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

Hypoxemic Respiratory Failure Clinical Trial

Official title:

Correlation of Peak Tidal Inspiratory Flow Measured Before and After Extubation in Adult Patients With Hypoxemia, and Patients' Responses to Different Flows Above Their Peak Tidal Inspiratory Flow During High Flow Nasal Cannula Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04971148
• Other study ID #: HFNC-Flow-004
• Status: Terminated
• Phase: N/A
• Start date: April 7, 2022
• Est. completion date: August 8, 2023

Study information

• Verified date: August 2023
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: August 8, 2023
• Est. primary completion date: August 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypoxemic Respiratory Failure
• Hypoxia
• Respiratory Aspiration
• Respiratory Insufficiency

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Universitari Vall d'Hebron	Barcelona
United States	Rush university medical center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Rush University Medical Center	Hospital Vall d'Hebron

Countries where clinical trial is conducted

United States,  Spain, 

References & Publications (10)

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. — 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, 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. — View Citation

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. Erratum In: JAMA. 2016 Nov 15;316(19):2047-2048. JAMA. 2017 Feb 28;317(8):858. — View Citation

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. — View Citation

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. — View Citation

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- — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	End-expiratory lung volume assessed by EIT	Twenty mins after each flow setting, electrical impedance tomography (EIT) will be used to assess patient's end -expiratory lung volume 20 mins after each flow setting	20 minutes after each flow setting
Secondary	self-evaluated comfort	Twenty mins after each flow setting, patient comfort will be assessed using a visual numerical scale with a score of 0 as the worst and 10 as the best comfort	20 minutes after each flow setting