgery
  • Failure to authorize the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Medical Science and Nutrition Salvador Zubirán,

México, 14080, Mexico

Location

Related Publications (14)

  • Chanques G, Constantin JM, Sauter M, Jung B, Sebbane M, Verzilli D, Lefrant JY, Jaber S. Discomfort associated with underhumidified high-flow oxygen therapy in critically ill patients. Intensive Care Med. 2009 Jun;35(6):996-1003. doi: 10.1007/s00134-009-1456-x. Epub 2009 Mar 18.

    PMID: 19294365RESULT

  • Dysart K, Miller TL, Wolfson MR, Shaffer TH. Research in high flow therapy: mechanisms of action. Respir Med. 2009 Oct;103(10):1400-5. doi: 10.1016/j.rmed.2009.04.007. Epub 2009 May 21.

    PMID: 19467849RESULT

  • Dewan NA, Bell CW. Effect of low flow and high flow oxygen delivery on exercise tolerance and sensation of dyspnea. A study comparing the transtracheal catheter and nasal prongs. Chest. 1994 Apr;105(4):1061-5. doi: 10.1378/chest.105.4.1061.

    PMID: 8162725RESULT

  • Ricard JD. High flow nasal oxygen in acute respiratory failure. Minerva Anestesiol. 2012 Jul;78(7):836-41. Epub 2012 Apr 24.

    PMID: 22531566RESULT

  • Groves N, Tobin A. High flow nasal oxygen generates positive airway pressure in adult volunteers. Aust Crit Care. 2007 Nov;20(4):126-31. doi: 10.1016/j.aucc.2007.08.001. Epub 2007 Oct 10.

    PMID: 17931878RESULT

  • Corley A, Caruana LR, Barnett AG, Tronstad O, Fraser JF. Oxygen delivery through high-flow nasal cannulae increase end-expiratory lung volume and reduce respiratory rate in post-cardiac surgical patients. Br J Anaesth. 2011 Dec;107(6):998-1004. doi: 10.1093/bja/aer265. Epub 2011 Sep 9.

    PMID: 21908497RESULT

  • Spence KL, Murphy D, Kilian C, McGonigle R, Kilani RA. High-flow nasal cannula as a device to provide continuous positive airway pressure in infants. J Perinatol. 2007 Dec;27(12):772-5. doi: 10.1038/sj.jp.7211828. Epub 2007 Aug 30.

    PMID: 17762844RESULT

  • Chidekel A, Zhu Y, Wang J, Mosko JJ, Rodriguez E, Shaffer TH. The effects of gas humidification with high-flow nasal cannula on cultured human airway epithelial cells. Pulm Med. 2012;2012:380686. doi: 10.1155/2012/380686. Epub 2012 Sep 3.

    PMID: 22988501RESULT

  • Sreenan C, Lemke RP, Hudson-Mason A, Osiovich H. High-flow nasal cannulae in the management of apnea of prematurity: a comparison with conventional nasal continuous positive airway pressure. Pediatrics. 2001 May;107(5):1081-3. doi: 10.1542/peds.107.5.1081.

    PMID: 11331690RESULT

  • Roca O, Riera J, Torres F, Masclans JR. High-flow oxygen therapy in acute respiratory failure. Respir Care. 2010 Apr;55(4):408-13.

    PMID: 20406507RESULT

  • Maggiore SM, Idone FA, Vaschetto R, Festa R, Cataldo A, Antonicelli F, Montini L, De Gaetano A, Navalesi P, Antonelli M. Nasal high-flow versus Venturi mask oxygen therapy after extubation. Effects on oxygenation, comfort, and clinical outcome. Am J Respir Crit Care Med. 2014 Aug 1;190(3):282-8. doi: 10.1164/rccm.201402-0364OC.

    PMID: 25003980RESULT

  • 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: 22417844RESULT

  • Hernandez G, Vaquero C, Gonzalez P, Subira C, Frutos-Vivar F, Rialp G, Laborda C, Colinas L, Cuena R, Fernandez R. Effect of Postextubation High-Flow Nasal Cannula vs Conventional Oxygen Therapy on Reintubation in Low-Risk Patients: A Randomized Clinical Trial. JAMA. 2016 Apr 5;315(13):1354-61. doi: 10.1001/jama.2016.2711.

    PMID: 26975498RESULT

  • Hernandez G, Vaquero C, Colinas L, Cuena R, Gonzalez P, Canabal A, Sanchez S, Rodriguez ML, Villasclaras A, Fernandez R. Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation on Reintubation and Postextubation Respiratory Failure in High-Risk Patients: A Randomized Clinical Trial. JAMA. 2016 Oct 18;316(15):1565-1574. doi: 10.1001/jama.2016.14194.

    PMID: 27706464RESULT

Study Officials

  • Jose de Jesus Rodriguez-Andoney, MD

    National Institute of Medical Science and Nutrition Salvador Zubirán

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2017

First Posted

December 5, 2017

Study Start

October 1, 2017

Primary Completion

June 30, 2019

Study Completion

July 30, 2019

Last Updated

August 8, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)