NCT04971148

Brief Summary

In this study, patients who are ready for extubation and indicated for high-flow nasal cannula therapy after extubation will be enrolled, the investigators would measure the patient peak tidal inspiratory flow (PTIF) pre and post extubation to explore the correlation between the two PTIFs. Moreover, different HFNC flows would be applied, to explore the patient response in terms of oxygenation and lung aeration to different flow ratios that matched and are above post-extubation PTIF.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
2 countries

2 active sites

Status
terminated

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

First Submitted

Initial submission to the registry

July 12, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 21, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

April 7, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2023

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

1.3 years

First QC Date

July 12, 2021

Last Update Submit

August 8, 2023

Conditions

Hypoxemic Respiratory Failure

Keywords

high-flow nasal cannulaflow settingpeak tidal inspiratory flowhypoxemia

Outcome Measures

Primary Outcomes (1)

  • SpO2/FIO2

    Twenty mins after each flow setting, pulse oximetry divided by fraction of inspired oxygen will be used to assess patient's oxygenation response to different flow

    20 minutes after each flow setting

Secondary Outcomes (2)

  • End-expiratory lung volume assessed by EIT

    20 minutes after each flow setting

  • self-evaluated comfort

    20 minutes after each flow setting

Study Arms (4)

HFNC flow set at patient peak tidal inspiratory flow

ACTIVE COMPARATOR

HFNC flow will be set at the level that matches patient peak tidal inspiratory flow

Other: HFNC flow set at patient peak tidal inspiratory flow

HFNC flow set at 1.33 times of patient peak tidal inspiratory flow

EXPERIMENTAL

HFNC flow will be set at the level that is 1.33 times of patient peak tidal inspiratory flow

Other: HFNC flow set at 1.33 times of patient peak tidal inspiratory flow

HFNC flow set at 1.67 times of patient peak tidal inspiratory flow

EXPERIMENTAL

HFNC flow will be set at the level that is 1.67 times of patient peak tidal inspiratory flow

Other: HFNC flow set at 1.67 times of patient peak tidal inspiratory flow

HFNC flow set at 2 times of patient peak tidal inspiratory flow

EXPERIMENTAL

HFNC flow will be set at the level that is 2 times of patient peak tidal inspiratory flow

Other: HFNC flow set at 2 times of patient peak tidal inspiratory flow

Interventions

HFNC flow set at patient peak tidal inspiratory flowOTHER

HFNC flow will be set at the level equal to patient peak tidal inspiratory flow

HFNC flow set at patient peak tidal inspiratory flow
HFNC flow set at 1.33 times of patient peak tidal inspiratory flowOTHER

HFNC flow will be set at 1.33 times of patient peak tidal inspiratory flow

HFNC flow set at 1.33 times of patient peak tidal inspiratory flow
HFNC flow set at 1.67 times of patient peak tidal inspiratory flowOTHER

HFNC flow will be set at 1.67 times of patient peak tidal inspiratory flow

HFNC flow set at 1.67 times of patient peak tidal inspiratory flow
HFNC flow set at 2 times of patient peak tidal inspiratory flowOTHER

HFNC flow will be set 2 times of patient peak tidal inspiratory flow

HFNC flow set at 2 times of patient peak tidal inspiratory flow

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult intubated patients aged between 18 to 90 years
  • Pass spontaneous breathing trial and receive the order to be extubated
  • Have at least one of the indications to use HFNC after extubation

You may not qualify if:

  • Need to use inhaled epoprostenol via HFNC
  • Pregnant
  • Unable to use resuscitation mask, such as facial trauma, claustrophobia
  • Non-English speaker
  • Inability to verbally communicate
  • Using extracorporeal membrane oxygenation (ECMO)
  • Hemodynamically unstable
  • Difficult airway

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rush university medical center

Chicago, Illinois, 60612, United States

Location

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Location

Related Publications (10)

  • 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

  • Rochwerg B, Granton D, Wang DX, Helviz Y, Einav S, Frat JP, Mekontso-Dessap A, Schreiber A, Azoulay E, Mercat A, Demoule A, Lemiale V, Pesenti A, Riviello ED, Mauri T, Mancebo J, Brochard L, Burns K. High flow nasal cannula compared with conventional oxygen therapy for acute hypoxemic respiratory failure: a systematic review and meta-analysis. Intensive Care Med. 2019 May;45(5):563-572. doi: 10.1007/s00134-019-05590-5. Epub 2019 Mar 19.

    PMID: 30888444BACKGROUND

  • 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: 27706464BACKGROUND

  • 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: 26975498BACKGROUND

  • Yasuda H, Okano H, Mayumi T, Narita C, Onodera Y, Nakane M, Shime N. Post-extubation oxygenation strategies in acute respiratory failure: a systematic review and network meta-analysis. Crit Care. 2021 Apr 9;25(1):135. doi: 10.1186/s13054-021-03550-4.

    PMID: 33836812BACKGROUND

  • Butt S, Pistidda L, Floris L, Liperi C, Vasques F, Glover G, Barrett NA, Sanderson B, Grasso S, Shankar-Hari M, Camporotaa L. Initial setting of high-flow nasal oxygen post extubation based on mean inspiratory flow during a spontaneous breathing trial. J Crit Care. 2021 Jun;63:40-44. doi: 10.1016/j.jcrc.2020.12.022. Epub 2020 Dec 27.

    PMID: 33621890BACKGROUND

  • Mauri T, Spinelli E, Dalla Corte F, Scotti E, Turrini C, Lazzeri M, Alban L, Albanese M, Tortolani D, Wang YM, Spadaro S, Zhou JX, Pesenti A, Grasselli G. Noninvasive assessment of airflows by electrical impedance tomography in intubated hypoxemic patients: an exploratory study. Ann Intensive Care. 2019 Jul 22;9(1):83. doi: 10.1186/s13613-019-0560-5.

    PMID: 31332551BACKGROUND

  • Mauri T, Alban L, Turrini C, Cambiaghi B, Carlesso E, Taccone P, Bottino N, Lissoni A, Spadaro S, Volta CA, Gattinoni L, Pesenti A, Grasselli G. Optimum support by high-flow nasal cannula in acute hypoxemic respiratory failure: effects of increasing flow rates. Intensive Care Med. 2017 Oct;43(10):1453-1463. doi: 10.1007/s00134-017-4890-1. Epub 2017 Jul 31.

    PMID: 28762180BACKGROUND

  • Li J, Jing G, Scott JB. Year in Review 2019: High-Flow Nasal Cannula Oxygen Therapy for Adult Subjects. Respir Care. 2020 Apr;65(4):545-557. doi: 10.4187/respcare.07663.

    PMID: 32213602RESULT

  • Li J, Scott JB, Fink JB, Reed B, Roca O, Dhand R. Optimizing high-flow nasal cannula flow settings in adult hypoxemic patients based on peak inspiratory flow during tidal breathing. Ann Intensive Care. 2021 Nov 27;11(1):164. doi: 10.1186/s13613-021-00949-8.

    PMID: 34837553RESULT

MeSH Terms

Conditions

Respiratory InsufficiencyHypoxia

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jie Li, PhD

    Rush University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Patients will be randomized to receive different HFNC flow settings (matching their peak tidal inspiratory flow \[PTIF\], 1.33 times of PTIF, 1.67 times of PTIF and 2 times of PTIF)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2021

First Posted

July 21, 2021

Study Start

April 7, 2022

Primary Completion

August 8, 2023

Study Completion

August 8, 2023

Last Updated

August 14, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will share

De-identified patient data will be shared upon reasonable request 3 months after publication.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
3 months after the study is published
Access Criteria
the investigators need to send their IRB approved research protocol to Jie\ li@rush.edu

Locations

US(1)ES(1)