Correlation of Peak Tidal Inspiratory Flow Measured Before and After Extubation in Adult Patients With Hypoxemia

NCT ID: NCT04971148

Last Updated: 2023-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-07

Study Completion Date

2023-08-08

Brief Summary

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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.

Detailed Description

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High-flow nasal cannula (HFNC) oxygen therapy has been shown to improve oxygenation, reduce the need for intubation for patients with acute hypoxemic respiratory failure (AHRF) and avoid reintubation for post-extubation patients who had high-risk factors. HFNC refers to the delivery of gas at flows that exceed the patient peak inspiratory flow during tidal breathing, However, patient peak tidal inspiratory flow (PTIF) is found to vary greatly among different patients, from 20 to 50 L/min, making it difficult to properly set HFNC in a way to achieve the desired effects. In two recently published studies in intubated patients, PTIF varied from 25-65 L/min or 40-80 L/min, thus this study aims to investigate the correlation between pre-extubation PTIF in different modalities of SBT and post-extubation PTIF for adult patients, who are indicated to use HFNC immediately after extubation. In addition, the investigators aim to explore the patient response in terms of oxygenation and lung aeration to different flow ratios that matched and are above post-extubation PTIF.

Conditions

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Hypoxemic Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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)
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HFNC flow set at patient peak tidal inspiratory flow

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

Group Type ACTIVE_COMPARATOR

HFNC flow set at patient peak tidal inspiratory flow

Intervention Type OTHER

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

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

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

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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

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

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

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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

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

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

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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

Interventions

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HFNC flow set at patient peak tidal inspiratory flow

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

Intervention Type OTHER

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

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

Intervention Type OTHER

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

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

Intervention Type OTHER

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

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Vall d'Hebron

OTHER

Sponsor Role collaborator

Rush University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jie Li, PhD

Role: PRINCIPAL_INVESTIGATOR

Rush University

Locations

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Rush university medical center

Chicago, Illinois, United States

Site Status

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Site Status

Countries

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United States Spain

References

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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.

Reference Type BACKGROUND
PMID: 25981908 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30888444 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27706464 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26975498 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33836812 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33621890 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31332551 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28762180 (View on PubMed)

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.

Reference Type RESULT
PMID: 32213602 (View on PubMed)

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.

Reference Type RESULT
PMID: 34837553 (View on PubMed)

Other Identifiers

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HFNC-Flow-004

Identifier Type: -

Identifier Source: org_study_id

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